Evidence map›Paper›PMID 26500107›Full record

Trial reportThe Journal of pediatrics2016

Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide.

Roberta A Ballard, Roberta L Keller, Dennis M Black, Philip L Ballard, Jeffrey D Merrill, Eric C Eichenwald, William E Truog, Mark C Mammel, Robin H Steinhorn, Elizabeth E Rogers and 16 more

3 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
7.9field-weighted citation impact, top 2% 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.

NCT01022580 phase3completednot on this map

Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia: A Study in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide

TypeinterventionalSponsorRoberta BallardRan2010 to 2016Enrolled511ConditionsBronchopulmonary DysplasiaArmsInfasurf surfactant (ONY, Inc.), Sham (No Treatment)
NCT03576885 phase1 / phase2terminatednot on this mapstarted 2019, after this paper: background citation

Treatment of Delayed Pulmonary Transition in Extremely Preterm Infants & Bronchopulmonary Dysplasia

TypeinterventionalSponsorAdventHealthRan2019 to 2023Enrolled32ConditionsPulmonary Hypertension, Bronchopulmonary DysplasiaArmsinhaled nitric oxide, Placebo
NCT04825197 phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

Effects of Late Surfactant Treatment Delivered After a Recruitment Maneuver on Respiratory Outcomes in Extremely Low Gestational Age Newborns: a Randomized Controlled Trial - LATE-REC-SURF Trial

TypeinterventionalSponsorVENTO GIOVANNIRan2021 to 2025Enrolled20ConditionsBronchopulmonary Dysplasia, Chronic Pulmonary Insufficiency of PrematurityArmsPoractant Alfa Intratracheal Suspension [Curosurf]
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 82 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Randomised trial of azithromycin to eradicateArchives of disease in childhood. Fetal and neonatal edition · 2020
    Trial
  4. Trial
  5. Ancestry and genetic associations with bronchopulmonary dysplasia in preterm infants.American journal of physiology. Lung cellular and molecular physiology · 2018
    Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Review
  19. Comparative efficacy and safety of late surfactant preparations: a retrospective study.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Article
  20. Review
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

26 authors at 16 institutions in 1 country.

Roberta A BallardDepartment of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA. Electronic address: ballardr@peds.ucsf.edu.
Roberta L KellerDepartment of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA.
Dennis M BlackDepartment of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.
Philip L BallardDepartment of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA.
Jeffrey D MerrillDepartment of Pediatrics, UCSF Benioff Children's Hospital Oakland, Oakland, CA.
Eric C EichenwaldDepartment of Pediatrics, The University of Texas Health Science Center Houston, Houston, TX.
William E TruogDepartment of Pediatrics, Children's Mercy Hospital, Kansas City, MO.
Mark C MammelDepartment of Pediatrics, Children's Hospitals and Clinics of Minnesota, St Paul, MN.
Robin H SteinhornDepartment of Pediatrics, UC Davis Children's Hospital, Sacramento, CA.
Elizabeth E RogersDepartment of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA.
Rita M RyanDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
David J DurandDepartment of Pediatrics, UCSF Benioff Children's Hospital Oakland, Oakland, CA.
Jeanette M AsselinDepartment of Pediatrics, UCSF Benioff Children's Hospital Oakland, Oakland, CA.
Catherine M BendelDepartment of Pediatrics, University of Minnesota Amplatz Children's Hospital, Minneapolis, MN.
Ellen M Bendel-StenzelDepartment of Pediatrics, Children's Hospitals and Clinics of Minnesota, Minneapolis, MN.
Sherry E CourtneyDepartment of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR.
Ramasubbareddy DhanireddyDepartment of Pediatrics, The University of Tennessee Health Science Center, Memphis, TN.
Mark L HudakDepartment of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL.
Frances R KochDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
Dennis E MayockDepartment of Pediatrics, University of Washington, Seattle, WA.
Victor J McKayDepartment of Pediatrics, All Children's Hospital, St Petersburg, FL.
T Michael O'SheaDepartment of Pediatrics, Wake Forest School of Medicine and Forsyth Medical Center, Winston-Salem, NC.
Nicolas F PortaDepartment of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL.
Rajan WadhawanDepartment of Pediatrics, Florida Hospital for Children, Orlando, FL.
Lisa PalermoDepartment of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.
TOLSURF Study Group
University of California, San Francisco · USAdventHealth for Children · USNorthwestern University · USJohns Hopkins University · USMedical University of South Carolina · USUCSF Benioff Children's Hospital · USUniversity of Tennessee Health Science Center · USChildren's Mercy Hospital · USChildren’s Minnesota - St. Paul Hospital · USThe University of Texas Health Science Center at Houston · USBoston Children's Hospital · USUniversity of Arkansas for Medical Sciences · USUniversity of Florida · USUniversity of Minnesota System · USUniversity of Washington · USWake Forest University · US

