Infantile Apnea and Home Monitoring National Institutes of Health Consensus Development Conference Statement September 29-October 1, 1986 This statement is more than five years old and is provided solely for historical purposes. Due to the cumulative nature of medical research, new knowledge has inevitably accumulated in this subject area in the time since the statement was initially prepared. Thus some of the material is likely to be out of date, and at worst simply wrong. For reliable, current information on this and other health topics, we recommend consulting the National Institutes of Health's MedlinePlus http://www.nlm.nih.gov/medlineplus/. This statement was originally published as: Infantile Apnea and Home Monitoring. NIH Consens Statement 1986 Sep 29-Oct 1;6(6):1-10. For making bibliographic reference to the statement in the electronic form displayed here, it is recommended that the following format be used: Infantile Apnea and Home Monitoring. NIH Consens Statement Online 1986 Sep 29-Oct 1 [cited year month day];6(6):1-10. Introduction Apnea has long been recognized as a clinical problem in infants. Considerable investigative and clinical attention has been directed toward this condition. Although progress has been made and certain categories of apnea have been delineated, etiology remains unclear in many situations. Furthermore, the condition is common in certain populations, such as in infants born prematurely. Whether an apneic event occurs independently or in association with a pathophysiologic process such as sepsis or an environmental factor such as change in temperature, there is concern about possible effects of interrupted breathing. Measurement of normal and abnormal physiologic processes such as breathing patterns is facilitated by devices. Monitors have emerged in the laboratory and hospital and have contributed to the discovery of new knowledge and management of abnormalities. Monitoring in this document refers to the use of electronic devices. Technical advances, especially in electronics, have resulted in many devices that seem to be accurate, useful, and safe. Others are of questionable value. Sudden infant death syndrome (SIDS) was recognized before this century but did not receive close attention until relatively recently. Public Law 93-270, the Sudden Infant Death Syndrome Act of 1974, gave the Public Health Service the mandate to stimulate research and administer counseling and information programs. In 1972, a paper reported that two of five infants with documented prolonged sleep apnea died of SIDS. A great deal of attention during the 1970's was directed toward the relationship of apnea and SIDS. As the 1970's and 1980's unfolded, the use of monitors in the home environment to detect apnea expanded. Research and clinical programs produced many reports about the merits of this activity, and controversy emerged. In an effort to resolve this controversy, the Consensus Development Program at the National Institutes of Health has now directed its attention to this subject, and the panel for this Consensus Development Conference on Infantile Apnea and Home Monitoring was asked to focus on the following questions: What is known about the relation of neonatal and infant apnea to each other and to mortality (especially SIDS) and morbidity in infancy? What are the efficacy and safety of currently available home devices for detecting infant apnea? What evidence exists regarding the effectiveness of home monitoring in reducing infant mortality (especially SIDS) and morbidity? Based on the above, what recommendations can be made at present regarding the circumstances for use of home apnea monitoring in infancy? What further research is needed on home apnea monitoring for infants. Definitions Expression of concepts and terminology has been difficult. Continued intense efforts directed toward definitions are important. The following definitions are used in this document. Apnea--Cessation of respiratory air flow. The respiratory pause may be central or diaphragmatic (i.e., no respiratory effort), obstructive (usually due to upper airway obstruction), or mixed. Short (15 seconds), central apnea can be normal at all ages. Pathologic Apnea--A respiratory pause is abnormal if it is prolonged (20 seconds) or associated with cyanosis; abrupt, marked pallor or hypotonia; or bradycardia. Periodic Breathing--A breathing pattern in which there are three or more respiratory pauses of greater than 3 seconds' duration with less than 20 seconds of respiration between pauses. Periodic breathing can be a normal event. Apnea of Prematurity (AOP)--Periodic breathing with pathologic apnea in a premature infant. Apnea of prematurity usually ceases by 37 weeks gestation (menstrual dating), but occasionally persists to several weeks past term. Asymptomatic Premature Infants--Preterm infants who either never had AOP or whose AOP has resolved. Symptomatic Premature Infants--Preterm infants who continue to have pathologic apnea at the time when they otherwise would be ready for discharge. Apparent Life-Threatening Event (ALTE)--An episode that is frightening to the observer and that is characterized by some combination of apnea (central or occasionally obstructive), color change (usually cyanotic or pallid but occasionally erythematous or plethoric), marked change in muscle tone (usually marked limpness), choking, or gagging. In some cases, the observer fears that the infant has died. Previously used terminology such as "aborted crib death" or "near-miss SIDS" should be abandoned because it implies a possibly misleadingly close association between this type of spell