Evidence map›Paper›PMID 22047542›Full record

Trial reportBMC pediatrics2011

The VICI-trial: high frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international multicentre randomized controlled trial.

Lieke van den Hout, Dick Tibboel, Sanne Vijfhuize, Harma te Beest, Wim Hop, Irwin Reiss, CDH-EURO Consortium

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
5.0field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Association between initial ventilation mode and hospital outcomes for severe congenital diaphragmatic hernia.Journal of perinatology : official journal of the California Perinatal Association · 2024
    Article
  4. Article
  5. Review
  6. Review
  7. Prognosis of conventional vs. high-frequency ventilation for congenital diaphragmatic hernia: a retrospective cohort study.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Article
  8. Article
  9. Review
  10. Congenital Diaphragmatic hernia - a review.Maternal health, neonatology and perinatology · 2017
    Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Lieke van den HoutIntensive Care and Department of Pediatric Surgery, Erasmus MC-Sophia, Dr. Molewaterplein 50, Rotterdam, the Netherlands.
Dick Tibboel
Sanne Vijfhuize
Harma te Beest
Wim Hop
Irwin Reiss
CDH-EURO Consortium
Erasmus MC - Sophia Children’s Hospital · NLErasmus University Rotterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCongenital diaphragmatic hernia (CDH) is a severe congenital anomaly of the diaphragm resulting in pulmonary hypoplasia and pulmonary hypertension. It is associated with a high risk of mortality and pulmonary morbidity. Previous retrospective studies have reported high frequency oscillatory ventilation (HFO) to reduce pulmonary morbidity in infants with CDH, while others indicated HFO to be associated with worse outcome. We therefore aimed to develop a randomized controlled trial to compare initial ventilatory treatment with high-frequency oscillation and conventional ventilation in infants with CDH. METHODS/

designThis trial is designed as a multicentre trial in which 400 infants (200 in each arm) will be included. Primary outcome measures are BPD, described as oxygen dependency by day 28 according to the definition of Jobe and Bancalari, and/or mortality by day 28. All liveborn infants with CDH born at a gestational age of over 34 weeks and no other severe congenital anomalies are eligible for inclusion. Parental informed consent is asked antenatally and the allocated ventilation mode starts within two hours after birth. Laboratory samples of blood, urine and tracheal aspirate are taken at the first day of life, day 3, day 7, day 14 and day 28 to evaluate laboratory markers for ventilator-induced lung injury and pulmonary hypertension. DISCUSSION: To date, randomized clinical trials are lacking in the field of CDH. The VICI-trial, as the first randomized clinical trial in the field of CDH, may provide further insight in ventilation strategies in CDH patient. This may hopefully prevent mortality and morbidity.

trial registrationNetherlands Trial Register (NTR): NTR1310.

Indexed as

Hernias, Diaphragmatic, CongenitalFemaleFollow-Up StudiesGestational AgeHernia, DiaphragmaticHigh-Frequency VentilationHumansInfant MortalityInfant, NewbornMaleProspective StudiesRespiratory Distress Syndrome, NewbornSurvival RateTreatment Outcome

Identifiers

PMID22047542
PMCPMC3226543
OpenAlexW2137052600

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.