Evidence map›Paper›PMID 23037875›Full record

Trial reportPediatric research2012

Late administration of surfactant replacement therapy increases surfactant protein-B content: a randomized pilot study.

Roberta L Keller, Jeffrey D Merrill, Dennis M Black, Robin H Steinhorn, Eric C Eichenwald, David J Durand, Rita M Ryan, William E Truog, Sherry E Courtney, Philip L Ballard and 1 more

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

Trial report in Pediatric research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00569530 (Trial of Late Surfactant to Prevent BPD), 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
1.5field-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.

NCT00569530 phase3completednot on this map

Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide

TypeinterventionalSponsorRoberta BallardRan2008 to 2012Enrolled85ConditionsRespiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), Bronchopulmonary DysplasiaArmsInfasurf (ONY Inc.), Sham
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Use of surfactant beyond respiratory distress syndrome, what is the evidence?Journal of perinatology : official journal of the California Perinatal Association · 2024
    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. Review
  10. 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 2 countries.

Roberta L KellerDepartment of Pediatrics, University of California, San Francisco, San Francisco, California, USA. kellerr@peds.ucsf.edu
Jeffrey D Merrill
Dennis M Black
Robin H Steinhorn
Eric C Eichenwald
David J Durand
Rita M Ryan
William E Truog
Sherry E Courtney
Philip L Ballard
Roberta A Ballard
University of California, San Francisco · USOaklands Hospital · GBChildren's Mercy Hospital · USLurie Children's Hospital · USMedical University of South Carolina · USStony Brook University Hospital · USUniversity of Houston · US

Funding

UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024131 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$111.2M
World Trade Center Worker and Volunteer Medical Screening ProgramM01RR010710 · NCRR · STATE UNIVERSITY NEW YORK STONY BROOK · PI BAHOU, WADIE F · 1998 to 2009
$17.6M
Chronic Sildenafil for Severe Diaphragmatic HerniaK23HL079922 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KELLER, ROBERTA L · 2005 to 2009
$602k
NCRR NIH HHS M01 RR10710NCRR NIH HHS UL1 RR024131NCRR NIH HHS UL RR024131NHLBI NIH HHS K23HL079922
6 · The paper itself

Abstract

backgroundSurfactant dysfunction may contribute to the development of bronchopulmonary dysplasia (BPD) in persistently ventilated preterm infants. We conducted a multicenter randomized, blinded, pilot study to assess the safety and efficacy of late administration of doses of a surfactant protein-B (SP-B)-containing surfactant (calfactant) in combination with prolonged inhaled nitric oxide (iNO) in infants ≤1,000 g birth weight (BW).

methodsWe randomized 85 preterm infants ventilated at 7-14 d after birth to receive either late administration of surfactant (up to 5 doses) plus prolonged iNO or iNO alone. Large aggregate surfactant was isolated from daily tracheal aspirates (TAs) for measurement of SP-B content, total protein, and phospholipid (PL).

resultsLate administration of surfactant had minimal acute adverse effects. Clinical status as well as surfactant recovery and SP-B content in tracheal aspirate were transiently improved as compared to the controls; these effects waned after 1 d. The change in SP-B content with surfactant dosing was positively correlated with SP-B levels during treatment (r = 0.50, P = 0.02).

conclusionLow SP-B values increased with calfactant administration, but the relationship of this response to SP-B levels suggests that degradation is a contributing mechanism for SP-B deficiency and surfactant dysfunction. We conclude that late therapy with surfactant in combination with iNO is safe and transiently increases surfactant SP-B content, possibly leading to improved short- and long-term respiratory outcomes.

Indexed as

HumansInfant, NewbornInfant, PrematurePilot ProjectsPulmonary Surfactant-Associated Protein BPulmonary SurfactantsPulmonary Surfactant-Associated Protein BPulmonary Surfactants

Identifiers

PMID23037875
PMCPMC3548137
OpenAlexW2044540845

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.