Status:
COMPLETED
CPAP Or Nasal Cannula Oxygen for Preterm Infants: A Randomized Controlled Trial
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Infant, Newborn, Disease
Hypoxia
Eligibility:
All Genders
Phase:
NA
Brief Summary
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), CPA...
Detailed Description
We hope to determine whether in preterm infants \< 34 weeks' gestation at birth receiving respiratory support with continuous positive airway pressure (CPAP) or nasal cannula (NC), CPAP compared with ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04792099
Start Date
August 16 2021
End Date
March 29 2023
Last Update
January 26 2024
Active Locations (1)
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1
UAB Hospital
Birmingham, Alabama, United States, 35233