The SAINT Trial: Surfactant by supraglottic Airway versus direct laryngoscopy IN late preterm and Term newborns

Phase 3

Recruiting

• Conditions: Respiratory Distress Syndrome; Respiratory - Other respiratory disorders / diseases; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12619000995178
• Lead Sponsor: Women's and Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-12
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

Infants are eligible for inclusion in the study if:
•They are born at >33 weeks GA by best obstetric estimate and have a birth weight of >1500g; and
•They are <24 hours old at the time of randomisation; and
•They require nasal continuous positive airway pressure (nCPAP) after admission for moderate-to-severe respiratory distress, hypoxia or hypercapnia where the treating clinician has determined surfactant therapy is indicated and it is felt unlikely ongoing mechanical ventilation is required.

Exclusion Criteria

Infants are excluded from the trial if:
•They have a known major congenital abnormality that may impact on the infants’ condition (including complex congenital cardiac disease, upper airway obstruction or complex airway abnormality, gastro-intestinal malformation; and
•They have previously been intubated (including intubation for suctioning below the cords in the delivery suite), or immediately need intubation, as a determined by the attending clinician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified