Evidence map›Paper›PMID 28100402›Full record

Trial reportThe Journal of pediatrics2017

The Randomized, Controlled Trial of Late Surfactant: Effects on Respiratory Outcomes at 1-Year Corrected Age.

Roberta L Keller, Eric C Eichenwald, Anna Maria Hibbs, Elizabeth E Rogers, Katherine C Wai, Dennis M Black, Philip L Ballard, Jeanette M Asselin, William E Truog, Jeffrey D Merrill and 18 more

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

Trial report in The Journal of pediatrics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01022580 (Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% 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)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Use of surfactant beyond respiratory distress syndrome, what is the evidence?Journal of perinatology : official journal of the California Perinatal Association · 2024
    Review
  6. Review
  7. Comparative efficacy and safety of late surfactant preparations: a retrospective study.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Article
  8. Article
  9. Bronchopulmonary dysplasia.Nature reviews. Disease primers · 2019
    Review
  10. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors at 16 institutions in 1 country.

Roberta L KellerDepartment of Pediatrics, University of California San Francisco, San Francisco, CA. Electronic address: kellerr@peds.ucsf.edu.
Eric C EichenwaldDepartment of Pediatrics, University of Texas, Houston, TX.
Anna Maria HibbsDepartment of Pediatrics, Case Western Reserve University, Cleveland, OH.
Elizabeth E RogersDepartment of Pediatrics, University of California San Francisco, San Francisco, CA.
Katherine C WaiUniversity of California San Francisco School of Medicine, San Francisco, CA.
Dennis M BlackDepartment of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.
Philip L BallardDepartment of Pediatrics, University of California San Francisco, San Francisco, CA.
Jeanette M AsselinDepartment of Pediatrics, Benioff Children's Hospital Oakland, Oakland, CA.
William E TruogDepartment of Pediatrics, Children's Mercy Hospital, Kansas City, MO.
Jeffrey D MerrillDepartment of Pediatrics, Benioff Children's Hospital Oakland, Oakland, CA.
Mark C MammelDepartment of Pediatrics, Children's Hospital and Clinics of Minnesota, St Paul and Minneapolis, MN.
Robin H SteinhornDepartment of Pediatrics, Children's National Medical Center, Washington, DC.
Rita M RyanDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
David J DurandDepartment of Pediatrics, Benioff Children's Hospital Oakland, Oakland, CA.
Catherine M BendelDepartment of Pediatrics, University of Minnesota, Minneapolis, MN.
Ellen M Bendel-StenzelDepartment of Pediatrics, Children's Hospital and Clinics of Minnesota, St Paul and Minneapolis, MN.
Sherry E CourtneyDepartment of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR.
Ramasubbareddy DhanireddyDepartment of Pediatrics, University of Tennessee Health Science Center, Memphis, TN.
Mark L HudakDepartment of Pediatrics, University of Florida College of Medicine, 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.
Jennifer HeldermanDepartment of Pediatrics, Wake Forest School of Medicine/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.
Roberta A BallardDepartment of Pediatrics, University of California San Francisco, San Francisco, CA.
TOLSURF Study Group
University of California, San Francisco · USUCSF Benioff Children's Hospital · USChildren’s Minnesota - St. Paul Hospital · USMedical University of South Carolina · USAdventHealth for Children · USCase Western Reserve University · USChildren's Mercy Hospital · USChildren's National · USJohns Hopkins University · USNorthwestern University · USNovant Health Forsyth Medical Center · USUniversity of Arkansas for Medical Sciences · USUniversity of Florida · USUniversity of Minnesota · USUniversity of Tennessee Health Science Center · USUniversity of Washington · 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 TR000004NHLBI NIH HHS U01 HL094338NHLBI NIH HHS U01 HL094355
6 · The paper itself

Abstract

objectiveTo determine the effects of late surfactant on respiratory outcomes determined at 1-year corrected age in the Trial of Late Surfactant (TOLSURF), which randomized newborns of extremely low gestational age (≤28 weeks' gestational age) ventilated at 7-14 days to late surfactant and inhaled nitric oxide vs inhaled nitric oxide-alone (control). STUDY

designCaregivers were surveyed in a double-blinded manner at 3, 6, 9, and 12 months' corrected age to collect information on respiratory resource use (infant medication use, home support, and hospitalization). Infants were classified for composite outcomes of pulmonary morbidity (no PM, determined in infants with no reported respiratory resource use) and persistent PM (determined in infants with any resource use in ≥3 surveys).

resultsInfants (n = 450, late surfactant n = 217, control n = 233) were 25.3 ± 1.2 weeks' gestation and 713 ± 164 g at birth. In the late surfactant group, fewer infants received home respiratory support than in the control group (35.8% vs 52.9%, relative benefit [RB] 1.28 [95% CI 1.07-1.55]). There was no benefit of late surfactant for No PM vs PM (RB 1.27; 95% CI 0.89-1.81) or no persistent PM vs persistent PM (RB 1.01; 95% CI 0.87-1.17). After adjustment for imbalances in baseline characteristics, relative benefit of late surfactant treatment increased: RB 1.40 (95% CI 0.89-1.80) for no PM and RB 1.24 (95% CI 1.08-1.42) for no persistent PM.

conclusionTreatment of newborns of extremely low gestational age with late surfactant in combination with inhaled nitric oxide decreased use of home respiratory support and may decrease persistent pulmonary morbidity.

trial registrationClinicalTrials.gov: NCT01022580.

Indexed as

Infant, Extremely Low Birth WeightAdministration, InhalationAge FactorsBronchopulmonary DysplasiaConfidence IntervalsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesGestational AgeHumansInfantInfant, NewbornMaleNitric OxideNitric OxidePulmonary Surfactantsbronchopulmonary dysplasiaprematuritypulmonary morbiditywheeze

Identifiers

PMID28100402
PMCPMC5367937
OpenAlexW2573252533

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.