The Sustained Aeration of Infant Lungs Study

Phase 3

Completed

• Conditions: bronchopulmonary dysplasia; chronic lung disease; 10057167; 10028971

• Registration Number: NL-OMON45135
• Lead Sponsor: ational Institute of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Infants born in participating Neonatal Intensive Care Units
Gestational Age at least 23 weeks but less than 27 completed weeks
requiring resuscitation/respiratory intervention at birth

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of death or bronchopulmonary dysplasia at 36 weeks gestation age. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Need for mechanical ventilation in the first 7 days of life<br /><br>Need for surfactant<br /><br>Neurodevelopment outcomes at 22-26 months of corrected age<br /><br>Respiratory outcome at 22-26 months of corrected age</p><br>