Funding

Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
Trial of Late SURFactant (TOLSURF) to Prevent BPD - Clinical Coord CtrU01HL094338 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI BALLARD, ROBERTA ANDERSON · 2009 to 2013
$7.4M
Trial Of Late SURFactant (TOLSURF) to Prevent BPD-Data Coordinating CenterU01HL094355 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI BLACK, DENNIS M · 2009 to 2013
$1.2M
NCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1TR000004NHLBI NIH HHS U01 HL094338NHLBI NIH HHS U01-HL094338NHLBI NIH HHS U01 HL094355NHLBI NIH HHS U01HL094355
6 · The paper itself

Abstract

objectiveTo assess whether late surfactant treatment in extremely low gestational age (GA) newborn infants requiring ventilation at 7-14 days, who often have surfactant deficiency and dysfunction, safely improves survival without bronchopulmonary dysplasia (BPD). STUDY

designExtremely low GA newborn infants (GA ≤28 0/7 weeks) who required mechanical ventilation at 7-14 days were enrolled in a randomized, masked controlled trial at 25 US centers. All infants received inhaled nitric oxide and either surfactant (calfactant/Infasurf) or sham instillation every 1-3 days to a maximum of 5 doses while intubated. The primary outcome was survival at 36 weeks postmenstrual age (PMA) without BPD, as evaluated by physiological oxygen/flow reduction.

resultsA total of 511 infants were enrolled between January 2010 and September 2013. There were no differences between the treated and control groups in mean birth weight (701 ± 164 g), GA (25.2 ± 1.2 weeks), percentage born at GA <26 weeks (70.6%), race, sex, severity of lung disease at enrollment, or comorbidities of prematurity. Survival without BPD did not differ between the treated and control groups at 36 weeks PMA (31.3% vs 31.7%; relative benefit, 0.98; 95% CI, 0.75-1.28; P = .89) or 40 weeks PMA (58.7% vs 54.1%; relative benefit, 1.08; 95% CI, 0.92-1.27; P = .33). There were no between-group differences in serious adverse events, comorbidities of prematurity, or severity of lung disease to 36 weeks.

conclusionLate treatment with up to 5 doses of surfactant in ventilated premature infants receiving inhaled nitric oxide was well tolerated, but did not improve survival without BPD at 36 or 40 weeks. Pulmonary and neurodevelopmental assessments are ongoing.

trial registrationClinicalTrials.gov: NCT01022580.

Indexed as

Administration, InhalationBronchopulmonary DysplasiaFemaleHumansInfant, NewbornInfant, PrematureInfant, Premature, DiseasesInfant, Very Low Birth WeightMaleNitric OxidePulmonary SurfactantsRespiration, ArtificialSurvival RateUnited StatesNitric OxidePulmonary Surfactants

Identifiers

PMID26500107
PMCPMC4698022
OpenAlexW1958389389

What OpenQuestion holds

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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.