Evidence map›Paper›PMID 30340932›Full record

Trial reportThe Journal of pediatrics2019

PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age.

Ronald I Clyman, Melissa Liebowitz, Joseph Kaempf, Omer Erdeve, Ali Bulbul, Stellan Håkansson, Johanna Lindqvist, Aijaz Farooqi, Anup Katheria, Jason Sauberan and 16 more

2 registry-linked trialsOpen access · greenAbstract readPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 119 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
119citing papers in PubMed, 7 pooled it
18.3field-weighted citation impact, top 1% 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.

NCT01958320 phase2completednot on this map

Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2013 to 2017Enrolled202ConditionsPatent Ductus Arteriosus, Surgery, Necrotizing Enterocolitis, Intestinal PerforationArmspharmacologic treatment of the PDA, no pharmacologic treatment of the PDA, NSAID
NCT06064825 recruitingnot on this mapstarted 2023, after this paper: background citation

Long Term Follow-up of the TREOCAPA (Prophylactic TREatment Of the duCtus Arteriosus in Preterm Infants by Acetaminophen) Study (TREOCAPA-LT)

TypeobservationalSponsorInstitut National de la Santé Et de la Recherche Médicale, FranceRan2023 to 2027Enrolled500ConditionsPatency of the Ductus Arteriosus Acetaminophen Extreme PrematurityArms2 year follow-up of neurodevelopment using a parental questionnaire
3 · Its place in the literature

Who cites it

119 citing papers in PubMed, 7 syntheses or guidelines pooled it, 208 citations in OpenAlex.

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  3. Indomethacin for symptomatic patent ductus arteriosus in preterm infants.The Cochrane database of systematic reviews · 2021
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  14. Patent ductus arteriosus shunt elimination results in a reduction in adverse outcomes: a post hoc analysis of the PDA RCT cohort.Journal of perinatology : official journal of the California Perinatal Association · 2021
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59 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 20 institutions in 4 countries.

Ronald I ClymanDepartment of Pediatrics, University of California San Francisco, San Francisco, CA; Cardiovascular Research Institute, University of California San Francisco, San Francisco, CA. Electronic address: clymanr@peds.ucsf.edu.
Melissa LiebowitzDepartment of Pediatrics, University of California San Francisco, San Francisco, CA.
Joseph KaempfDepartment of Pediatrics, Providence St. Vincent Medical Center, Portland, OR.
Omer ErdeveDepartment of Pediatrics, Ankara University School of Medicine Children's Hospital, Ankara, Turkey.
Ali BulbulDepartment of Pediatrics, Sisli Hamidiye Etfal Training and Research Hospital, İstanbul, Turkey.
Stellan HåkanssonDepartment of Pediatrics, Umea University Hospital, Umea, Sweden.
Johanna LindqvistDepartment of Pediatrics, Umea University Hospital, Umea, Sweden.
Aijaz FarooqiDepartment of Pediatrics, Umea University Hospital, Umea, Sweden.
Anup KatheriaDepartment of Pediatrics, Sharp Mary Birch Hospital, San Diego, CA.
Jason SauberanDepartment of Pediatrics, Sharp Mary Birch Hospital, San Diego, CA.
Jaideep SinghDepartment of Pediatrics, University of Chicago, Chicago, IL.
Kelly NelsonDepartment of Pediatrics, University of Chicago, Chicago, IL.
Andrea WickremasingheDepartment of Pediatrics, Kaiser Permanente Santa Clara Medical Center, Santa Clara, CA.
Lawrence DongDepartment of Pediatrics, Kaiser Permanente Santa Clara Medical Center, Santa Clara, CA.
Denise C HassingerDepartment of Pediatrics, Morristown Medical Center, Morristown, NJ.
Susan W AucottDepartment of Pediatrics, Johns Hopkins University, Baltimore, MD.
Madoka HayashiDepartment of Pediatrics, Johns Hopkins University, Baltimore, MD.
Anne Marie HeuchanDepartment of Pediatrics, University of Glasgow, Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom.
William A CareyDepartment of Pediatrics, Mayo Clinic, Rochester, MN.
Matthew DerrickDepartment of Pediatrics, Northshore University Health System, Evanston, IL.
Erika FernandezDepartment of Pediatrics, University of California San Diego and Rady Children's Hospital, San Diego, CA.
Meera SankarDepartment of Pediatrics, Good Samaritan Hospital, San Jose, CA.
Tina LeoneDepartment of Pediatrics, Columbia University Medical Center, New York, NY.
Jorge PerezDepartment of Pediatrics, South Miami Hospital/Baptist Health South Florida, Miami, FL.
Arturo SerizeDepartment of Pediatrics, South Miami Hospital/Baptist Health South Florida, Miami, FL.
PDA-TOLERATE (PDA: TO LEave it alone or Respond And Treat Early) Trial Investigators
University of California San Diego · USAnkara University · TRMayo Clinic in Arizona · USRoyal Hospital for Children · GBSharp Mary Birch Hospital for Women & Newborns · USUniversity of California, San Francisco · USUniversity of Chicago · USBaptist Hospital of Miami · USColumbia University Irving Medical Center · USNorthShore University HealthSystem · USProvidence St. Vincent Medical Center · USUmeå University · SEGood Samaritan Hospital · USJohns Hopkins University · USKaiser Permanente Santa Clara Medical Center · USMorristown Medical Center · USŞişli Etfal Eğitim ve Araştırma Hastanesi · TRJohns Hopkins Hospital · USUniversity of Southern California · USVanderbilt University · US

