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Clinical trialNCT02139800CompletedInterventional

Sustained Aeration of Infant Lungs Trial

SponsorUniversity of PennsylvaniaEnrollment460Extreme PrematurityPreterm Birth
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth which of two lung opening strategies - either a standard PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age. Hypotheses: 1. Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will reduce the need for mechanical ventilation in the first seven days of life, and reduce need for surfactant use; and 2. A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36 weeks post-menstrual age (PMA) than standard PEEP/CPAP

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Mater Mother'S Hospital

    Brisbane, Queensland, Australia

  • Royal Women'S Hospital

    Melbourne, Australia

Austria
  • Academic Teaching Hospital, Landeskrankenhaus Feldkirch

    Feldkirch, Austria

Canada
  • Royal Alexandra Hospital,

    Edmonton, Canada

Germany
  • University of Freiburg

    Freiburg im Breisgau, Germany

  • Children'S Hospital, University of Ulm

    Ulm, Germany

Italy
  • Ospedale Dei Bambini

    Milan, Italy

Netherlands
  • Emma Children'S Hospital, Amc

    Amsterdam, Netherlands

  • Leiden University Medical Center

    Leiden, Netherlands

Singapore
  • Kk Women'S and Children'S Hospital

    Singapore, Singapore

South Korea
  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Children'S Hospit

    Seoul, South Korea

United States
  • Loma Linda University

    Loma Linda, California, United States

  • University of California, Davis Children'S Hospital

    Sacramento, California, United States

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California, United States

  • Christiana Care

    Newark, Delaware, United States

  • University of Michigan

    Ann Arbor, Michigan, United States

  • Wake Med Health

    Raleigh, North Carolina, United States

  • Hospital of the Univerity of Pennsylvania

    Philadelphia, Pennsylvania, United States

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, United States

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
27 Aug 2014
Primary completion
15 Feb 2018
Completion
23 Mar 2020
Last update posted
6 Apr 2023
Registered enrollment
460
Registry id
NCT02139800

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.