CPAP Or Nasal Cannula Oxygen for Preterm Infants: A Randomized Controlled Trial

Completed · Not applicable

Conditions studied: Infant, Newborn, Disease, Hypoxia, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia

In brief

The purpose of this study is to determine if in preterm infants \< 34 weeks' gestation at birth receiving respiratory support with continuous positive airway pressure (CPAP) or nasal cannula (NC), CPAP compared with NC will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 24-hour randomized controlled trial. This will be a randomized controlled trial with a 1:1 parallel allocation of infants to CPAP or NC oxygen using stratified permuted block design.

Key facts

Study ID

NCT04792099

Run by

University of Alabama at Birmingham

People needed

38

Starts

2021-08-16

Expected to finish

2023-03-29

Last updated by the study team

2024-01-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants must be currently utilizing CPAP (without a rate) with a PEEP ≤ 5 and FiO2 ≤ 30%
• Infants must meet CPAP stability criteria as follow:
• If previously intubated, must be extubated ≥ 72 hours
• < 3 self-resolving apneas (≤ 20 s) and/or bradycardia (< 100 bpm) in any hour over previous 6 hours)
• Gestational age < 34 weeks' gestation at birth
• Informed consent by parents/legal guardians

You may not qualify if…

• presence of a major malformation
• a neuromuscular condition that affects respiration
• a terminal illness or decision to withhold or limit support
• currently being treated for sepsis
• enrollment in a competing trial

Where it is running

• UAB Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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