and SIDS. Apnea of Infancy (AOI)--An unexplained episode of cessation of breathing for 20 seconds or longer, or a shorter respiratory pause associated with bradycardia, cyanosis, pallor, and/or marked hypotonia. The terminology "apnea of infancy" generally refers to infants who are greater than 37 weeks gestational age at onset of pathologic apnea. AOI should be reserved for those infants for whom no specific cause of ALTE can be identified. In other words, these are infants whose ALTE was idiopathic and believed to be related to apnea. Sudden Infant Death Syndrome (SIDS)---The sudden death of any infant or young child, which is unexplained by history and in which a thorough postmortem examination fails to demonstrate an adequate explanation of cause of death. A pediatrician commentator at the public meeting stated: "We need to be taken out of confusion of regional opinions, the pressures of public perceptions, and unfounded technological claims and be given guidance on what we do while we await data." It is hoped that this consensus statement and the final report that follows will serve as helpful educational tools and provide guidance while stimulating the research process leading to new knowledge.   What Is Known About the Relation of Neonatal and Infant Apnea to Each Other and to Mortality (Especially SIDS) and Morbidity in Infancy? There is no evidence that apnea of prematurity is an independent risk factor for infant apnea. Apnea of prematurity, a developmental phenomenon, usually resolves by the time the infant is 34 to 36 weeks gestational age. In many infants, a pattern of periodic breathing may persist until several weeks past term; in fact, some periodic breathing is probably normal at any age. There is evidence that apnea of prematurity is not a risk factor for SIDS. Although preterm infants make up a disproportionate share of all infants with SIDS (18 percent), there is evidence that apnea of prematurity is not an independent risk factor for SIDS. In the NICHD Cooperative Epidemiological Study of SIDS Risk Factors, there was no difference in the incidence of reported (hospital record) apnea in the infants dying of SIDS compared with a control group matched for birth weight and ethnicity. This observation was true for all birth-weight-specific groups. An apparent life-threatening event is a risk factor for sudden death (including SIDS). The term ALTE describes a clinical syndrome. A variety of identifiable diseases or conditions can cause such episodes (e.g., ALTE secondary to gastroesophageal reflux or ALTE secondary to seizures), but in approximately one-half of the cases, despite extensive workup, no cause can be identified. These episodes can occur during sleep, wakefulness, or feeding and are in infants who are generally of greater than 37 weeks gestational age at the time of onset. The reported mortality of patients with apnea of infancy (AOI), some of whom have been electronically monitored at home, varies from 0 to 6 percent. This variability is due to differences in terminology and the inherent heterogeneity of the population. The mortality of other ALTE subgroups is unknown. It must not always be assumed, however, that once a specific cause of ALTE has been identified, the infant is no longer at increased risk of sudden unexpected death. Certain subgroups of infants with ALTE may be at higher risk. There are data to suggest that infants presenting with an apneic spell during sleep who were perceived to require resuscitation may have a mortality as high as 10 percent despite the use of home monitors. Infants with this ominous history are rare. Infants with two or more such episodes may have up to a threefold further increase in risk of death. There is no evidence that apnea of prematurity per se causes subsequent morbidity. Although early studies suggested an increased incidence of spastic diplegia in preterm infants with a history of apnea and bradycardia, many of these infants may have had other conditions that may have caused the apnea and could confound studies of developmental outcome. ALTE may be associated with an increased morbidity. Rarely, infants who experience severe ALTE also develop serious neurodevelopmental sequelae (e.g., vegetative state). Some ALTE survivors demonstrate behavioral and neurodevelopmental abnormalities, but there is no proof that this is a result of ALTE. Infants with a history of ALTE or apnea of prematurity comprise only a very small proportion of total SIDS cases. The NICHD Cooperative Epidemiological Study of SIDS cases found only 2 to 4 percent had a hospital record of apnea of prematurity and less than 7 percent had a history of ALTE.   What Are the Efficacy and Safety of Currently Available Home Devices for Detecting Infant Apnea? Essential Features An infant cardiorespiratory monitor must meet essential criteria to be of clinical value. Primary among these is the ability to recognize central, obstructive, or mixed apneas and/or bradycardia as they occur. Alarms that accurately reflect the predisposing condition must consistently alert and be understandable to the care giver. In other words, the monitor must be efficacious in recognizing apnea and triggering its alarm for prolonged apnea. In addition, the monitor must be capable of monitoring its own internal essential functions to assure proper operation. It must be noninvasive and easy to use and understand. The best of the currently available impedance-based cardiorespiratory monitors meet many but not all of the essential criteria. Although there are several methods that can be used for sensing breathing, only a few of these have been applied in