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Re: Management of babies born extremely preterm at less than 26 weeks of gestation.

Dear Editor, I have read with great interest the article by Wilkinson et al (1) discussing one of the most challenging aspects of perinatal medicine. These authors most appropriately point out that treatment of ELBW newborns needs to be customized and that any intervention should be performed in the patient’s best interest. The authors also emphasise the important role parents have in deciding whether to start and/or continue resuscitation. Nowadays the approach of neonatologists to the medical care of extremely premature newborn differs from country to country, as it is influenced by different medical, social ethical and legal considerations. For instance, in Italy parental rights are meant as a role rather than as a subjective privilege, since parental authority is basically centred on the sole interest of the child. Moreover, any decision made by the parents should be based on the actual understanding of correct information. When dealing with an extremely preterm delivery, a physician is faced with the need to make rapid decisions, but he or she is often unable to foresee the prognosis and therefore to provide the parents with all the necessary information that would allow them to participate in the decision process with full awareness. Hence, in the case of urgent interventions, the physician cannot share the responsibility of the choices made to try to achieve the best perspectives of life and health for the newborn. In Italy, even in case of extreme prematurity, every newborn attains the legal status of person, and as such is fully entitled by the Constitution (Art. 3) to get all the medical care he or she requires. This, therefore, makes unacceptable the fact that some premature children get all the necessary health care because their physician and parents have so decided that they should, whereas others are abandoned because their parents and physicians have taken the opposite decision. Equally arbitrary is perhaps the a priori decision by a physician and/or parent to provide or not provide health care to a newborn on the mere basis of statistical criteria that estimate survival only by gestational age. It should be borne in mind that gestational age is often unknown and that it cannot necessarily be defined in ELBW infants on the basis of their clinical signs at birth. Perhaps the severity of the disease rather than gestational age is the element that should be most accounted for in providing medical care to an ELBW child. Experience tells us that a child born at 26 weeks’ gestation may be in worse conditions than one born at 24 weeks. Of course, in case of extreme prematurity, if the neonatologist realizes that any therapeutic effort is useless, intensive therapies that could translate into pursuit of futile treatment should of course be curtailed.

Mario De Curtis Department of Gynaecological Sciences, Perinatology and Puericulture La Sapienza University, Rome, Italy

Reference

Send letter to journal:
Re: The Management of Babies born Extremely Preterm at less than 26 weeks of gestation

Sir, the paper of Wilkinson and colleagues describes an approach to resuscitation of extremely preterm newborn we believe excessively schematic, based only on gestational age and parental expectations. In the same document intensive therapies are suggested only for newborns of 23-24 weeks who show capability of survival, therefore the burden of proof for obtaining intensive care is put on children who have to demonstrate favourable clinical criteria. Although an increased risk of major negative neurological outcomes is well known in infants born at very small gestational age, selective resuscitation leads to smaller percentage of infants survived without disabilities.(1) It has been demonstrated that a proactive approach may increase survival rates without any increased risk of major disability.(2) In a relative perspective it is hardly comprehensible why these little patients should be differently treated with respect to older children and adults who have just a quarter of probability of survival after a cardiac arrest, without violating the principle of justice.(3,4) In an absolute perspective the probability of success for resuscitation of 23-24 weeks newborns is well above the threshold of medical futility.(5) Children are not a property, parents have a duty to protect interests of their children and eventual disabilities can never be considered worst than death, unless modern society wants to reintroduce the concept of “lives not worth living”.(6) In the EPICure 2 study survival of very preterm babies remains extremely rare, but authors conclude that “These national population-based data show increased survival at all gestational ages less than 26 weeks but no clear evidence of change of major morbidity; the increased numbers of babies treated for retinopathy of prematurity may be attributable to improved screening and lowered threshold for treatment”.(7) At present, a selective resuscitation has been approved neither by any Italian scientific society, as far as we know, nor by the Italian Superior Council of Health, which is the technical advisory council of the Minister of Health.(8) Similarly, overall perspective of the Florentine document has not been approved by the National Bioethics Committee.(9)

Arosio P. ASL 3 Monza,Bellieni C TIN Siena, Biasini A UO TIN Cesena, Cocchi G UO-Neonatologia AOSP Bologna, Doni D. TIN Monza, Guerrini L UO Neonatologia Pisa , Isimbaldi C UO Pediatria Merate, Locatelli C. Neonatologia Bologna,Paterlini G TIN Monza, Puccetti R.. Promed Galileo IMS - Bioethic Area Pisa, Rinaldi M.R. Neonatologia Catania, Squicciarini E TIN Acquaviva delle Fonti, Villani G TIN Foggia , Villani P Neonatologia e TIN Brescia

