Treatment decisions for the extremely premature infant

Abstract

See related articles, p 608 and p 616.The gestational age at which a newborn has a 50/50 chance of surviving has been dropping steadily from about 30 to 31 weeks in the 1960s1Congress US Neonatal intensive care for low birthweight infants: costs and effectiveness. Health Technology Case Study No. 38. Office of Technology Assessment, Washington (DC)December 1987Google Scholar to 24 weeks in the 1990s at leading centers.2Lorenz JM. Survival of the extremely preterm infant in North America in the 1990s.Clin Perinatol. 2000; 27: 255-262Abstract Full Text Full Text PDF PubMed Scopus (87) Google Scholar Until very recently, survival at 23 weeks, even in major centers, was closer to 20%.2Lorenz JM. Survival of the extremely preterm infant in North America in the 1990s.Clin Perinatol. 2000; 27: 255-262Abstract Full Text Full Text PDF PubMed Scopus (87) Google Scholar However, with aggressive intrapartum and neonatal care, a survival rate of 41% at 23 weeks was reported in one 1998 study,3Batton DG DeWitte DB Espinosa R Swails TL. The impact of fetal compromise on outcome at the border of viability.Am J Obstet Gynecol. 1998; 178: 909-915Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar and in this issue of The Journal, El-Metwally et al4El-Metwally D Vohr B Tucker R. Survival and neonatal morbidity at the limits of viability in the mid 1990s: 22 to 25 weeks.J Pediatr. 2000; 137: 616-622Abstract Full Text Full Text PDF PubMed Scopus (163) Google Scholar report a survival rate among live births of 46% at 23 weeks. In this latter study, from Women and Infants’ Hospital in Providence, Rhode Island, the babies were relatively unselected, cases of triploidy and major malformations were not excluded, and surveillance began in labor, ensuring that delivery room deaths were included in the neonatal mortality count.5Hack M Fanaroff AA. Changes in the delivery room care of the extremely small infant (less than 750 g). Effects on morbidity and outcome.N Engl J Med. 1986; 314: 660-664Crossref PubMed Scopus (75) Google Scholar This article is one of just a few reports that describe in detail the obstetric and neonatal management that patients received. Close intrapartum monitoring was used, antenatal steroids were administered, a neonatologist attended all deliveries, resuscitation with bag and mask and intubation was initiated in all infants with a detectable heart rate, and all resuscitated infants were admitted to the neonatal intensive care unit where they were stabilized and given surfactant prophylactically. The only relevant information not provided was the number of infants from whom intensive care was withdrawn notwithstanding the potential for survival. It now appears that provision of aggressive intensive care by experienced and well-staffed maternal-fetal and neonatal services can lead to survival at 23 weeks approaching 50%.At such survival rates, long-term outcomes and their associated costs will play a large role for some in decisions as to whether to institute intensive care in infants born as early as 23 weeks. Long-term outcomes are not yet available for the Providence cohort, but short-term correlates of neurodevelopmental outcome—grades of hemorrhage that correspond to white matter damage, periventricular leukomalacia, chronic lung disease, and necrotizing enterocolitis6Vohr BR Wright LL Dusick AM Mele L Verter J Steichen JJ et al.Neurodevelopmental and functional outcomes of extremely low birth weight infants in the National Institute of Child Health and Human Development Neonatal Research Network, 1993-1994.Pediatrics. 2000; 105: 1216-1226Crossref PubMed Scopus (964) Google Scholar—were all at least twice as prevalent at 23 weeks as at 24 and 25 weeks. In light of these findings, a greater prevalence of major neurodevelopmental disability in later childhood can be anticipated. Mean number of days on which a ventilator was needed and length of stay (and therefore cost of care) were also greater at 23 weeks than at 24 to 25 weeks in this study. In reviewing the literature describing outcomes in extremely premature infants, we have found a suggestion of a progressive increase in the prevalence of major disability as gestational age decreases, from 20% at 26 weeks to 40% at 23 weeks (unpublished data).The potential for saving the lives of as many as half of all babies born alive at 23 weeks is now established. But who should decide whether intensive care is initiated for infants of this gestational age?De Leeuw et al,7de Leeuw R Cuttini M Nadai M Berbik I Hansen G Kucinskas A et al.Treatment choices for extremely preterm infants: an international perspective.J Pediatr. 2000; 137: 608-615Abstract Full Text Full Text PDF PubMed Scopus (208) Google Scholar in this issue of The Journal, report the results of the first systematic international survey of approaches to care of the extremely premature newborn. This article is from the EURONIC (Ethical Decision-Making in Neonatal Intensive Care) Project, a collaboration of 11 European countries whose purpose is to examine decision making in a sample of newborn intensive care units in Europe.8Cuttini M Kaminiski M Saracci R Vonderweid U. The EURONIC Project: a European concerted action on information to parents and ethical decision-making in neonatal intensive care.Paediatr Perinatal Epidemiol. 