currently available home cardiorespiratory monitors. Of these, the transthoracic electrical impedance monitors are by far the most frequently applied and have the widest availability in the United States. These monitors are generally efficacious in identifying and alarming on central apneas; however, there are some situations where "breaths" are detected during apparent apneas (false negative) and other cases where apneas are indicated even though the infant is breathing (false positive). The former often is related to cardiogenic artifact, a significant problem with impedance monitors, or to motion artifact resulting from active or passive infant movement. The latter is associated with low amplitude respiration signals that can occur with impedance monitors even though other sensors of ventilation simultaneously monitoring the infant do not show significant hypoventilation. False positive alarms also can be seen in some rare cases as a result of the signal processing in the monitor to reduce false negative apnea detection. Obstructive and mixed apneas, on the other hand, are not directly detected by presently available impedance monitors. Some noninvasive methods of sensing breathing other than transthoracic impedance might be more efficacious than impedance. Cardiogenic artifact can be significant with transthoracic impedance monitors, and it also is seen to a lesser extent in other sensors of breathing. These other methods also may have reduced sensitivity to some infant motion. Primary among these sensors are the abdominal strain gauge, inductance plethysmograph, and nasal thermistor. The latter two also may be able to detect obstructive apnea. Cardiac monitors may be sufficient for monitoring some infants. Cardiac monitors, or the cardiac monitor portion of a cardiorespiratory monitor, that utilize the electrocardiogram have fewer false positive or negative alarms than the respiration monitors. Although these devices do not meet the essential criteria listed above and are affected by motion artifact, they can, for the most part, reliably recognize conditions of tachycardia and bradycardia. In some cases, it may be sufficient to monitor heart rate alone for infants at home. Heart rate monitors are less expensive than cardiorespiratory monitors, which makes this alternative attractive. Future work is needed to determine whether this is a valid approach. Desirable Features Other features of monitors for home use might be desirable, even though no documented evidence exists to that effect at the present time. These features include the capability of capturing and storing patterns surrounding significant events for later analysis, detection of hypoxemia secondary to hypoventilation or apnea as well as the detection of the hypoventilation itself, estimation of tidal volume, and the identification of heart rate patterns and variability as well as cardiac arrhythmias. No presently available home monitor meets all these criteria. Thus, new instruments should be developed so that monitors with these features can be made available for research purposes. It is important to note that the development of hard copy monitors alone is not sufficient to identify false alarms. It is essential that these devices provide sufficient information to fully characterize "alarm conditions." Even so, it will not be possible to use this technique to document false negative apnea detection. The pulse oximeter offers opportunities to monitor blood hemoglobin oxygen saturation as a means of detecting hypoxemia secondary to apnea and hypoventilation. This instrument should be evaluated further in this application, with special attention paid to the effect of signal processing on the measured signal and methods of minimizing motion artifact. Other Considerations A set of minimal standards for monitors is needed. An important issue in considering monitor efficacy is the development of appropriate standards and test methods. The development of such standards with clinical as well as technical input to the process needs to be encouraged. Testing procedures must be relevant to the clinical application of the devices if they are to be meaningful. Manufacturers should publish performance characteristics of monitors for use by physicians when prescribing. The need for mandatory standards may be necessary if voluntary standards cannot be developed and followed within a reasonable time (1 to 2 years). The reporting of problems of efficacy and safety with monitors must be mandatory. The marketing of "over the counter" monitors should be strongly discouraged. Monitoring devices should not be made available to consumers without professional recommendation and supervision. Because it is unlikely that the efficacy of such devices would be markedly improved over present monitors, such widespread availability of monitors might lead to a significant increase in the number of infants referred to apnea centers due to false alarms of the instrument. Furthermore, the support systems available to parents who purchase such machines would be nonexistent or not uniform. In addition, the care giver needs to be specially trained in the use of the monitor, including knowing how to operate and apply the instrument and knowing what actions to take when the alarm sounds. This training is essential for monitors to be effective. With the exception of a few isolated incidents, home cardiorespiratory monitors appear to be safe. A few isolated problems have been reported, and these problems subsequently have been largely corrected.   What Evidence Exists Regarding the Effectiveness of Home Monitoring in Reducing Infant Mortality (Especially SIDS) and Morbidity? Effectiveness of Home Monitoring For the purpose of this statement, effectiveness means the ability to assist in preventing death of infants for whom home monitors are prescribed. This implies a proper choice of home monitoring instruments, adequate training, and continuous logistic and professional support of care takers and their acceptance and persistence with recommended management. In addition, effectiveness implies the ability of care takers to abort an apneic episode by techniques they have learned, including resuscitation. Home Monitoring for ALTE There are no reports of scientifically designed studies of the effectiveness of home monitoring for ALTE. There are, however, several case studies from apnea programs that suggest that home monitoring may be an appropriate intervention for some infants. These include infants with ALTE who present with an initial episode requiring vigorous stimulation or resuscitation. Home Monitoring for Subsequent Siblings of SIDS Victims There are no reports of scientifically designed studies of the effectiveness of home monitoring for subsequent siblings of SIDS victims. While this is an emotionally charged issue, the decision to monitor subsequent siblings in families with a single SIDS loss cannot be substantiated from existing clinical reports. No clinical studies have adequately investigated home monitoring of siblings of SIDS or the survivor of a twin pair. Home Monitoring for Premature Infants There are no reports of scientifically designed studies of the effectiveness of home monitoring of premature infants. Reports from some neonatal intensive care units indicate that for some symptomatic premature infants home monitoring may be a successful alternative to prolonged hospitalization after the infants meet all other criteria for hospital discharge. Home Monitoring for Other Pathologic Conditions There are no reports of scientifically designed studies of the effectiveness of home monitoring for other pathologic conditions. Clinical evidence may support the decision to monitor infants with tracheostomies at home. Other conditions with high postneonatal mortality such as severe bronchopulmonary dysplasia may warrant home monitoring, although supportive data are lacking. SIDS Mortality Trends and Home Monitoring Evidence from several communities in which SIDS surveillance has been maintained for a decade or more indicates that annual SIDS rates vary from year to year but have not declined perceptibly since the introduction of home monitoring. The proportion of SIDS victims with a history of apnea is too small for the impact of home monitoring of this group to be perceived. Mortality from all other causes of death during infancy has fallen dramatically over the corresponding timespan. It is, therefore, unlikely that an increase in deaths from some other cause has been offset by benefits from the use of home monitors in the community. Home Monitoring and Morbidity There are no studies of long-term morbidity associated with apnea or the use of home monitors, but clinical evidence suggests that research on this question might be fruitful. No evidence exists to support the contention that home monitoring prevents development of seizures, intellectual deficits, or developmental disorders. Problems in Dealing With Studies of Effectiveness No randomized studies of adequate size have addressed effectiveness of home monitoring for any category of patients. There have been several published clinical reports purporting to assess mortality among monitored infants. The data from these studies are invariably presented without appropriate comparison groups. They address (1) apnea with "successful intervention," (2) deaths following apnea where compliance has been questionable, and (3) deaths in spite of appropriate parental response to monitor alarms. Without data on all infants monitored (survivors as well as decedents), these studies are inconclusive and potentially misleading. The ability of care takers to consistently determine the true nature of an alarm from a home monitor is questionable. This poses a problem in assessing effectiveness. Some studies have used parental reports as a means of evaluation. However, one study reported that most alarms reported by parents as truly life-threatening were not.   Based on the Above, What Recommendations Can Be Made at Present Regarding the Circumstances for Use of Home Apnea Monitoring in Infancy? Experience suggests that cardiorespiratory monitoring is effective in preventing death due to apnea for certain selected infants but is clearly inappropriate for others. For some infants, the appropriateness of home monitoring is uncertain. In deciding to monitor or not to monitor, the primary objective is to serve the best interest of the infant and therefore the decision should primarily be based on the infant's history. For example, has the infant had recurrent, severe apnea? For all groups, it should be clearly understood that monitoring cannot guarantee survival. As summarized below, monitoring creates its own risks for infants. Cardiorespiratory monitoring or an alternative therapy is medically indicated for certain groups of infants at high risk for sudden death. These groups include infants with one or more severe ALTE's requiring mouth-to-mouth resuscitation or vigorous stimulation, symptomatic preterm infants, siblings of two or more SIDS victims, and infants with certain diseases or conditions such as central hypoventilation. Although no controlled clinical trials have rigorously proved monitoring to be effective in these groups, evidence indicates