Evidence map›Paper›PMID 34106555›Full record

Trial reportThe New England journal of medicine2021

Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia.

Jan A Deprest, Alexandra Benachi, Eduard Gratacos, Kypros H Nicolaides, Christoph Berg, Nicola Persico, Michael Belfort, Glenn J Gardener, Yves Ville, Anthony Johnson and 5 more

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 1 pooled it
44.5field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT00763737 nacompletednot on this map

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.

TypeinterventionalSponsorUniversity Hospital, GasthuisbergRan2010 to 2020Enrolled196ConditionsCongenital Diaphragmatic Hernia, Fetal Surgery, Pulmonary HypoplasiaArmsFetoscopic Endoluminal Tracheal Occlusion
NCT06281717 nawithdrawnnot on this mapstarted 2024, after this paper: background citation

A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia

TypeinterventionalSponsorEyal KrispinRan2024 to 2031Enrolled0ConditionsCongenital Diaphragmatic HerniaArmsFetal Endotracheal Occlusion (FETO)
3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 1 synthesis or guideline pooled it, 259 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. 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 · 2026
    Observational
  6. Article
  7. A hemodynamic-driven approach to chronic pulmonary hypertension in congenital diaphragmatic hernia.Journal of perinatology : official journal of the California Perinatal Association · 2026
    Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. 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 · 2025
    Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review

10 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 9 countries.

Jan A DeprestFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).ORCID 0000-0002-4920-945X
Alexandra BenachiFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).
Eduard GratacosFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).
Kypros H NicolaidesFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).
Christoph BergFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).
Nicola PersicoFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).
Michael BelfortFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).
Glenn J GardenerFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).
Yves VilleFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).
Anthony JohnsonFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).
Francesco MoriniFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).
Mirosław WielgośFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).
Ben Van CalsterFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).
Philip L J DeKoninckFrom the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine-Béclère, Université Paris-Saclay, Clamart (A.B.), and Necker-Enfants Malades Hospital, Paris (Y.V.) - both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women's Health, University College London Hospital (J.A.D.) and King's College Hospital(K.H.N.) - both in London; the University Hospital Bonn, Bonn, Germany (C.B.); Hospital Maggiore Policlinico, Milan (N.P.), and Bambino Gesù Children's Hospital, Rome (F.M.) - both in Italy; Baylor College of Medicine and Texas Children's Hospital (M.B.) and Children's Memorial Hermann Hospital (A.J.) - all in Houston; Mater Mothers' Hospital, Brisbane, QLD, Australia (G.J.G.); the Medical University of Warsaw, Warsaw, Poland (M.W.); and Erasmus MC-University Medical Center Rotterdam, Rotterdam, the Netherlands (P.L.J.D.).
TOTAL Trial for Moderate Hypoplasia Investigators
University College London · GBBambino Gesù Children's Hospital · ITBaylor College of Medicine · USHospital Sant Joan de Déu Barcelona · ESKing's College Hospital · GBMater Mothers' Hospital · AUMedical University of Warsaw · PLMemorial Hermann · USOspedale Maggiore · ITUniversité Paris-Saclay · FRUniversity Hospital Bonn · DE

Funding

Sixth Framework Programme "EuroSTEC" FP6-LIFESCIHEALTH CT 2006-37409Wellcome Trust 101957
6 · The paper itself

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.).

Indexed as

Balloon OcclusionAdultFemaleFetal TherapiesFetoscopyGestational AgeHernias, Diaphragmatic, CongenitalHumansIntention to Treat AnalysisObstetric Labor, PrematurePatient AcuityPregnancyPremature BirthPremature Rupture of Fetal MembranesTracheaWatchful Waiting

Identifiers

PMID34106555
PMCPMC7613454
OpenAlexW3171783549

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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.