CORRECTION OF CONGENITAL DIAPHRAGMATIC-HERNIA IN-UTERO .7. A PROSPECTIVE TRIAL

Background: Congenital diaphragmatic hernia (CDH) remains an unsolved problem. Despite optimal postnatal care, up to 60% of CDH babies die, Experimental evidence and clinical experience have shown that in utero repair of CDH is feasible and can reverse pulmonary hypoplasia, but o nly in fetuses without liver herniation. For this subgroup, the safety and efficacy of repair before birth has not been compared with standa rd care after birth. Methods: Four fetuses in whom CDH without liver h erniation was diagnosed underwent open fetal surgery for repair of the CDH. Seven comparison fetuses were treated conventionally. Neonatal m ortality was the principle outcome variable. Secondary outcome variabl es included death of all causes until 2 years of age, number of days o f ventilatory support, length of hospital stay, requirement for extrac orporeal membrane oxygenation (ECMO), and total hospital charges. Resu lts: There was no difference in survival between the fetal surgery gro up and the postnatally treated comparison group (75% v 86%). Fetal sur gery patients were born mole prematurely than the comparison group (32 weeks v 38 weeks' gestation). Length of ventilatory support and requi rement for ECMO were equivalent in the fetal surgery group and the pos tnatally treated comparison group. Length of hospital stay and hospita l charges did not differ between the groups.Conclusions: Open fetal su rgery is physiologically sound and technically feasible, but does not improve survival over standard postnatal treatment in the subgroup of CDH fetuses without liver herniation, primarily because overall surviv al in this subgroup is favorable with or without prenatal intervention . These data suggest that fetuses who have prenatally diagnosed CDH an d without evidence of liver herniation should be treated postnatally. Copyright (C) 1997 by W.B. Saunders Company.