that these infants are at an extraordinarily high risk for dying and that lives can be saved. Alternative or ancillary treatments such as methylxanthines and/or hospitalization may be considered for specific infants. Cardiorespiratory monitoring is not medically indicated for normal infants. SIDS occurs at a rate of approximately 2 per 1,000 live births in the United States. For the normal newborn, the risks, disadvantages, and costs of monitoring outweigh the possible benefit of preventing SIDS. Routine monitoring of asymptomatic preterm infants, as a group, is not warranted. Individual preterm infants such as those with certain residual diseases may be considered for monitoring. For several groups, currently available evidence on the benefits and risks of monitoring and alternative treatment is inconclusive. These groups include siblings of SIDS infants, infants with less severe ALTE episodes, infants with tracheostomies, and infants of opiate- or cocaine-abusing mothers. For each of these groups, the risk of death is elevated to some degree. For infants in this category, the decision to monitor must be made by the family after a full discussion with the physician of the potential benefits as well as the psychosocial burdens. The decision reached will be specific to the infant, and there are no hard and fast guidelines that will apply to all cases. No family in this category should be made to feel that monitoring is necessary. The pneumogram should not be used as a screening tool. Pneumograms have been widely used as screening tests to predict SIDS or life-threatening apnea in asymptomatic preterm and term infants. However, no prospective controlled study has confirmed that these 12- to 24-hour recordings of heart rate and thoracic impedance are predictive of SIDS or life-threatening apnea. In fact, in one study, similar cardiorespiratory recordings on over 9,000 infants have not demonstrated differences between subsequent SIDS victims and surviving infants. In premature infants, SIDS siblings, or ALTE infants, no studies to date have proved that the pneumogram has predictive value that distinguishes infants who will survive from those who will die. However, pneumograms occasionally may be helpful in clinical management. For instance, pneumograms may be used to distinguish false from true apnea monitor alarms. Decisions to discontinue home monitoring should be based on clinical criteria. The criteria for monitor discontinuation should be based on the infant's clinical condition. Clinical experience and the literature support monitor discontinuation when ALTE infants have had 2 to 3 months free of significant alarms or apnea (vigorous stimulation or resuscitation was not needed). Additionally, assessing the infant's ability to tolerate stress (e.g., immunizations, illnesses) during this time is advisable. Requiring one or more normal pneumograms before discontinuing the monitor may prolong needlessly the monitoring period. Decision making about home monitoring is a collaborative enterprise. When a clinician has determined that clinical indications justify the use of a home monitor, the clinician must seek the cooperation and permission of the parent or guardian of the infant to be monitored. Parents, acting as proxies for their infant, and clinicians should attempt to reach a joint decision on whether home monitoring should be undertaken. The physician should disclose the available information on alternative treatments, benefits, and limitations of the monitors. Understanding the impact of monitoring on the family should be a central consideration in the decision. The literature on the effects of monitoring in families has serious flaws, but it suggests that monitoring can be both a source of stress and a source of support and reassurance for parents. Some of the stresses parents report are related to monitor equipment problems, isolation, the extra demands and responsibility of caring for a monitored infant, the cost of monitoring, difficulty in finding child care, sibling rivalry, depression, and marital strains. Parents also report that home monitoring can be reassuring for those whose infants are judged to be at medical risk. In discussing these substantive matters with parents, a good faith effort should be made to take into account the values and the social and economic circumstances of the parents in so far as they are relevant to the alternative selected. The possibility of economic benefit to providers should not materially affect decisions to test or monitor infants. Individuals and institutions should be aware of potential financial conflicts of interest and make appropriate disclosures. Finally, institutions and clinicians might find it useful to relay the information in writing after the discussion of these matters to ensure understanding of and consistency in the information conveyed. Ordinarily, parents and clinicians will agree about whether to use the monitor. However, there will be some instances of disagreement. When the clinician concludes that cardiorespiratory monitoring is medically indicated and the parents disagree, the clinician has several options. The clinician may defer to parental preferences, continue hospitalization, seek suitable assistance and support to facilitate monitoring, and, in the rare case, initiate procedures to remove the infant from the home. Such decisions should be reached on a case-by-case basis, taking into account factors specific to the situation, including the medical needs of the infant, the home environment, and the expectation that, on balance, a better outcome is likely in another caregiving environment. When