Evidence map›Paper›PMID 34453917›Full record

Trial reportThe Journal of pediatrics2021

Sustained Inflation Versus Intermittent Positive Pressure Ventilation for Preterm Infants at Birth: Respiratory Function and Vital Sign Measurements.

Elizabeth E Foglia, Haresh Kirpalani, Sarah J Ratcliffe, Peter G Davis, Marta Thio, Helmut Hummler, Gianluca Lista, Francesco Cavigioli, Georg M Schmölzer, Martin Keszler and 1 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of 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 NCT02139800 (Sustained Aeration of Infant Lungs Trial), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 35% 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.

NCT02139800 nacompletednot on this map

Sustained Aeration of Infant Lungs Trial

TypeinterventionalSponsorUniversity of PennsylvaniaRan2014 to 2020Enrolled460ConditionsPreterm Birth, Extreme PrematurityArmsSustained Inflation, Standard of Care
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. 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

11 authors at 7 institutions in 5 countries.

Elizabeth E FogliaDivision of Neonatology, Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. Electronic address: foglia@chop.edu.
Haresh KirpalaniDivision of Neonatology, Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Sarah J RatcliffeDivision of Biostatistics, Department of Public Health Sciences, University of Virginia, Charlottesville, VA.
Peter G DavisNewborn Research Center, The Royal Women's Hospital and The University of Melbourne, Victoria, Australia.
Marta ThioNewborn Research Center, The Royal Women's Hospital and The University of Melbourne, Victoria, Australia.
Helmut HummlerDepartment of Pediatrics, Sidra Medicine, Doha, Qatar.
Gianluca ListaDepartment of Pediatrics, NICU, Ospedale dei Bambini V.Buzzi ASST-FBF-Sacco, Milan, Italy.
Francesco CavigioliDepartment of Pediatrics, NICU, Ospedale dei Bambini V.Buzzi ASST-FBF-Sacco, Milan, Italy.
Georg M SchmölzerDepartment of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.
Martin KeszlerDepartment of Pediatrics, Alpert Medical School of Brown University, Women and Infants Hospital of Rhode Island, Providence, RI.
Arjan B Te PasDepartment of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.
Ospedale dei Bambini Vittore Buzzi · ITRoyal Women's Hospital · AUUniversity of Pennsylvania · USBrown University · USLeiden University Medical Center · NLUniversity of Alberta · CAUniversity of Virginia · US

Funding

The SAIL trial [Sustained Aeration of Infant Lungs]U01HD072906 · NICHD · CHILDREN'S HOSP OF PHILADELPHIA · PI KESZLER, MARTIN, KIRPALANI, HARESH · 2013 to 2017
$5.5M
Optimizing Respiratory Function in Delivery Room Resuscitation: The INFLATE Study (INFant Lung Aeration during Transition Events)K23HD084727 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI FOGLIA, ELIZABETH · 2016 to 2020
$809k
Respiratory function monitoring during resuscitation of extremely preterm infants: An ancillary study to the SAIL trialR03HD086655 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI FOGLIA, ELIZABETH, KIRPALANI, HARESH · 2016 to 2017
$171k
NICHD NIH HHS K23 HD084727NICHD NIH HHS R03 HD086655NICHD NIH HHS U01 HD072906
6 · The paper itself

Abstract

objectiveTo characterize respiratory function monitor (RFM) measurements of sustained inflations and intermittent positive pressure ventilation (IPPV) delivered noninvasively to infants in the Sustained Aeration of Infant Lungs (SAIL) trial and to compare vital sign measurements between treatment arms. STUDY

designWe analyzed RFM data from SAIL participants at 5 trial sites. We assessed tidal volumes, rates of airway obstruction, and mask leak among infants allocated to sustained inflations and IPPV, and we compared pulse rate and oxygen saturation measurements between treatment groups.

resultsAmong 70 SAIL participants (36 sustained inflations, 34 IPPV) with RFM measurements, 40 (57%) were spontaneously breathing prior to the randomized intervention. The median expiratory tidal volume of sustained inflations administered was 5.3 mL/kg (IQR 1.1-9.2). Significant mask leak occurred in 15% and airway obstruction occurred during 17% of sustained inflations. Among 34 control infants, the median expiratory tidal volume of IPPV inflations was 4.3 mL/kg (IQR 1.3-6.6). Mask leak was present in 3%, and airway obstruction was present in 17% of IPPV inflations. There were no significant differences in pulse rate or oxygen saturation measurements between groups at any point during resuscitation.

conclusionExpiratory tidal volumes of sustained inflations and IPPV inflations administered in the SAIL trial were highly variable in both treatment arms. Vital sign values were similar between groups throughout resuscitation. Sustained inflation as operationalized in the SAIL trial was not superior to IPPV to promote lung aeration after birth in this study subgroup.

trial registrationClinicaltrials.gov: NCT02139800.

Indexed as

Continuous Positive Airway PressureFemaleGestational AgeHumansInfant, Extremely PrematureInfant, NewbornInfant, PrematureIntermittent Positive-Pressure VentilationMaleRespiratory Function TestsResuscitationpretermresuscitationsustained inflation

Identifiers

PMID34453917
PMCPMC8604776
OpenAlexW3195016735

What OpenQuestion holds

Textmetadata
LicenceTDM
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.