A Randomized Trial of Fetal Endoscopic Tracheal Occlusion for Severe Fetal Congenital Diaphragmatic Hernia
Michael R. Harrison, M.D., Roberta L. Keller, M.D., Samuel B. Hawgood, M.D., Joseph A. Kitterman, M.D., Per L. Sandberg, M.D., Diana L. Farmer, M.D., Hanmin Lee, M.D., Roy A. Filly, M.D., Jody A. Farrell, M.S.N., P.N.P., and Craig T. Albanese, M.D.
Background Experimental and clinical data suggest that fetalendoscopic tracheal occlusion to induce lung growth may improvethe outcome of severe congenital diaphragmatic hernia. We performeda randomized, controlled trial comparing fetal tracheal occlusionwith standard postnatal care.
Methods Women carrying fetuses that were between 22 and 27 weeksof gestation and that had severe, left-sided congenital diaphragmatichernia (liver herniation and a lung-to-head ratio below 1.4),with no other detectable anomalies, were randomly assigned tofetal endoscopic tracheal occlusion or standard care. The primaryoutcome was survival at the age of 90 days; the secondary outcomeswere measures of maternal and neonatal morbidity.
Results Of 28 women who met the entry criteria, 24 agreed torandomization. Enrollment was stopped after 24 patients hadbeen enrolled because of the unexpectedly high survival ratewith standard care and the conclusion of the data safety monitoringboard that further recruitment would not result in significantdifferences between the groups. Eight of 11 fetuses (73 percent)in the tracheal-occlusion group and 10 of 13 (77 percent) inthe group that received standard care survived to 90 days ofage (P=1.00). The severity of the congenital diaphragmatic herniaat randomization, as measured by the lung-to-head ratio, wasinversely related to survival in both groups. Premature ruptureof the membranes and preterm delivery were more common in thegroup receiving the intervention than in the group receivingstandard 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.
Conclusions Tracheal occlusion did not improve survival or morbidityrates in this cohort of fetuses with congenital diaphragmatichernia.
Source Information
From the Fetal Treatment Center (M.R.H., S.B.H., J.A.K., P.L.S., D.L.F., H.L., R.A.F., J.A.F., C.T.A.), the Departments of Surgery (M.R.H., D.L.F., H.L., J.A.F., C.T.A.), Pediatrics (M.R.H., R.L.K., S.B.H., J.A.K., D.L.F., H.L., C.T.A.), Obstetrics, Gynecology and Reproductive Sciences (M.R.H., P.L.S., D.L.F., H.L., R.A.F., C.T.A.), and Radiology (R.A.F.), and the Cardiovascular Research Institute (R.L.K., J.A.K.), University of California, San Francisco, San Francisco.
Address reprint requests to Dr. Harrison at the University of California, San Francisco, Fetal Treatment Center, 513 Parnassus Ave., HSW-1601, San Francisco, CA 94143-0570, or at fetus{at}surgery.ucsf.edu.
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