cardiorespiratory monitoring is not indicated (see above), clinicians are encouraged not to prescribe monitors when they are requested by parents. When evidence on the benefits and risks of monitoring or alternative treatments is inconclusive and there is disagreement, the decision whether to use a monitor should be left to the parents. Deferring to parental choice is appropriate because the parents are the ones who have to implement the decision and take primary responsibility for its consequences. An adequate monitoring support system encompasses medical, technical, psychosocial, and community support services. This coordinated, multidisciplinary approach can include hospital-based monitoring programs, community-based physicians, health care agencies, durable medical equipment vendors, local public health and social service agencies, and peer or voluntary support groups. In the hospital, the support system includes: (1) an informed consent process; (2) an assessment of the family's strengths, weaknesses, and support resources; (3) anticipatory guidance to help prepare the family for the demands of home monitoring; (4) a thorough explanation of monitor operation, trouble-shooting, and a written monitor service contract; (5) training and demonstrated proficiency in infant CPR and resuscitation methods; (6) written guidelines on home monitoring; and (7) discharge planning, including discussion of followup services and procedures for discontinuation. After discharge, formal and regular followup contact with the family should be maintained. Consultant and primary care physicians must coordinate their activities. There should be 24-hour availability of monitor program support staff and monitor repair or replacement. Access to psychosocial support mechanisms, including community social services such as public health nurses and social workers, peer support, and respite care, should be provided. Extra assistance at the time of monitor termination should be available. Effective monitor use is dependent on the technical support network outside the home. A formal support system for users includes mechanisms for quality assurance, maintenance service and replacement, and education and users manuals for parents and physicians on monitor operation and maintenance. In addition, means for communication about machine problems among manufacturers, parents, physicians, and vendors are essential to ensure the safety of the apnea monitor in the home. It is important to emphasize that home monitoring is not one but a cluster of interrelated services.   What Further Research Is Needed on Home Apnea Monitoring for Infants? There should be definitive prospective studies involving randomization and concurrent control populations of issues involved in home monitoring for apnea. Unless studies are conducted soon, we may lose the opportunity and pay a price in unforeseen and untoward outcomes. The fact that controversy exists regarding home apnea monitoring reflects an inadequate fund of knowledge. This was constantly brought up in testimony at the conference as well as in the deliberations of the panel. From the perspective of advancing SIDS research, it is important to focus on those infants dying of SIDS. For clinicians, however, it is important to look carefully at all of these infants who die suddenly and unexpectedly of any cause (e.g., from aspiration pneumonia, upper airway obstruction, chronic lung disease). Many such deaths are potentially preventable, although they should not be called SIDS. Sudden death, including SIDS, is a major part of all postneonatal infant deaths. Furthermore, there may be multiple causes of SIDS. Therefore, the panel makes the following general recommendation: All sudden death in infants, not only sudden infant death syndrome, should receive high priority in future research initiatives. The hypothesis that apnea is the major cause of sudden death has not been substantiated, yet many clinical and research efforts are proceeding with acceptance of this hypothesis. These efforts should proceed with the realization that causality is unclear. In addition: The apnea hypothesis should be further tested. Causal hypotheses for SIDS other than apnea should receive more attention. Research related to five substantive areas considered by the panel might include the following: Apnea A prospective controlled study of the use of monitoring in specific populations that may be at risk, including infants with apnea of prematurity, apnea of infancy, and other conditions such as bronchopulmonary dysplasia and maternal exposure to drugs, is indicated. The following questions should be addressed: Are there clinical markers for infants at high risk for ALTE and sudden death (including SIDS)? Will monitoring reduce the incidence of mortality in these infants? Will monitoring influence morbidity of these infants? Are there adverse consequences of monitoring? Continued efforts to elucidate basic pathophysiology of apnea of prematurity and apnea of infancy are important. Identification of risk assessment methods and pharmacologic treatments and their use in conjunction with monitors should be pursued.   