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