Sustained Aeration of Infant Lungs Trial

Completed · Not applicable

Conditions studied: Preterm Birth, Extreme Prematurity

In brief

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

Key facts

Study ID

NCT02139800

Run by

University of Pennsylvania

People needed

460

Starts

2014-08-27

Expected to finish

2020-03-23

Last updated by the study team

2023-04-06

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age (GA) at least 23 weeks but less than 27 completed weeks by best obstetrical estimate
• Requiring resuscitation/respiratory intervention at birth -"apneic, labored breathing, gasping" (as defined in NRP 2011 AAP 6th Edition p.45)

You may not qualify if…

• Considered non-viable by the attending neonatologist
• Refusal of antenatal informed consent
• Known major anomalies, pulmonary hypoplasia
• Mothers who are unable to consent for their medical care and who do not have a surrogate guardian will not be approached for consent

Where it is running

• 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
• Mater Mother's Hospital — Brisbane, Queensland, Australia
• Royal Women's Hospital — Melbourne, Australia
• Academic Teaching Hospital, Landeskrankenhaus Feldkirch — Feldkirch, Austria
• Royal Alexandra Hospital, — Edmonton, Canada
• University of Freiburg — Freiburg im Breisgau, Germany
• Children's Hospital, University of Ulm — Ulm, Germany
• Ospedale dei Bambini — Milan, Italy
• Emma Children's Hospital, AMC — Amsterdam, Netherlands
• Leiden University Medical Center — Leiden, Netherlands
• KK Women's and Children's Hospital — Singapore, Singapore
• Seoul National University Children's Hospit — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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