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

NCT04792099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-01-26

No results posted yet for this study

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), 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.

Conditions

  • Infant, Newborn, Disease
  • Hypoxia
  • Respiratory Distress Syndrome
  • Bronchopulmonary Dysplasia

Interventions

PROCEDURE

Continuous positive airway pressure

After study entry, CPAP will be provided via mask or binasal prongs in order to have a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery. A PEEP of 5 will be used for uniformity.

PROCEDURE

Nasal Cannula

After study entry, flow will be set to 0.5 L/kg with 1L maximum while on NC during the study period to reduce the risk of inadvertent PEEP with higher flows. Initial FiO2 can be titrated to achieve target saturations, and may be increased up to 100% while on NC.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Waldemar A Carlo, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2023-03-29
Completion
2023-03-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04792099 on ClinicalTrials.gov