NCT02139800

Sustained Aeration of Infant Lungs Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 23 Weeks – 26 Weeks
• Healthy volunteers: Not accepted

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

Detailed description

The SAIL trial aims to provide evidence for changing policy or standard of care. The context of this trial is an unacceptable rate of poor long-term outcomes of preterm infants born as Extremely Low Gestational Age Newborns (ELGAN) \<1000 g birthweight (BW), but especially for those born between 23-26 weeks' gestational age (GA). Such infants are the most vulnerable and immature in all organ systems, including the lungs and the brain. These infants are at high risk of death and bronchopulmonary dysplasia (BPD) during their initial hospitalization, neurodevelopmental impairment (NDI) and pulmonary problems in infancy and childhood. The SAIL trial focuses on facilitating the difficult transition of these most vulnerable infants from a liquid filled in-utero lung to an ex-utero air-filled lung. Sustained Inflation (SI) is a promising delivery room (DR) intervention, with evidence of short-term efficacy with minimal risk of additional harm beyond current standard accepted Newborn Resuscitation Program (NRP) Guidelines. This protocol proposes a fully informed consenting procedure. We propose to evaluate the impact of a SI in the DR on the need for mechanical ventilation in the first week of life which would also impact mortality rates and the incidence and severity of BPD.

Conditions

• Preterm Birth
• Extreme Prematurity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-08-27
• Primary completion: 2018-02-15
• Completion: 2020-03-23
• First posted: 2014-05-15
• Last updated: 2023-04-06
• Results posted: 2020-06-25

Locations

21 sites across 9 countries: United States, Australia, Austria, Canada, Germany, Italy, Netherlands, Singapore, South Korea