Trial reportThe New England journal of medicine2021
Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia.
Trial report in The New England journal of medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 70 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) Versus Expectant Management During Pregnancy in Fetuses With Left Sided and Isolated Congenital Diaphragmatic Hernia and Moderate Pulmonary Hypoplasia.
A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia
Who cites it
70 citing papers in PubMed, 1 synthesis or guideline pooled it, 259 citations in OpenAlex.
- Comparison of conventional mechanical ventilation and high-frequency oscillatory ventilation in congenital diaphragmatic hernias: a systematic review and meta-analysis.Scientific reports · 2023Pooled it
- Special considerations in randomized trials investigating neonatal surgical treatments.Seminars in perinatology · 2022Trial
- Randomized Trial of Fetal Surgery for Severe Left Diaphragmatic Hernia.The New England journal of medicine · 2021Trial
- Bayesian probabilistic statements for communicating clinical trial results.BMC medicine · 2026Article
- Effect of right- vs left-sided congenital diaphragmatic hernia and duration of tracheal occlusion on longitudinal lung-size changes.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2026Observational
- Impact of Fetoscopic Surgery on the Myometrium: Experimental Study in an Ovine Model of Myelomeningocele.Prenatal diagnosis · 2026Article
- A hemodynamic-driven approach to chronic pulmonary hypertension in congenital diaphragmatic hernia.Journal of perinatology : official journal of the California Perinatal Association · 2026Review
- Pulmonary T2* quantification of fetal lung status in congenital diaphragmatic hernia: future alternative to ultrasound?Pediatric research · 2026Article
- The factors influencing parents and clinicians in medical decision making for fetuses with congenital diaphragmatic hernia at a tertiary referral centre in Beijing: a five-year retrospective study.BMC pregnancy and childbirth · 2026Article
- Patient and public involvement (PPI) reporting in maternal and neonatal clinical trials: an exploratory review.Trials · 2026Review
- A Framework for Prenatal Counselling Recommendations in Congenital Diaphragmatic Hernia: A RAND-Modified Delphi Study.Prenatal diagnosis · 2026Article
- Guidelines for the Medical Management of Congenital Diaphragmatic Hernia: Implications for Resource-limited Settings.Indian pediatrics · 2026Review
- Golden hour management of infants with congenital diaphragmatic hernia: 15 year experience at a high-volume center.Journal of perinatology : official journal of the California Perinatal Association · 2025Article
- Infants With a Congenital Diaphragmatic Hernia Had Favourable Pulmonary Hypertension Outcomes at 1 Year of Age.Acta paediatrica (Oslo, Norway : 1992) · 2025Article
- Review
- Fetal Tracheal Occlusion Correlates with Normalized YAP Expression and Alveolar Epithelial Differentiation in Congenital Diaphragmatic Hernia.American journal of respiratory cell and molecular biology · 2025Article
- Fetal Endoscopic Tracheal Occlusion (FETO) for Left and Right Congenital Diaphragmatic Hernia in Canada.Prenatal diagnosis · 2025Article
- Observed/Expected Lung-To-Head Ratio and Total Lung Volumes That Identify Fetuses With Severe Congenital Diaphragmatic Hernia in a North American Fetal Center.Prenatal diagnosis · 2025Article
- Key Amniotic Fluid miRNAs as Promising Target Molecules for the Antenatal Prevention of Pulmonary Hypoplasia Associated with Congenital Diaphragmatic Hernia.International journal of molecular sciences · 2025Article
- Impact of fetal treatments for congenital diaphragmatic hernia on lung development.Anatomical record (Hoboken, N.J. : 2007) · 2025Review
10 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
15 authors at 11 institutions in 9 countries.
Funding
Abstract
backgroundFetoscopic endoluminal tracheal occlusion (FETO) has been associated with increased postnatal survival among infants with severe pulmonary hypoplasia due to isolated congenital diaphragmatic hernia on the left side, but data are lacking to inform its effects in infants with moderate disease.
methodsIn this open-label trial conducted at many centers with experience in FETO and other types of prenatal surgery, we randomly assigned, in a 1:1 ratio, women carrying singleton fetuses with a moderate isolated congenital diaphragmatic hernia on the left side to FETO at 30 to 32 weeks of gestation or expectant care. Both treatments were followed by standardized postnatal care. The primary outcomes were infant survival to discharge from a neonatal intensive care unit (NICU) and survival without oxygen supplementation at 6 months of age.
resultsIn an intention-to-treat analysis involving 196 women, 62 of 98 infants in the FETO group (63%) and 49 of 98 infants in the expectant care group (50%) survived to discharge (relative risk , 1.27; 95% confidence interval [CI], 0.99 to 1.63; two-sided P = 0.06). At 6 months of age, 53 of 98 infants (54%) in the FETO group and 43 of 98 infants (44%) in the expectant care group were alive without oxygen supplementation (relative risk, 1.23; 95% CI, 0.93 to 1.65). The incidence of preterm, prelabor rupture of membranes was higher among women in the FETO group than among those in the expectant care group (44% vs. 12%; relative risk, 3.79; 95% CI, 2.13 to 6.91), as was the incidence of preterm birth (64% vs. 22%, respectively; relative risk, 2.86; 95% CI, 1.94 to 4.34), but FETO was not associated with any other serious maternal complications. There were two spontaneous fetal deaths (one in each group) without obvious cause and one neonatal death that was associated with balloon removal.
conclusionsThis trial involving fetuses with moderate congenital diaphragmatic hernia on the left side did not show a significant benefit of FETO performed at 30 to 32 weeks of gestation over expectant care with respect to survival to discharge or the need for oxygen supplementation at 6 months. FETO increased the risks of preterm, prelabor rupture of membranes and preterm birth. (Funded by the European Commission and others; TOTAL ClinicalTrials.gov number, NCT00763737.).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.