Funding

Clinical and Translational Science InstituteUL1TR001872 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI COLLARD, HAROLD R, JACOBY, VANESSA · 2016 to 2025
$112.1M
Clinical and Translational Science AwardUL1TR001873 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI REILLY, MUREDACH P · 2016 to 2025
$99.0M
Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
Genes contributing to patent ductus arteriosus susceptibility in preterm newbornsR01HL109199 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CLYMAN, RONALD I · 2011 to 2014
$3.0M
Ductus Arteriosus Regulation by Anion ChannelsR01HL128386 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI LAMB, FRED S, REESE, JOHN JEFFREY · 2016 to 2019
$2.3M
NCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1 TR001872NCATS NIH HHS UL1 TR001873NHLBI NIH HHS R01 HL109199NHLBI NIH HHS R01 HL128386
6 · The paper itself

Abstract

objectiveTo compare early routine pharmacologic treatment of moderate-to-large patent ductus arteriosus (PDA) at the end of week 1 with a conservative approach that requires prespecified respiratory and hemodynamic criteria before treatment can be given. STUDY

designA total of 202 neonates of <28 weeks of gestation age (mean, 25.8 ± 1.1 weeks) with moderate-to-large PDA shunts were enrolled between age 6 and 14 days (mean, 8.1 ± 2.2 days) into an exploratory randomized controlled trial.

resultsAt enrollment, 49% of the patients were intubated and 48% required nasal ventilation or continuous positive airway pressure. There were no differences between the groups in either our primary outcome of ligation or presence of a PDA at discharge (early routine treatment [ERT], 32%; conservative treatment [CT], 39%) or any of our prespecified secondary outcomes of necrotizing enterocolitis (ERT, 16%; CT, 19%), bronchopulmonary dysplasia (BPD) (ERT, 49%; CT, 53%), BPD/death (ERT, 58%; CT, 57%), death (ERT,19%; CT, 10%), and weekly need for respiratory support. Fewer infants in the ERT group met the rescue criteria (ERT, 31%; CT, 62%). In secondary exploratory analyses, infants receiving ERT had significantly less need for inotropic support (ERT, 13%; CT, 25%). However, among infants who were ≥26 weeks gestational age, those receiving ERT took significantly longer to achieve enteral feeding of 120 mL/kg/day (median: ERT, 14 days [range, 4.5-19 days]; CT, 6 days [range, 3-14 days]), and had significantly higher incidences of late-onset non-coagulase-negative Staphylococcus bacteremia (ERT, 24%; CT,6%) and death (ERT, 16%; CT, 2%).

conclusionsIn preterm infants age <28 weeks with moderate-to-large PDAs who were receiving respiratory support after the first week, ERT did not reduce PDA ligations or the presence of a PDA at discharge and did not improve any of the prespecified secondary outcomes, but delayed full feeding and was associated with higher rates of late-onset sepsis and death in infants born at ≥26 weeks of gestation.

trial registrationClinicalTrials.gov: NCT01958320.

Indexed as

Conservative TreatmentAcetaminophenContinuous Positive Airway PressureCyclooxygenase InhibitorsDuctus Arteriosus, PatentFemaleGestational AgeHumansIbuprofenIndomethacinInfant, Extremely PrematureInfant, NewbornMaleProspective StudiesSingle-Blind MethodTreatment OutcomeAcetaminophenCyclooxygenase InhibitorsIbuprofenIndomethacinbronchopulmonary dysplasianecrotizing enterocolitisnewbornpremature birthretinopathy of prematurity

Identifiers

PMID30340932
PMCPMC6502709
OpenAlexW2897109737

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.