References:

1.Lorenz JM, Paneth N, Jetton JR, Ouden L, Tyson JE. Comparison of management strategies for extreme prematurity in New Jersey and the Netherlands: outcomes and resource expenditure. Pediatrics. 2001;108: 1269–1274

2.Hakansson S, Farooqi A, Holmgrem PA, Serenius F, Hogberg U:Proactive Management Promotes Outcome in Extremely Preterm Infants: A population-based Comparison of two Perinatal Management Strategies. Pediatrics Vol. 2004, 114:58-64.

3.Berg MD, Nadkarni VM, Berg RA. Cardiopulmonary resuscitation in children. Curr Opin Crit Care. 2008 Jun;14(3):254-60.

4.Peberdy MA, Ornato JP, Larkin GL, Braithwaite RS, Kashner TM, Carey SM, Meaney PA, Cen L, Nadkarni VM, Praestgaard AH, Berg RA; National Registry of Cardiopulmonary Resuscitation Investigators. Survival from in- hospital cardiac arrest during nights and weekends. JAMA. 2008 Feb 20;299(7):785-92.

5.Schneiderman LJ, Jecker NS, Jonsen AR. Medical futility: its meaning and ethical implications. Ann Intern Med. 1990; 112:949-54

6.Janvier A., The Best – Interest Is Not Applied for Neonatal Resuscitation Decisions Pediatrics 2008; 121; 963-969

7.EPICure 2 Perinatal Group. Survival and early morbidity of extremely preterm babies in England: changes since1995. Arch Dis Child 2008; 93:(Supp 1):A33-34.

8.Ministero della Salute. Comunicato n. 64 4 marzo 2008. http://www.salute.gov.it/imgs/C_17_comunicati_1567_testo.rtf

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Re: Decision making and clinical practice for infants born at less than 26 weeks' gestation

Dear Editor,

Recently Wilkinson et al. proposed a framework for decision making and clinical practice for the care of infants born at the limits of viability. (1) They emphasize the importance of using estimates of outcomes to individualize decision making. Their framework utilizes gestational age as the primary variable for predicting outcomes, which are based on data from the EPICure studies.(2, 3) They acknowledge that other factors may modify outcomes and “should be taken into account when discussing management with parents”. However, these factors are not incorporated into the basic framework of decision making. Because some modifiers may have a profound effect on outcomes, we suggest that they should be incorporated into estimates used for counseling and decision making.

Tyson et al. developed a model for predicting outcomes of infants born between 22 and 25 weeks' gestation that incorporates five factors (gestational age, gender, birth weight, antenatal corticosteroids, and single or multiple birth). (4) Using this model, a hypothetical example illustrates the effect antenatal factors, in addition to gestational age, may have on outcomes. For example, a 23-week, singleton, female infant with a birth weight of 550 grams, whose mother received antenatal corticosteroids has an estimated survival of 33% and survival without profound impairment of 22%. Likewise, for a 23-week, singleton, male infant with a birth weight of 450 grams, whose mother did not receive antenatal corticosteroids these rates are 8% and 4%, respectively. Survival based on the EPIcure study data, using gestational age alone, would be approximately 11%. (1)

A predictive model that incorporates major modifiers of outcomes adds precision to estimates and facilitates decision making. We suggest development of a framework for decision making, with a structure similar to that proposed by Wilkinson et al., but based on a predictive model and not gestational age alone.

References

1. Wilkinson AR, Ahluwalia J, Cole A, Crawford D, Fyle J, Gordon A, et al. Management of babies born extremely preterm at less than 26 weeks of gestation: a framework for clinical practice at the time of birth. Arch Dis Child Fetal Neonatal Ed 2009;94(1):F2-5.

2. Costeloe K, Hennessy E, Gibson AT, Marlow N, Wilkinson AR. The EPICure study: outcomes to discharge from hospital for infants born at the threshold of viability. Pediatrics 2000;106(4):659-71.

3. EPICure PG. Survival and early morbidity of extremely preterm babies in England: changes since 1995. Arch Dis Child Fetal Neonatal Ed 2008;93 (Suppl 1):A33-4.