Evidence map›Paper›PMID 31086287›Full record

Trial reportPediatric research2019

The role of recombinant human CC10 in the prevention of chronic pulmonary insufficiency of prematurity.

Jonathan M Davis, Aprile L Pilon, Jeffrey Shenberger, Janis L Breeze, Norma Terrin, Jan Mazela, Ewa Gulczynska, Ryszard Lauterbach, Richard Parad

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pediatric research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.4field-weighted citation impact, top 17% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. CC16 Binding to αAmerican journal of respiratory and critical care medicine · 2021
    Article
  9. New Pharmacologic Approaches to Bronchopulmonary Dysplasia.Journal of experimental pharmacology · 2021
    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

9 authors at 6 institutions in 2 countries.

Jonathan M DavisDepartment of Pediatrics, The Floating Hospital for Children at Tufts Medical Center, Boston, MA, USA. jdavis@tuftsmedicalcenter.org.
Aprile L PilonTherabron Therapeutics, Inc, Rockville, MD, USA.
Jeffrey ShenbergerBaystate Children's Hospital, Springfield, MA, USA.
Janis L BreezeTufts Clinical and Translational Science Institute, Tufts University, and the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.
Norma TerrinTufts Clinical and Translational Science Institute, Tufts University, and the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.
Jan MazelaGinekologiczno-Położniczy Szpital Kliniczny UM, Poznan, Poland.
Ewa GulczynskaInstytut Centrum Zdrowia Matki Polski, Lodz, Poland.
Ryszard LauterbachSamodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Krakow, Poland.
Richard ParadDepartment of Pediatric Newborn Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Tufts University · USBaystate Medical Center · USBrigham and Women's Hospital · USPolish Mother’s Memorial Hospital Research Institute · PLSzpital Uniwersytecki w Krakowie · PLTufts Medical Center · US

Funding

Tufts Clinical and Translational Research InstituteUL1TR001064 · NCATS · TUFTS UNIVERSITY BOSTON · PI SELKER, HARRY P. · 2013 to 2017
$26.4M
FDA HHS R01 FD003899NCATS NIH HHS UL1 TR001064
6 · The paper itself

Abstract

backgroundPreterm neonates can develop chronic pulmonary insufficiency of prematurity (CPIP) later in infancy. Recombinant human CC10 protein (rhCC10) is an anti-inflammatory agent that could potentially prevent CPIP.

methodsThe safety and efficacy of a single intratracheal dose of rhCC10 in reducing CPIP at 12 months corrected gestational age (CGA) was evaluated in a Phase II double-blind, randomized, placebo-controlled, multisite clinical trial. Eighty-eight neonates were randomized: 22 to placebo and 22 to 1.5 mg/kg rhCC10 in the first cohort and 21 to placebo and 23 to 5 mg/kg rhCC10 in the second cohort. Neonates were followed to 12 months CGA.

resultsWith CPIP defined as signs/symptoms, medical visits, hospital readmissions, and use of medications for respiratory complications at 12 months CGA, no significant differences were observed between rhCC10 or placebo groups. Only 5% of neonates had no evidence of CPIP at 12 months CGA.

conclusionsA single dose of rhCC10 was not effective in reducing CPIP at 12 CGA. Since most neonates had evidence of CPIP using these exploratory endpoints, it is essential to develop more robust outcome measures for clinical trials of respiratory medications in high-risk premature neonates.

Indexed as

Anti-Inflammatory AgentsChronic DiseaseDouble-Blind MethodFemaleGenetic Predisposition to DiseaseGestational AgeHumansInfant, NewbornInfant, PrematureInfant, Premature, DiseasesLungLung DiseasesMalePatient ReadmissionPatient SafetyPulmonary SurfactantsAnti-Inflammatory AgentsPulmonary SurfactantsRecombinant ProteinsSCGB1A1 protein, humanUteroglobin

Identifiers

PMID31086287
PMCPMC9487981
OpenAlexW2945447931

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.