Published online December 31, 2007
PEDIATRICS Vol. 121 No. 1 January 2008, pp. e193-e198 (doi:10.1542/10.1542/peds.2007-0513)
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SPECIAL ARTICLE

Perinatal Care at the Threshold of Viability: An International Comparison of Practical Guidelines for the Treatment of Extremely Preterm Births

Maria Serenella Pignotti, MD and Gianpaolo Donzelli, MD

Neonatal Medicine, A. Meyer Children Hospital, University of Florence, Florence, Italy


   ABSTRACT
TOP
 ABSTRACT
METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Over the last 2 decades, the survival rate of infants born at ≤25 weeks of gestation has increased; however, significant morbidity and disability persist. The commitment for their care gives rise to a variety of complex medical, social, and ethical aspects. Decision-making is a crucial issue that involves the infant, the family, health care providers, and society. In a review of the existing guidelines, we investigated the different approaches in the care of extremely preterm births in various countries. We found that many scientific societies and professional organizations have issued guidelines that address the recommendations for the care of these fetuses/neonates although to varying degrees. In this article we compare different approaches and assess the scientific grounds of the specific recommendations. With current standards, intensive care is generally considered justifiable at ≥25 weeks, compassionate care at ≤22 weeks, and an individual approach at 23 to 24 weeks, consistent with the parents' wishes and the infant's clinical conditions at birth.

Key Words: practice guidelines • newborn • withholding treatment • fetal viability • perinatal care

With continual progress in perinatal care, the limit of human viability has moved toward an increasingly younger gestational age. Thanks to modern care standards, the survival rate has risen, although for infants born between 22 and 25 weeks' gestation, it is still very low,1–5 and in our opinion the increased nonimpaired survival demonstrated with aggressive management at 23 to 24 weeks in Norway and Sweden by Markestad et al6 and Serenius et al,7 respectively, does not seem to have a great impact on the ethical dilemma regarding intensive care in these infants. The threshold of human viability seems to be limited to the physiologic development of the lungs that takes place around weeks 22 to 24. Consequently, survival rate at this age is not expected to improve, at least with the current technologic resources.8–10 Moreover, the care of such tiny infants implies a variety of complex medical, social, and economical aspects calling for ethical decisions, because the boundary between utility and futility is not clear. The infant's best interests are far from being understood, and concern surrounding the ethical basis of providing such intensive, multidisciplinary, lifelong care is growing in the scientific world. The majority of these infants will die before, during, or after birth in the NICU.1 For those who survive, there is further risk of death during childhood, and approximately half will suffer from moderate-to-severe neurodevelopmental problems.2 At the age of 6 years, some of those previously believed to be healthy will show some kind of disability.3 To help parents and physicians in the management of an extremely preterm birth, various forms of guidelines have been approved by many scientific societies in different countries. As defined by the Institute of Medicine,11 clinical practice guidelines are "systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances." Their purpose is "to make explicit recommendations with a definitive intent to influence what clinicians do."12 Because of the ongoing discussion about the limit of viability, to compare different approaches, if any, regarding the care of extremely preterm fetuses/neonates, we conducted a search in international literature to investigate the existing guidelines in this field of perinatal care.


   METHODS
TOP
 ABSTRACT
 METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
We searched (2005–2006) Pubmed, Embase, and Google, currently the most-used search engines,13 for practical guidelines on perinatal care at an extremely preterm gestational age using "practice guidelines," "newborn," "withholding treatment," "fetal viability," and "perinatal care" as key words. We also sourced recent issues in relevant international journals and expanded our search by following the references in the articles identified, obtaining specific information from personal knowledge and from referents of specialist perinatal societies of which the names were indicated on Web pages. Local institutional practical guidelines were excluded from the study. The guidelines published by scientific societies were compared. Each document was carefully examined, and specific statements were independently noted and organized into 2 coherent themes: specific treatment suggestions and practical care aspects. Extremely preterm birth was defined in our study as the delivery of a stillborn or a live fetus before 26 completed weeks. Gestational age was defined as the postmenstrual age in weeks and days as per the International Classification of Diseases, 10th Revision.14 The time period between 23 and 23 weeks is referred to as 23 completed weeks of gestation (ie, the infant has completed the 23rd week of gestation and entered the 24th week).


