Evidence map›Paper›PMID 34125148›Full record

Trial reportJAMA pediatrics2021

Comparison of Respiratory Support After Delivery in Infants Born Before 28 Weeks' Gestational Age: The CORSAD Randomized Clinical Trial.

Snorri Donaldsson, Thomas Drevhammar, Yinghua Li, Marco Bartocci, Siren Irene Rettedal, Fredrik Lundberg, Per Odelberg-Johnson, Tomasz Szczapa, Thordur Thordarson, Ingrida Pilypiene and 5 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in JAMA pediatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02563717 (A Randomised Controlled Trial of Delivery Room Intubation Rates Comparing a New System and T-piece Resuscitation System for Initial Stabilisation of Infants Born <28 Weeks), which is not on this map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
3.8field-weighted citation impact, top 6% 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.

NCT02563717 nacompletednot on this map

A Randomised Controlled Trial of Delivery Room Intubation Rates Comparing a New System and T-piece Resuscitation System for Initial Stabilisation of Infants Born <28 Weeks

TypeinterventionalSponsorBaldvin JonssonRan2016 to 2020Enrolled250ConditionsRespiration, Insufficient or Poor, Newborn, Infant, Premature, DiseasesArmsT-piece used for respiratory support (several manufacturers), New system used for respiratory support
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Nasal interfaces for neonatal resuscitation.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Guideline
  4. Article
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  11. Observational
  12. Review
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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

15 authors at 10 institutions in 6 countries.

Snorri DonaldssonDepartment of Neonatology, Karolinska University Hospital, Stockholm, Sweden.
Thomas DrevhammarDepartment of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.
Yinghua LiDepartment of Neonatology, Karolinska University Hospital, Stockholm, Sweden.
Marco BartocciDepartment of Neonatology, Karolinska University Hospital, Stockholm, Sweden.
Siren Irene RettedalDepartment of Neonatology, Stavanger University Hospital, Stavanger, Norway.
Fredrik LundbergDepartment of Neonatology, Linköping University Hospital, Linköping, Sweden.
Per Odelberg-JohnsonDepartment of Neonatology, Linköping University Hospital, Linköping, Sweden.
Tomasz SzczapaDepartment of Neonatology, Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit, Poznan University of Medical Sciences, Poznan, Poland.
Thordur ThordarsonDepartment of Neonatology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Ingrida PilypieneDepartment of Neonatology, Vilnius University Hospital, Vilnius, Lithuania.
Thordur ThorkelssonDepartment of Neonatology, The National University Hospital of Iceland, Reykjavík, Iceland.
Lars SoderstromUnit of Research, Education and Development, Östersund Hospital, Östersund, Sweden.
Vladimiras ChijenasDepartment of Neonatology, Vilnius Maternity Hospital, Vilnius, Lithuania.
Baldvin JonssonDepartment of Neonatology, Karolinska University Hospital, Stockholm, Sweden.
CORSAD Trial Investigators
Clinical Trial Investigators · USKarolinska University Hospital · SELinköping University Hospital · SEKarolinska Institutet · SENational University Hospital of Iceland · ISÖstersunds Hospital · SEPoznan University of Medical Sciences · PLSahlgrenska University Hospital · SEStavanger University Hospital · NOVilnius University · LT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Establishing stable breathing is a key event for preterm infants after birth. Delivery of pressure-stable continuous positive airway pressure and avoiding face mask use could be of importance in the delivery room. Objective: To determine whether using a new respiratory support system with low imposed work of breathing and short binasal prongs decreases delivery room intubations or death compared with a standard T-piece system with a face mask. Design, Setting, and Participants: In this unblinded randomized clinical trial, mothers threatening preterm delivery before week 28 of gestation were screened. A total of 365 mothers were enrolled, and 250 infants were randomized before birth and 246 liveborn infants were treated. The trial was conducted in 7 neonatal intensive care units in 5 European countries from March 2016 to May 2020. The follow-up period was 72 hours after intervention. Interventions: Infants were randomized to either the new respiratory support system with short binasal prongs (n = 124 infants) or the standard T-piece system with face mask (n = 122 infants). The intervention was providing continuous positive airway pressure for 10 to 30 minutes and positive pressure ventilation, if needed, with the randomized system. Main Outcomes and Measures: The primary outcome was delivery room intubation or death within 30 minutes of birth. Secondary outcomes included respiratory and safety variables. Results: Of 246 liveborn infants treated, the mean (SD) gestational age was 25.9 (1.3) weeks, and 127 (51.6%) were female. A total of 41 infants (33.1%) receiving the new respiratory support system were intubated or died in the delivery room compared with 55 infants (45.1%) receiving standard care. The adjusted odds ratio was statistically significant after adjusting for stratification variables (adjusted odds ratio, 0.53; 95% CI, 0.30-0.94; P = .03). No significant differences were seen in secondary outcomes or safety variables. Conclusions and Relevance: In this study, using the new respiratory support system reduced delivery room intubation in extremely preterm infants. Stabilizing preterm infants with a system that has low imposed work of breathing and binasal prongs as interface is safe and feasible. Trial Registration: ClinicalTrials.gov Identifier: NCT02563717.

Indexed as

Gestational AgeDelivery, ObstetricFemaleHumansInfant, NewbornIntensive Care Units, NeonatalMaleOdds RatioOutcome Assessment, Health CareRespiratory TherapySweden

Identifiers

PMID34125148
PMCPMC8424478
OpenAlexW3168408070

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.