Evidence map›Paper›PMID 34112722›Full record

ArticleArchives of disease in childhood. Fetal and neonatal edition2022

Trial of aerosolised surfactant for preterm infants with respiratory distress syndrome.

Luke Jardine, Kei Lui, Helen G Liley, Timothy Schindler, James Fink, Jeanette Asselin, David Durand

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Archives of disease in childhood. Fetal and neonatal edition, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.7field-weighted citation impact, top 6% 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

11 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. What is new in synthetic lung surfactant protein technology?Expert review of respiratory medicine · 2024
    Article
  6. Moving on from clinical animal-derived surfactants to peptide-based synthetic pulmonary surfactant.American journal of physiology. Lung cellular and molecular physiology · 2024
    Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. 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

7 authors at 4 institutions in 5 countries.

Luke JardineNeonatology, Mater Mothers' Hospital, Brisbane, Queensland, Australia.
Kei LuiNewborn Care, The Royal Hospital for Women Newborn Intensive Care Unit, Randwick, New South Wales, Australia.
Helen G LileyNeonatology, Mater Mothers' Hospital, Brisbane, Queensland, Australia.
Timothy SchindlerNewborn Care, The Royal Hospital for Women Newborn Intensive Care Unit, Randwick, New South Wales, Australia.ORCID http://orcid.org/0000-0003-2091-9308
James FinkAerogen Pharma, San Mateo, California, USA.
Jeanette AsselinAerogen Pharma, San Mateo, California, USA.
David DurandNeonatology, UCSF Benioff Children's Hospital Oakland, Oakland, California, USA ddurand53@gmail.com.ORCID http://orcid.org/0000-0003-1181-0941
Aerogen (Ireland) · IERoyal Hospital for Women · AUThe University of Queensland · AUUCSF Benioff Children's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the safety of an aerosolised surfactant, SF-RI 1, administered via nasal continuous positive airway pressure (nCPAP) and a prototype breath synchronisation device (AeroFact), to preterm infants with respiratory distress syndrome (RDS).

designMulticentre, open-label, dose-escalation study with historical controls.

settingNewborn intensive care units at Mater Mothers' Hospital, Brisbane, and Royal Hospital for Women, Sydney, Australia. PATIENTS: Infants 26 weeks through 30 weeks gestation who required nCPAP 6-8 cmH

interventionsIn part 1, infants received a single dose of 216 mg/kg of aerosolised surfactant. In part 2, infants could receive up to four doses of aerosolised surfactant. Three historical control infants were matched for each enrolled infant.

main outcome measuresTreatment failure was defined as Respiratory Severity Score (FiO

results10 infants were enrolled in part 1 and 21 in part 2 and were compared with 93 historical controls. No safety issues were identified. In part 2, 6 of 21 (29%) AeroFact-treated infants compared with 30 of 63 (48%) control infants met failure criteria. Kaplan-Meier analysis of patients in part 2 showed a trend towards decreased rate of study failure in the AeroFact-treated infants compared with historical controls (p=0.10).

conclusionThe AeroFact system can safely deliver aerosolised surfactant to preterm infants with RDS who are on nCPAP. TRIAL REGISTRATION NUMBER: ACTRN12617001458325.

Indexed as

Continuous Positive Airway PressureDrug Delivery SystemsAerosolsFemaleGestational AgeHumansInfant, NewbornInfant, PrematureMalePhospholipidsPilot ProjectsPulmonary SurfactantsRespiratory Distress Syndrome, NewbornTreatment FailureAerosolsPhospholipidsPulmonary SurfactantsSF-RI 1, bovine surfactant preparationneonatologytherapeutics

Identifiers

PMID34112722
PMCPMC8685619
OpenAlexW3172358300

What OpenQuestion holds

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LicenceCC BY-NC
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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.