1997; 11: 461-474Crossref PubMed Scopus (51) Google Scholar A previous article by the EURONIC Project provided a review of legislation and guidelines regarding the provision of care to extremely premature infants in Europe,9McHaffie HE Cuttini M Brolz-Voit Z Randag L Mousty R Duguet AM et al.Withholding/withdrawing treatment from neonates: legislation and guidelines across Europe.J Med Ethics. 1999; 25: 440-446Crossref PubMed Scopus (94) Google Scholar and another article described the self-reported experiences of physicians in withholding and withdrawing care.10Cuttini M Nadia M Kaminski M Hansen G de Leeuw R Lenoir S et al.End-of life decisions in neonatal intensive care: physician’ self-reported practices in seven European countries.Lancet. 2000; 355: 2112-2118Abstract Full Text Full Text PDF PubMed Scopus (324) Google Scholar In the study reported in this issue of The Journal, neonatologists in Italy, France, Spain, Germany, the Netherlands, Luxembourg, Great Britain, Sweden, Hungary, Estonia, and Lithuania were surveyed to explore management strategies for a paradigmatic case of a 560-g, 24 weeks’ gestation newborn with a 1-minute Apgar score of 1; a few days after birth the infant develops seizures, a massive unilateral hemorrhage with ventricular dilatation, and periventricular parenchymal involvement. A striking range of approaches to managing this case was found. The majority of physicians in every country but the Netherlands reported that they would initiate intensive care. In Italy, Hungary, and Estonia, half or nearly half of physicians would do so, even if later withdrawal of intensive care were not an option. In the remaining countries, the majority of physicians would initiate intensive care, were there an option to later withdraw that care. Among physicians who would initiate intensive care, only in the Netherlands, Great Britain, and Lithuania would parental opposition alter the decision of more than a quarter of respondents.With subsequent neurologic deterioration, more variation in approach was found both among and within countries. However, in no country would the majority of physicians continue full intensive care without involving the parents; nevertheless, very few physicians who favored continuing care after neurologic deterioration would change their course of action even if the parents opposed it. On the other hand, many physicians who favored limiting or discontinuing care would reverse that decision in the face of parental opposition. In France, a small majority of physicians would limit or withdraw intensive care without involving the parents in the decision. Although nationality was the strongest determinant of approaches to this hypothetical infant’s care, even after adjustment for potentially confounding variables, significant variation was found within countries. Characteristics such as sex of the physician, years of experience, religion, and parenthood were significantly related to management approaches.The responses of physicians in this survey might be functions of their clinical experience, their values, their perceptions of prognosis for the infant described, or combinations of all of these. These responses imply marked variation in practice, which translates into substantial variation in the options available to parents. Although no data comparable to those of de Leeuw et al7de Leeuw R Cuttini M Nadai M Berbik I Hansen G Kucinskas A et al.Treatment choices for extremely preterm infants: an international perspective.J Pediatr. 2000; 137: 608-615Abstract Full Text Full Text PDF PubMed Scopus (208) Google Scholar are available for neonatologists in North America, anecdotal experience suggests that a wide range of approaches is likely to be found here as well.Such variation in practice may seem understandable in light of the complexities of balancing the risks and benefits of the provision of intrapartum and neonatal care to mother and baby, the chances of survival, and the potential long-term burdens, while at the same time considering parental autonomy, parental values, the values of the larger community, and the consumption of limited resources. But although understandable, can such variation in the range of options available to parents within a country or a community be ethically justified ?It is our view that extremely premature infants fall into one of three categories: those that nearly everyone agrees should be treated; those that nearly everyone agrees should not be treated; and those in a middle (optional intensive care) zone, where disagreement about the appropriateness of intensive care is both ethical and legitimate. The wide range of views obtained in the EURONIC survey indicates that the paradigmatic infant fits into this middle zone, at least for the respondents to this survey considered as a whole. The survey also reveals that the personal views of physicians play a large role in decision making when the provision of intensive care is optional. We believe that in this optional care zone, parents should be actively involved in