   RESULTS
TOP
 ABSTRACT
 METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
Guidelines for perinatal care at an extremely preterm gestational age have been formulated in different countries over recent years. Fifteen documents were included in our study (Table 1). Practical aspects of care suggested in different countries are illustrated in Table 2.


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  		TABLE 1 Documents Taken Into Account

 

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  		TABLE 2 Practical Aspects of the Care of the Mother and Fetus/Neonate

 
The Canadian Paediatric Society and the Society of Obstetricians and Gynecologists of Canada emphasize15 the need for joint decision-making with fully informed parent and give detailed suggestions for information and the suitability of clinical audits of perinatal death and disability, including long-term outcome. Regular courses are recommended at hospitals in their catchment areas to inform the staff of advances in health care. The American Academy of Pediatrics provides suggestions16 for counseling but fails to give any specific recommendations for treatment stratified on gestational age. However, it does not recommend active intervention for infants under 23 weeks or with 400-g birth weight. The American College of Obstetricians and Gynecologists furnishes recommendations17 split into levels concerning counseling and treatment options: maternal transport to a tertiary center before delivery, an individualized treatment decision of the fetus/newborn, and a single course of corticosteroids between 24 and 34 weeks. In the German document,18 the principle outline states that "if there is any chance, it is necessary to do everything to sustain survival," and regardless of immaturity, every preterm neonate is a candidate for treatment. Below 22 weeks, compassionate care is indicated, although prenatal assessment of gestational age must be confirmed after birth. The German doctors seem to prefer an individual approach as opposed to a statistical approach. In 1998, the National Bioethical Committee in Singapore provided an ethical framework19 outlining the definitions of the treatment dilemma, the infant's best interests, and the identification of high-risk infants including infants <25 weeks of age. While failing to give specific recommendations, they consider it a medical duty, with the parents' consent, to identify infants who could benefit from treatment: if there is good reason to treat, resuscitation is mandatory, otherwise it should be withheld. Active termination of life is strictly prohibited. In the case of uncertain prognosis, provisional intensive care is indicated. Apart from the role of parents and the medical team, they also consider the role of medical ethics committees to provide "ethical comfort" and legal protection for staff. The same concepts have recently been reviewed and analyzed20 by one of the contributors to this document. In 2000, the Federation Nationale des Pediatres Neonatologistes in France drew up general recommendations for perinatal end-of-life decisions21 that provide a framework helping caregivers to arrive at a humane, socially and ethically justifiable decision in the infant's greatest interests while keeping the infant's "quality of life" in mind. They consider the duties of doctors involved in the care of ill newborns, defining particular situations and relative ethical regulations, although they fail to give specific recommendations stratified according to gestational age. The limit of human viability is between 22 and 24 weeks. Between 24 to 26 weeks, survival depends on numerous factors unique to each pregnancy. Caring for neonates can mean withholding or withdrawing life-sustaining treatment and even arresting life. The medical team is responsible for end-of-life decisions after arriving at a collegial agreement and speaking with the parents. The position of the parents seems to be different from the one assumed in other countries: doctors and parents have their own special roles in the care of the newborn, and parents do not ask to be decision-makers if they feel they can trust the doctor. The choice to withhold or withdraw medical treatment must be considered as a new medical decision, a new project for the child, and not simply the decision to do nothing. In the United Kingdom, the British Association of Perinatal Medicine issued a number of practical suggestions in 2000.22 Neonates born between 22 and 28 weeks are within the viability limits, and counseling and involvement of the parents, interaction between senior perinatologists, and follow-up information are all essential for their