A Randomized Trial of Fetal Endoscopic Tracheal Occlusion for Severe Fetal Congenital Diaphragmatic Hernia

Michael R. Harrison, Roberta L. Keller, Samuel B. Hawgood, Joseph A. Kitterman, Per L. Sandberg, Diana L Farmer, Hanmin Lee, Roy A. Filly, Jody A. Farrell, Craig T. Albanese

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: 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-ned a randomized, controlled trial comparing fetal tracheal occlusion with standard postnatal care. METHODS: 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. RESULTS: 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. CONCLUSIONS: Tracheal occlusion did not improve survival or morbidity rates in this cohort of fetuses with congenital diaphragmatic hernia.

Original languageEnglish (US)
Pages (from-to)1916-1924
Number of pages9
JournalNew England Journal of Medicine
Volume349
Issue number20
DOIs
StatePublished - Nov 13 2003

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Fetus
Random Allocation
Morbidity
Lung
Survival
Clinical Trials Data Monitoring Committees
Head
Postnatal Care
Standard of Care
Gestational Age
Survival Rate
Randomized Controlled Trials
Mothers
Outcome Assessment (Health Care)
Pregnancy
Congenital Diaphragmatic Hernias
Liver
Growth
Preterm Premature Rupture of the Membranes

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Harrison, M. R., Keller, R. L., Hawgood, S. B., Kitterman, J. A., Sandberg, P. L., Farmer, D. L., ... Albanese, C. T. (2003). A Randomized Trial of Fetal Endoscopic Tracheal Occlusion for Severe Fetal Congenital Diaphragmatic Hernia. New England Journal of Medicine, 349(20), 1916-1924. https://doi.org/10.1056/NEJMoa035005

A Randomized Trial of Fetal Endoscopic Tracheal Occlusion for Severe Fetal Congenital Diaphragmatic Hernia. / Harrison, Michael R.; Keller, Roberta L.; Hawgood, Samuel B.; Kitterman, Joseph A.; Sandberg, Per L.; Farmer, Diana L; Lee, Hanmin; Filly, Roy A.; Farrell, Jody A.; Albanese, Craig T.

In: New England Journal of Medicine, Vol. 349, No. 20, 13.11.2003, p. 1916-1924.

Research output: Contribution to journalArticle

Harrison, MR, Keller, RL, Hawgood, SB, Kitterman, JA, Sandberg, PL, Farmer, DL, Lee, H, Filly, RA, Farrell, JA & Albanese, CT 2003, 'A Randomized Trial of Fetal Endoscopic Tracheal Occlusion for Severe Fetal Congenital Diaphragmatic Hernia', New England Journal of Medicine, vol. 349, no. 20, pp. 1916-1924. https://doi.org/10.1056/NEJMoa035005
Harrison, Michael R. ; Keller, Roberta L. ; Hawgood, Samuel B. ; Kitterman, Joseph A. ; Sandberg, Per L. ; Farmer, Diana L ; Lee, Hanmin ; Filly, Roy A. ; Farrell, Jody A. ; Albanese, Craig T. / A Randomized Trial of Fetal Endoscopic Tracheal Occlusion for Severe Fetal Congenital Diaphragmatic Hernia. In: New England Journal of Medicine. 2003 ; Vol. 349, No. 20. pp. 1916-1924.
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abstract = "BACKGROUND: 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-ned a randomized, controlled trial comparing fetal tracheal occlusion with standard postnatal care. METHODS: 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. RESULTS: 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. CONCLUSIONS: Tracheal occlusion did not improve survival or morbidity rates in this cohort of fetuses with congenital diaphragmatic hernia.",
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AU - Harrison, Michael R.

AU - Keller, Roberta L.

AU - Hawgood, Samuel B.

AU - Kitterman, Joseph A.

AU - Sandberg, Per L.

AU - Farmer, Diana L

AU - Lee, Hanmin

AU - Filly, Roy A.

AU - Farrell, Jody A.

AU - Albanese, Craig T.

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N2 - BACKGROUND: 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-ned a randomized, controlled trial comparing fetal tracheal occlusion with standard postnatal care. METHODS: 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. RESULTS: 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. CONCLUSIONS: Tracheal occlusion did not improve survival or morbidity rates in this cohort of fetuses with congenital diaphragmatic hernia.

AB - BACKGROUND: 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-ned a randomized, controlled trial comparing fetal tracheal occlusion with standard postnatal care. METHODS: 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. RESULTS: 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. CONCLUSIONS: Tracheal occlusion did not improve survival or morbidity rates in this cohort of fetuses with congenital diaphragmatic hernia.

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