decision making after being informed by their physicians of the best available information about survival and prognosis. The physician’s personal choices should not be determining factors.It is, of course, difficult to know where to draw the boundaries of these zones. This judgment should not be made in private; it is a fundamentally social judgment, because it involves the interests and rights of others. Fairness and justice dictate that these boundary issues should be determined at the level of the relevant community. Unfortunately, it is difficult to identify and engage a reasonable representation of the “relevant” community. Moreover, processes by which representatives of the relevant community can come to consensus about a range of acceptable options of care, such as rational democratic deliberation,11Fleck LM. Just caring: Oregon, health care rationing, and informed democratic deliberation.J Med Philos. 1994; 19: 367-388Crossref PubMed Scopus (41) Google Scholar require a great deal of planning, effort, and time to make them operational at the community level. In Wisconsin, however, representatives of the community have been able to develop “Guidelines for the Responsible Use of Intensive Care,” a document that defines these boundaries explicitly.12Lawrence University Program in Biomedical Ethics and Wisconsin Health Decisions Guidelines for the responsible use of intensive care. Lawrence University, Appleton (WI)1998Google Scholar Guidelines must not compel all physicians to participate in all care decisions that are acceptable to the larger community; but, at the same time, the physician should not limit (or expand) the range of options that is acceptable within the community. Absent such guidelines, the individual physician must try to ascertain what options are acceptable to the portions of the community with which he or she is in touch and avoid imposing his or her own values on the family. See related articles, p 608 and p 616. The gestational age at which a newborn has a 50/50 chance of surviving has been dropping steadily from about 30 to 31 weeks in the 1960s1Congress US Neonatal intensive care for low birthweight infants: costs and effectiveness. Health Technology Case Study No. 38. Office of Technology Assessment, Washington (DC)December 1987Google Scholar to 24 weeks in the 1990s at leading centers.2Lorenz JM. Survival of the extremely preterm infant in North America in the 1990s.Clin Perinatol. 2000; 27: 255-262Abstract Full Text Full Text PDF PubMed Scopus (87) Google Scholar Until very recently, survival at 23 weeks, even in major centers, was closer to 20%.2Lorenz JM. Survival of the extremely preterm infant in North America in the 1990s.Clin Perinatol. 2000; 27: 255-262Abstract Full Text Full Text PDF PubMed Scopus (87) Google Scholar However, with aggressive intrapartum and neonatal care, a survival rate of 41% at 23 weeks was reported in one 1998 study,3Batton DG DeWitte DB Espinosa R Swails TL. The impact of fetal compromise on outcome at the border of viability.Am J Obstet Gynecol. 1998; 178: 909-915Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar and in this issue of The Journal, El-Metwally et al4El-Metwally D Vohr B Tucker R. Survival and neonatal morbidity at the limits of viability in the mid 1990s: 22 to 25 weeks.J Pediatr. 2000; 137: 616-622Abstract Full Text Full Text PDF PubMed Scopus (163) Google Scholar report a survival rate among live births of 46% at 23 weeks. In this latter study, from Women and Infants’ Hospital in Providence, Rhode Island, the babies were relatively unselected, cases of triploidy and major malformations were not excluded, and surveillance began in labor, ensuring that delivery room deaths were included in the neonatal mortality count.5Hack M Fanaroff AA. Changes in the delivery room care of the extremely small infant (less than 750 g). Effects on morbidity and outcome.N Engl J Med. 1986; 314: 660-664Crossref PubMed Scopus (75) Google Scholar This article is one of just a few reports that describe in detail the obstetric and neonatal management that patients received. Close intrapartum monitoring was used, antenatal steroids were administered, a neonatologist attended all deliveries, resuscitation with bag and mask and intubation was initiated in all infants with a detectable heart rate, and all resuscitated infants were admitted to the neonatal intensive care unit where they were stabilized and given surfactant prophylactically. The only relevant information not provided was the number of infants from whom intensive care was withdrawn notwithstanding the potential for survival. It now appears that provision of aggressive intensive care by experienced and well-staffed maternal-fetal and neonatal services can lead to survival at 23 weeks approaching 50%. At such survival rates, long-term outcomes and their associated costs will play a large role for some in decisions as to whether to institute intensive care in infants born as early as 23 weeks. Long-term outcomes are not yet available for the Providence cohort, but short-term correlates of neurodevelopmental outcome—grades of hemorrhage that correspond to white matter damage, periventricular leukomalacia, chronic lung disease, and necrotizing enterocolitis6Vohr BR Wright LL Dusick AM Mele L Verter J Steichen JJ et al.Neurodevelopmental and functional outcomes of extremely low birth weight infants in the National Institute of Child Health and Human Development Neonatal Research Network, 1993-1994.Pediatrics. 