care. Emphasis is placed on planning and agreement between members of the perinatal team, communication, and the assessment of gestational age. In 2000, the Thames Regional Perinatal Group23 proposed a detailed management approach for infants between 22 and 27 weeks. Resuscitation at ≤22 weeks should be considered experimental. In defining compassionate care, the Thames Regional Perinatal Group refers to the monograph of the Royal College of Pediatrics and Child Health,24 reviewed recently,25 where much emphasis is placed on palliative care. More recently in the United Kingdom, in 2006, the Nuffield Council on Bioethics proposed some week-by-week guidelines26 on when to give intensive care to such infants. They consider the welfare of an infant inextricably linked with the ability of the parents to care for him or her; therefore, the views of the parents are paramount. In the 3 documents from the United Kingdom, active termination of life is not an acceptable choice. In 2002, the Swiss Society of Neonatology published recommendations for the care of infants born between 22 and 26 weeks.27 Care at <24 weeks should generally be limited to palliative care. The administering of intensive care only if a high quality of life is possible could be regarded as discrimination toward the disable. This problem is overcome with "the decision to withhold or withdraw therapies is motivated by the desire to protect the preterm infant from undue suffering and not by the wish to prevent survival with handicaps."27 Life support is continued as long as there is reasonable hope of survival with an acceptable quality of life and if the burden of therapies is endurable for the infant. When this burden outweighs potential benefits, intensive care is no longer justified, and redirection of care to comfort measures could be acceptable. Active termination of life is strictly prohibited. With regard to the parents, the treatment decisions must be developed in an ongoing dialogue among all of the parties involved. The parents should not carry the full responsibility for the decision. The Swiss document also refers to health care resources in that economic considerations should never interfere with an individual case but must have their place at a society level and should refer not simply to economic costs but also to the emotional and physical burden of therapy. In 2003, the Committee for the Ethical Aspects of Human Reproduction and Women's Health of the International Federation of Gynaecologists and Obstetricians28 defined infants between 22 and <28 weeks as having "threshold viability." At this age, it is ethical to institute provisional intensive care at birth until attaining the clinical progress of the infant and consultation between an experienced staff member and the parents clarifies what is best for the child. The Dutch Pediatric Association guidelines, approved in November 2005,29,30 state that at 23 completed weeks, active treatment is not adequate. At 24 weeks, they recommend compassionate family centered care. Admission to the NICU, monitoring, and limited treatment are indicated if the infant is vital, appears older, or if requested by the parents. At 25 weeks, active treatment is recommended with the parents' agreement unless the infant's clinical conditions are severe. Prenatal and postnatal active treatment is recommended at 26 weeks.29,30 Women's Hospitals Australasia is a nonprofit association that advocates the health care needs of women and infants in Australia and New Zealand. It represents many major women's hospitals and health units throughout these countries. In their guidelines,31 they stress the information process, because they consider parental participation in planning and decision-making vital. At 24 to 24 weeks, medical support/surgical support could be indicated. From 24 to 25 weeks, the decision for surgical intervention should be addressed because of its implications for future pregnancies. Several recommendations are reaffirmed by the International Liaison Committee on Resuscitation32 in the international guidelines on neonatal resuscitation. A "do-not-resuscitate" order is an evidence-based justified choice in a newborn of <23 weeks, 400 g, as well as with anencephaly and confirmed trisomy 13 and 18. With an uncertain or inaccurate diagnosis or prognosis, a therapeutic trial with the option of subsequent withdrawal can be considered. In 2004, on reviewing the principles of resuscitation of the newborn,33 the Asociacion Espanola De Pediatria gives advice for the treatment of infants of an extreme gestational age, accepting the statement of the international guidelines mentioned above and published previously.