Monitoring: Technical New methods of sensing infant breathing need to be developed and evaluated. Particular attention needs to be paid to nonimpedance types of sensors that are suitable for home use, the simultaneous recording of several sensors, and signal processing that make apnea detection more efficacious. The use of heart rate monitors needs further investigation. Studies must be designed to determine if heart rate monitors are adequate for detecting and alarming on life-threatening events. The use of pulse oximetry for infant apnea monitoring needs further investigation. Reliable, less expensive instrumentation appropriate for home use should be developed, and the usefulness of this measurement for hypoxemia detection needs to be determined. The use of hard copy recordings of this variable along with respiration and heart rate must also be evaluated. Infant monitors, no matter what type, need to be more reliable. Monitors with improved self-testing algorithms must be developed, and standards and methods of signal simulation and testing must be established. Studies that determine the optimal means of quality assurance, trouble-shooting, and service (i.e., support) for home apnea monitors are needed.   Monitoring: Psychosocial Research to identify the psychosocial characteristics and apnea program operational procedures that help families adapt, cope with, and use home monitors effectively needs to be undertaken. Short- and long-term effects of monitoring on infants, parents, siblings, parent-child interactions, and families should be investigated. The hypothesis of a relationship between monitoring and child abuse needs further study. Studies to establish the rates, causes, and consequences of noncompliance and premature termination of monitoring should receive high priority. Research to identify factors related to and interventions promoting the ability of families to terminate monitoring would be of benefit.   Apnea Program: Health Services Identification of ways of assuring access to assessment, monitoring, and coordinated medical, technical, psychosocial, and community support services for infants at risk should be a priority of regional, state, and Federal authorities. Development and coordination of appropriate regional patterns of care, including the identification of the role of the referral center, community hospital, primary care physician, community agencies, and informal supports, should be pursued further. The components, organizations, and relative value of community supports that are necessary to minimize family stress and promote effective monitoring should be better delineated.   Sudden Death, Including SIDS Comparative epidemiologic studies of apnea of infancy, ALTE, and sudden death should receive high priority. New and improved technologies or markers with predictive value for prospective identification of infants destined to develop ALTE (including apnea of infancy) and SIDS need to be identified. The possibility that tissue specimens can be utilized to identify subsets of the SIDS group and that a national SIDS tissue bank would be worthwhile should be evaluated. The possibility that methodologies such as intense psychosocial support and other interventions might be more effective than monitoring in mortality prevention needs further study. Conclusion This statement summarizes a consensus process devoted to questions focusing on infantile apnea and home monitoring. The level of concern is high, the need for definition and knowledge helpful to the clinician is evident, and the overall fund of knowledge is inadequate. The relation of neonatal and infant apnea is that of two apparently separate problems, each with an unclear relationship to mortality and morbidity in infancy. Presently available devices appear to be safe, but their efficacy needs additional study, and technology needs to be advanced. Beneficial and adverse effects of monitoring are evident but need further study. The need for adequate support systems is apparent. The effectiveness of home monitoring in reducing infant mortality and morbidity is not yet established. Additional studies need to be done. A recommendation to monitor selected high-risk infants is made. Routine monitoring or screening of normal term or preterm infants is not recommended. There are certain patients for whom evidence is inconclusive and decisions will have to be individualized. Recommendations for future research of a general and specific nature are made.   Consensus Development Panel George A. Little, M.D. Panel Chairperson Professor and Chairman Department of Maternal and Child Health Dartmouth-Hitchcock Medical Center Hanover, New Hampshire Roberta A. Ballard, M.D. Director Maternal and Child Health Services Mount Zion Hospital and Medical Center Adjunct Associate Professor of Pediatrics University of California at San Francisco San Francisco, California John G. Brooks, M.D. Associate Professor of Pediatrics University of Rochester School of Medicine and Dentistry Rochester, New York Robert T. Brouillette, M.D. Associate Professor of Pediatrics Northwestern University Medical School Associate Director Sleep Laboratory Attending Neonatologist Children's Memorial Hospital Chicago, Illinois Larry Culpepper, M.D. Associate Professor of Family Medicine Brown University The Memorial Hospital of Rhode Island Pawtucket, Rhode Island Herman B. Gray, Jr., M.D. Medical Director Apnea Identification Program Wayne County SIDS Center Children's Hospital of Michigan Detroit, Michigan Patricia King, J.D. Associate Professor Georgetown University Law Center Washington, D.C. Marvin O. Kolb, M.D., F.A.A.P. Department of Pediatrics Fargo Clinic, Ltd. Fargo, North Dakota Ann Neale, Ph.D. Vice President Bon Secours Health System Columbia, Maryland Michael R. Neuman, M.D., Ph.D. Associate Professor of Biomedical Engineering in Reproductive Biology Case Western Reserve University Cleveland, Ohio Donald R. Peterson, M.D., M.P.H. Professor Emeritus University of Washington Seattle, Washington Stuart O. Schweitzer, Ph.D. Professor University of California at Los Angeles School of Public