Evidence map›Paper›PMID 30580975›Full record

ArticleThe Journal of pediatrics2019

Surfactant Administration in Preterm Infants: Drug Development Opportunities.

Genevieve Taylor, Wesley Jackson, Christoph P Hornik, Alec Koss, Sreekar Mantena, Kenya Homsley, Blair Gattis, Menefese Kudumu-Clavell, Reese Clark, P Brian Smith and 1 more

Open access · greenAbstract read
In one paragraph

Article in The Journal of pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.0field-weighted citation impact, top 12% 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

12 citing papers in PubMed, 20 citations in OpenAlex.

  1. Comparison of efficacy between beractant and poractant alfa in respiratory distress syndrome among preterm infants (28-33Journal of perinatology : official journal of the California Perinatal Association · 2025
    Trial
  2. Observational
  3. Article
  4. Article
  5. Article
  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. Review
  8. Comparative efficacy and safety of late surfactant preparations: a retrospective study.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Article
  9. Observational
  10. Article
  11. Article
  12. Why, when, and how to give surfactant.Pediatric research · 2019
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Genevieve TaylorDepartment of Pediatrics, The University of North Carolina, Chapel Hill, NC. Electronic address: genevieve.taylor@unchealth.unc.edu.
Wesley JacksonDepartment of Pediatrics, The University of North Carolina, Chapel Hill, NC.
Christoph P HornikDuke Clinical Research Institute, Duke University Medical Center, Durham, NC; Department of Pediatrics, Duke University Medical Center, Durham, NC.
Alec KossDuke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Sreekar MantenaDuke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Kenya HomsleyDuke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Blair GattisDuke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Menefese Kudumu-ClavellDuke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Reese ClarkPediatrix-Obstetrix Center for Research and Education, Sunrise, FL.
P Brian SmithDuke Clinical Research Institute, Duke University Medical Center, Durham, NC; Department of Pediatrics, Duke University Medical Center, Durham, NC.
Matthew M LaughonDepartment of Pediatrics, The University of North Carolina, Chapel Hill, NC.
Clinical Research Institute · USUniversity of North Carolina at Chapel Hill · US

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Safety of furosemide in premature infants at risk of bronchopulmonary dysplasiaR01FD005101 · FDA · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2016 to 2018
$1.1M
Echocardiogram to Diagnose Pulmonary Hypertension in Premature InfantsR34HL124038 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2015 to 2016
$719k
PATIENT SAFETY RESEARCH DURING NEONATAL CARE (R21)R21HD080606 · NICHD · DUKE UNIVERSITY · PI SMITH, PHILLIP BRIAN · 2015 to 2016
$457k
FDA HHS R01 FD005101NCATS NIH HHS UL1 TR001117NHLBI NIH HHS R34 HL124038NIAAA NIH HHS HHSN275201000003CNICHD NIH HHS HHSN267200700051CNICHD NIH HHS HHSN275201000003INICHD NIH HHS R21 HD080606NIDDK NIH HHS HHSN267200700051C
6 · The paper itself

Abstract

objectiveTo evaluate how frequently surfactant is used off-label in preterm infants. STUDY

designWe conducted a retrospective cohort analysis of prospectively collected administrative data for 2005-2015 from 348 neonatal intensive care units in the US. We quantified off-label administration of poractant alfa, calfactant, or beractant in inborn infants born at <37 weeks of gestational age (GA). Off-label surfactant administration was defined according to the Food and Drug Administration (FDA) label.

resultsOf a total of 110 822 preterm infants who received surfactant, 68 226 (62%) received the surfactant off-label. The majority of infants who received surfactant off-label had a higher birth weight than those who received surfactant on-label (40 716 [37%]), had an older GA than those who received surfactant on-label (35 191 [32%]), or were treated with intubation and surfactant administration followed by immediate extubation (INSURE) (32 310 [29%]). Poractant alfa was administered via INSURE more frequently than beractant or calfactant (16 688 [38%], 7137 [20%], and 8485 [27%], respectively). An increasing number of infants received surfactant via INSURE from 2005 to 2015 (from 1697 [19%] to 3368 [36%]).

conclusionsThe majority of surfactant given to preterm infants is administered off-label. The uptrend in administration via INSURE coincides with increased supporting evidence. The gap between FDA labeling and current clinic practice exemplifies an opportunity for label expansion, which may require additional prospective or retrospective safety and/or effectiveness data for infants of older GA and higher birth weight.

Indexed as

Intensive Care, NeonatalBiological ProductsBirth WeightDrug IndustryDrug LabelingElectronic Health RecordsFemaleGestational AgeHumansInfant, NewbornInfant, PrematureInfant, Premature, DiseasesMaleOff-Label UsePhospholipidsPulmonary SurfactantsberactantBiological ProductscalfactantPhospholipidsporactant alfaPulmonary Surfactantsdrug developmentsurfactant

Identifiers

PMID30580975
PMCPMC6486873
OpenAlexW2906459187

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.