Sustained Aeration of Infant Lungs Trial

Summary

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

Conditions

• Preterm Birth
• Extreme Prematurity

Interventions

PROCEDURE

Sustained Inflation

The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds

PROCEDURE

Standard of Care

Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Haresh Kirpalani, BM, MSc · Children's Hospital of Philadelphia

• Peter Davis, MD, FRAXP · Royal Women's Hospital, Melbourne, Australia

• Helmut Hummler, MD · Children's Hospital, University of Ulm, Ulm Germany

• Martin Keszler, MD · Women & Infants Hospital of Rhode Island, Providence, RI

• GianLuca Lista, MD · Ospedale dei Bambini, Milan Italy

• Arjan te_Pas, MD · Leiden University Medical Center, Leiden, Netherlands

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

23 Weeks

Max Age

26 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-27

Primary Completion

2018-02-15

Completion

2020-03-23

Countries

• United States
• Australia
• Austria
• Canada
• Germany
• Italy
• Netherlands
• Singapore
• South Korea

Study Locations