2000; 105: 1216-1226Crossref PubMed Scopus (964) Google Scholar—were all at least twice as prevalent at 23 weeks as at 24 and 25 weeks. In light of these findings, a greater prevalence of major neurodevelopmental disability in later childhood can be anticipated. Mean number of days on which a ventilator was needed and length of stay (and therefore cost of care) were also greater at 23 weeks than at 24 to 25 weeks in this study. In reviewing the literature describing outcomes in extremely premature infants, we have found a suggestion of a progressive increase in the prevalence of major disability as gestational age decreases, from 20% at 26 weeks to 40% at 23 weeks (unpublished data). The potential for saving the lives of as many as half of all babies born alive at 23 weeks is now established. But who should decide whether intensive care is initiated for infants of this gestational age? De Leeuw et al,7de Leeuw R Cuttini M Nadai M Berbik I Hansen G Kucinskas A et al.Treatment choices for extremely preterm infants: an international perspective.J Pediatr. 2000; 137: 608-615Abstract Full Text Full Text PDF PubMed Scopus (208) Google Scholar in this issue of The Journal, report the results of the first systematic international survey of approaches to care of the extremely premature newborn. This article is from the EURONIC (Ethical Decision-Making in Neonatal Intensive Care) Project, a collaboration of 11 European countries whose purpose is to examine decision making in a sample of newborn intensive care units in Europe.8Cuttini M Kaminiski M Saracci R Vonderweid U. The EURONIC Project: a European concerted action on information to parents and ethical decision-making in neonatal intensive care.Paediatr Perinatal Epidemiol. 1997; 11: 461-474Crossref PubMed Scopus (51) Google Scholar A previous article by the EURONIC Project provided a review of legislation and guidelines regarding the provision of care to extremely premature infants in Europe,9McHaffie HE Cuttini M Brolz-Voit Z Randag L Mousty R Duguet AM et al.Withholding/withdrawing treatment from neonates: legislation and guidelines across Europe.J Med Ethics. 1999; 25: 440-446Crossref PubMed Scopus (94) Google Scholar and another article described the self-reported experiences of physicians in withholding and withdrawing care.10Cuttini M Nadia M Kaminski M Hansen G de Leeuw R Lenoir S et al.End-of life decisions in neonatal intensive care: physician’ self-reported practices in seven European countries.Lancet. 2000; 355: 2112-2118Abstract Full Text Full Text PDF PubMed Scopus (324) Google Scholar In the study reported in this issue of The Journal, neonatologists in Italy, France, Spain, Germany, the Netherlands, Luxembourg, Great Britain, Sweden, Hungary, Estonia, and Lithuania were surveyed to explore management strategies for a paradigmatic case of a 560-g, 24 weeks’ gestation newborn with a 1-minute Apgar score of 1; a few days after birth the infant develops seizures, a massive unilateral hemorrhage with ventricular dilatation, and periventricular parenchymal involvement. A striking range of approaches to managing this case was found. The majority of physicians in every country but the Netherlands reported that they would initiate intensive care. In Italy, Hungary, and Estonia, half or nearly half of physicians would do so, even if later withdrawal of intensive care were not an option. In the remaining countries, the majority of physicians would initiate intensive care, were there an option to later withdraw that care. Among physicians who would initiate intensive care, only in the Netherlands, Great Britain, and Lithuania would parental opposition alter the decision of more than a quarter of respondents. With subsequent neurologic deterioration, more variation in approach was found both among and within countries. However, in no country would the majority of physicians continue full intensive care without involving the parents; nevertheless, very few physicians who favored continuing care after neurologic deterioration would change their course of action even if the parents opposed it. On the other hand, many physicians who favored limiting or discontinuing care would reverse that decision in the face of parental opposition. In France, a small majority of physicians would limit or withdraw intensive care without involving the parents in the decision. Although nationality was the strongest determinant of approaches to this hypothetical infant’s care, even after adjustment for potentially confounding variables, significant variation was found within countries. Characteristics such as sex of the physician, years of experience, religion, and parenthood were significantly related to management approaches. The responses of physicians in this survey might be functions of their clinical experience, their values, their perceptions of prognosis for the infant described, or combinations of all of these. These responses imply marked variation in practice, which translates into substantial variation in the options available to parents. Although no data comparable to those of de Leeuw et al7de Leeuw R Cuttini M Nadai M Berbik I Hansen G Kucinskas A et al.Treatment choices for extremely preterm infants: an international perspective.J Pediatr. 