Article

A randomized trial of fetal endoscopic tracheal occlusion for severe fetal congenital diaphragmatic hernia.

Fetal Treatment Center, University of California, San Francisco, San Francisco, CA 94143-0570, USA.
New England Journal of Medicine (impact factor: 53.3). 11/2003; 349(20):1916-24. DOI:10.1056/NEJMoa035005
Source: PubMed

ABSTRACT Experimental and clinical data suggest that fetal endoscopic tracheal occlusion to induce lung growth may improve the outcome of severe congenital diaphragmatic hernia. We performed a randomized, controlled trial comparing fetal tracheal occlusion with standard postnatal care.
Women carrying fetuses that were between 22 and 27 weeks of gestation and that had severe, left-sided congenital diaphragmatic hernia (liver herniation and a lung-to-head ratio below 1.4), with no other detectable anomalies, were randomly assigned to fetal endoscopic tracheal occlusion or standard care. The primary outcome was survival at the age of 90 days; the secondary outcomes were measures of maternal and neonatal morbidity.
Of 28 women who met the entry criteria, 24 agreed to randomization. Enrollment was stopped after 24 patients had been enrolled because of the unexpectedly high survival rate with standard care and the conclusion of the data safety monitoring board that further recruitment would not result in significant differences between the groups. Eight of 11 fetuses (73 percent) in the tracheal-occlusion group and 10 of 13 (77 percent) in the group that received standard care survived to 90 days of age (P=1.00). The severity of the congenital diaphragmatic hernia at randomization, as measured by the lung-to-head ratio, was inversely related to survival in both groups. Premature rupture of the membranes and preterm delivery were more common in the group receiving the intervention than in the group receiving standard care (mean [+/-SD] gestational age at delivery, 30.8+/-2.0 weeks vs. 37.0+/-1.5 weeks; P<0.001). The rates of neonatal morbidity did not differ between the groups.
Tracheal occlusion did not improve survival or morbidity rates in this cohort of fetuses with congenital diaphragmatic hernia.

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Keywords

11 fetuses
 
24 patients
 
[+/-SD] gestational age
 
congenital diaphragmatic hernia
 
data safety monitoring board
 
detectable anomalies
 
entry criteria
 
fetal endoscopic tracheal occlusion
 
fetal tracheal occlusion
 
induce lung growth
 
left-sided congenital diaphragmatic hernia
 
neonatal morbidity
 
Premature rupture
 
preterm delivery
 
primary outcome
 
received standard care
 
secondary outcomes
 
severe congenital diaphragmatic hernia
 
standard postnatal care
 
tracheal-occlusion group