   DISCUSSION
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
From an international point of view, there is the general agreement that at ≤22 weeks there is no hope of survival for the fetus/neonate. Week 22 to 22 is considered to be the cutoff of human viability: no scientific society recommends performing any kind of active treatment on the mother that is aimed at protecting the fetus or on the newborn except for offering compassionate care. A general agreement is also evident for week 25 to 25: antenatal steroids are recommended, prenatal transport and cesarean section are also indicated to protect the fetus, and resuscitation is offered to all infants without fatal anomalies. More caution is shown in Switzerland, where resuscitation is initiated on an individual basis, and also in the Netherlands, where cesarean section is rarely performed on fetal indication and the option for active treatment is subject to the consideration of the infant's clinical conditions. On the other hand, in Australasia almost all infants of 24 weeks to 24 weeks are candidates for intensive care. From the reviewed guidelines, it seems clear that 23 to 24 weeks are a sort of "gray zone," where recommendations suggest resuscitation on an "individual basis" and "according to the parents' wishes." In some countries, this gray zone extends through 25 to 25 weeks. In all of the statements, the gestational age is considered the best estimate of the infant's maturation and, consequently, his or her possibility of survival, although many other fetal/neonatal characteristics could play a role in the prognosis. In the case of uncertain gestational age, the guidelines recommend a careful assessment of the infant's condition at birth. In doubtful cases, resuscitation is appropriate until a further assessment of the infant's clinical course clarifies the situation.19,23,24,28,29 Although not influencing the indications for care in terms of weeks of gestation,30 the modern concept of "provisional intensive care"19,28,29 remains a possibility, provided the parents understand the implications of aggressive treatment, and physicians are willing to withdraw ineffective or futile treatment if necessary. The concept of compassionate, comfort, or palliative care is strongly emphasized in the majority of the recommendations. All of the official guidelines in our research on perinatal care surrounding the threat of extremely preterm birth come from industrialized countries, because we could not find any guidelines in developing countries. This is not surprising considering the very high cost of intensive and long-term care for high-risk neonates and the ethical reasons that could lead to different treatment choices in different countries. Another important issue regards how much the availability of such guidelines would affect the survival rate. Unfortunately, this availability may not automatically change the attitudes and behavior of physicians. Research is needed in these fields. From our study it is also evident that, despite being extremely useful, guidelines on this issue are intended as a general framework for helping health practitioners and parents in decision-making in the dramatic event of a threatened extremely preterm birth. Nevertheless, because of the uniqueness of every pregnancy and neonate, to protect mothers and infants from futile treatment, as well as incorrect withholding of life-sustaining treatment, the specific circumstances of every individual situation must always be kept in mind.


   ACKNOWLEDGMENTS
 
We are greatly indebted to our colleagues who have provided information for our work: in Argentina, Nora Balanian, Gustavo Goldsmit, and Celia Lomuto; in Belgium, Dominique Haumont; in Denmark, Klaus Børch, Jesper Fenger-Gron, and Gorm Greisen; in Finland, Sture Andersson, Jukka Rajantie, and Outi Tammela; in France, Guy Putet; in Germany, Gabriele Olbrisch and Christian F. Poets; in Greece, Andreas Constantopoulos; in Hungary, Gyorgy Fekete; in Italy, Carola Hernst; in Norway, Thomas Moller and Ola Saugstad; in Singapore, Lai-Yun Ho; in Switzerland, Thomas M. Berger; in the Netherlands, Arend Bos; and in the United Kingdom, Philip Steer. We also give special thanks to Dr Eduard Verhagen for suggestions for the preparation of the article and to Susan Cadby for her revision of the English-language aspects of the article.


   FOOTNOTES
 
Accepted Jun 19, 2007.

Address correspondence to Maria Serenella Pignotti, MD, Neonatal Medicine, A. Meyer Children's Hospital, University of Florence, via Luca Giordano 13, 50132 Firenze, Italy. E-mail: m.pignotti{at}meyer.it

The authors have indicated they have no financial relationships relevant to this article to disclose.


   REFERENCES
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PEDIATRICS (ISSN 1098-4275). ©2008 by the American Academy of Pediatrics

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