Sustained Aeration of Infant Lungs Trial

Status:	Active, not recruiting
Conditions:	Women's Studies
Therapuetic Areas:	Reproductive
Healthy:	No
Age Range:	Any
Updated:	9/19/2018
Start Date:	August 27, 2014
End Date:	March 23, 2020

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

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.

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

We found this trial at

sites

Hospital of the Univerity of Pennsylvania

Philadelphia, Pennsylvania 19104

Principal Investigator: Elizabeth Foglia, MD

Phone: 215-917-2322

from

Philadelphia, PA