2000; 137: 608-615Abstract Full Text Full Text PDF PubMed Scopus (208) Google Scholar are available for neonatologists in North America, anecdotal experience suggests that a wide range of approaches is likely to be found here as well. Such variation in practice may seem understandable in light of the complexities of balancing the risks and benefits of the provision of intrapartum and neonatal care to mother and baby, the chances of survival, and the potential long-term burdens, while at the same time considering parental autonomy, parental values, the values of the larger community, and the consumption of limited resources. But although understandable, can such variation in the range of options available to parents within a country or a community be ethically justified ? It is our view that extremely premature infants fall into one of three categories: those that nearly everyone agrees should be treated; those that nearly everyone agrees should not be treated; and those in a middle (optional intensive care) zone, where disagreement about the appropriateness of intensive care is both ethical and legitimate. The wide range of views obtained in the EURONIC survey indicates that the paradigmatic infant fits into this middle zone, at least for the respondents to this survey considered as a whole. The survey also reveals that the personal views of physicians play a large role in decision making when the provision of intensive care is optional. We believe that in this optional care zone, parents should be actively involved in decision making after being informed by their physicians of the best available information about survival and prognosis. The physician’s personal choices should not be determining factors. It is, of course, difficult to know where to draw the boundaries of these zones. This judgment should not be made in private; it is a fundamentally social judgment, because it involves the interests and rights of others. Fairness and justice dictate that these boundary issues should be determined at the level of the relevant community. Unfortunately, it is difficult to identify and engage a reasonable representation of the “relevant” community. Moreover, processes by which representatives of the relevant community can come to consensus about a range of acceptable options of care, such as rational democratic deliberation,11Fleck LM. Just caring: Oregon, health care rationing, and informed democratic deliberation.J Med Philos. 1994; 19: 367-388Crossref PubMed Scopus (41) Google Scholar require a great deal of planning, effort, and time to make them operational at the community level. In Wisconsin, however, representatives of the community have been able to develop “Guidelines for the Responsible Use of Intensive Care,” a document that defines these boundaries explicitly.12Lawrence University Program in Biomedical Ethics and Wisconsin Health Decisions Guidelines for the responsible use of intensive care. Lawrence University, Appleton (WI)1998Google Scholar Guidelines must not compel all physicians to participate in all care decisions that are acceptable to the larger community; but, at the same time, the physician should not limit (or expand) the range of options that is acceptable within the community. Absent such guidelines, the individual physician must try to ascertain what options are acceptable to the portions of the community with which he or she is in touch and avoid imposing his or her own values on the family. Treatment choices for extremely preterm infants: An international perspectiveThe Journal of PediatricsVol. 137Issue 5PreviewObjective: To compare treatment choices of neonatal physicians and nurses in 11 European countries for a hypothetical case of extreme prematurity (24 weeks’ gestational age, birth weight of 560 g, Apgar score of 1 at 1 minute). Study design: An anonymous, self-administered questionnaire was completed by 1401 physicians (response rate, 89%) and 3425 nurses (response rate, 86%) from a large, representative sample of 143 European neonatal intensive care units. Italy, Spain, France, Germany, the Netherlands, Luxembourg, Great Britain, Sweden, Hungary, Estonia, and Lithuania participated. Full-Text PDF Survival and neonatal morbidity at the limits of viability in the mid 1990s: 22 to 25 weeksThe Journal of PediatricsVol. 137Issue 5PreviewObjective: We determined neonatal survival and morbidity rates based on both fetal (stillborn) and neonatal deaths for infants delivered at 22 to 25 weeks’ gestation. Study design: Two hundred seventy-eight deliveries at 22 to 25 weeks’ completed gestation were analyzed by gestational age groups between January 1993 and December 1997. Logistic regression models were used to identify maternal and neonatal factors associated with survival. Results: The rate of fetal death was 24%; 76% of infants were born alive and 46% survived to discharge. Full-Text PDF