Health Los Angeles, California Heather Weiss, Ed.D. Director Harvard Family Research Project Harvard University Graduate School of Education Cambridge, Massachusetts Speakers Ronald L. Ariagno, M.D. "Experience With Treatment of Apnea in the Intensive Care Nursery Graduate (Stanford University Medical Center)" Associate Professor of Pediatrics Department of Pediatrics Stanford University School of Medicine Stanford, California J. Bruce Beckwith, M.D., D.Sc. "SIDS and Recurring Infantile Apnea: A Pathologist's Perspective" Chairman Department of Pathology Children's Hospital Denver, Colorado Sally L. Davidson Ward, M.D. "SIDS in Infants Evaluated by Apnea Programs in California" Assistant Professor of Pediatrics Children's Hospital of Los Angeles University of Southern California School of Medicine Los Angeles, California Nora Davis, M.D. "Epidemiologic Comparisons of SIDS With Infantile Apnea" Associate Clinical Professor Department of Pediatrics University of Washington Director Apnea Program Children's Hospital Seattle, Washington Carl E. Hunt, M.D. "Experience With Treatment of Apnea (Children's Memorial Hospital, Northwestern University Medical School" Professor and Vice Chairman Department of Pediatrics Children's Memorial Hospital Northwestern University Medical School Chicago, Illinois Lorentz M. Irgens, M.D. "SIDS and Risks of Subsequent Siblings in Norway" Associate Professor Medical Birth Registry of Norway University of Bergen NORWAY Prof. Petter Karlberg "SIDS, SIDS Sibling Mortality, and Near-Miss SIDS in Sweden" Professor of Pediatrics Department of Pediatrics I East Hospital University of Goteborg Goteborg SWEDEN Ehud Krongrad, M.D. "Experience With Treatment of Apnea at Selected Centers" Associate Professor of Pediatrics Columbia University New York, New York David P. Southall, M.D., M.R.C.P. "Detection of Infants at Risk for Infantile Apnea in the United Kingdom: Investigations Into the Relationship between Apnea and Sudden Infant Death" Senior Lecturer in Pediatrics Cardiothoracic Institute Brompton Hospital London ENGLAND Alan R. Spitzer, M.D. "Current Management of Infant Apnea (Children's Hospital of Philadelphia)" Assistant Professor of Pediatrics and Obstetrics and Gynecology University of Pennsylvania Children's Hospital of Philadelphia Philadelphia, Pennsylvania Alfred Steinschneider, M.D., Ph.D. "Breathing and SIDS" President American SIDS Institute Atlanta, Georgia Denise J. Strieder, M.D. "Outcome of Infantile Apnea Management at the Massachusetts General Hospital" Associate Professor of Pediatrics Harvard Medical School Pediatric Pulmonary Laboratory Massachusetts General Hospital Boston, Massachusetts Presenting for T. Allen Merritt, M.D.; Penny Williamson, Sc.D. Executive Vice President National SIDS Foundation Landover, Maryland Planning Committee Duane Alexander, M.D. Planning Committee Chairperson Director National Institute of Child Health and Human Development National Institutes of Health Bethesda, Maryland Heinz W. Berendes, M.D., M.H.S. Director Epidemiology and Biometry Research Program National Institute of Child Health and Human Development National Institutes of Health Bethesda, Maryland Michael J. Bernstein Director of Communications Office of Medical Applications of Research National Institutes of Health Bethesda, Maryland Charlotte Catz, M.D. Chief Pregnancy and Perinatology Branch National Institute of Child Health and Human Development National Institutes of Health Bethesda, Maryland Susan M. Clark Social Science Analyst Office of Medical Applications of Research National Institutes of Health Bethesda, Maryland Marlene E. Haffner, M.D. Director Office of Health Affairs Department of Health and Human Services Food and Drug Administration Silver Spring, Maryland James G. Hill Chief Office of Planning and Evaluation National Institute of Child Health and Human Development National Institutes of Health Bethesda, Maryland Itzhak Jacoby, Ph.D. Acting Director Office of Medical Applications of Research National Institutes of Health Bethesda, Maryland Samuel Kessel, M.D. Chief Research and Training Branch Division of Maternal and Child Health Department of Health and Human Services Rockville, Maryland James Kiley, Ph.D. Health Scientist Administrator Division of Lung Diseases National Heart, Lung, and Blood Institute National Institutes of Health Bethesda, Maryland George A. Little, M.D. Consensus Panel Chairman Professor and Chairman Department of Maternal and Child Health Dartmouth Medical School Hanover, New Hampshire Col. John R. Pierce, M.D. Assistant Chief Department of Pediatrics Walter Reed Army Medical Hospital Washington, D.C. Michaela P. Richardson Chief Office of Research and Reporting National Institute of Child Health and Human Development National Institutes of Health Bethesda, Maryland Jonelle C. Rowe, M.D. Associate Professor Department of Pediatrics Division of Neonatology University of Connecticut Health Center Farmington, Connecticut Sumner J. Yaffe, M.D. Director Center for Research for Mothers and Children National Institute of Child Health and Human Development National Institutes of Health Bethesda, Maryland Conference Sponsors National Institute of Child Health and Human Development Duane Alexander, M.D. Director National Heart, Lung, and Blood Institute Claude Lenfant, M.D. Director Division of Maternal and Child Health, Health Resources and Services Administration Vince Hutchins, M.D. Director Food and Drug Administration Frank E. Young, M.D. Commissioner NIH Office of Medical Applications of Research Itzhak Jacoby, Ph.D. Acting Director

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