Sustained Aeration of Infant Lungs Trial
Condition: Preterm Birth; Extreme Prematurity
MeSH terms: Premature Birth
Study type: Interventional

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.
    

Intervention name(s): Sustained Inflation; Standard of Care
Intervention type(s): Procedure; Procedure
Intervention description(s): The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds; Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neonatal resuscitation; Extreme Low Gestational Age Newborn (ELGAN); Delivery Room; Continuous positive airway pressure (CPAP); Positive pressure ventilation (PPV); Sustained inflation