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

Not Applicable

Completed

• Conditions: Bronchopulmonary Dysplasia; Infant, Newborn, Disease; Respiratory Distress Syndrome; Hypoxia
• Interventions: Procedure: Continuous positive airway pressure; Procedure: Nasal Cannula

• Registration Number: NCT04792099
• Lead Sponsor: University of Alabama at Birmingham

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), 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.

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 NC will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 24-hour randomized controlled trial.

This study will include preterm infants \< 34 weeks' gestation on respiratory support via CPAP with a PEEP ≤ 5 and FiO2 ≤ 30%. There will be two randomization strata \[≥ 22+0/7 to ≤ 27+0/7 weeks, and ≥ 27+1/7 to ≤ 33+6/7 weeks. The purpose of stratification is to ensure an appropriate distribution of risk between study arms. This study will not be powered to detect outcome differences within or between strata.

Following informed consent, randomization, stratified by gestational age at delivery, will be performed using sequentially numbered sealed opaque envelopes. Each envelope will indicate either Treatment group (CPAP group) or Control group (NC group). The envelope will only be opened after informed consent has been obtained and just before starting the study on each infant.

This will be a single center randomized controlled trial with a 1:1 parallel allocation of infants to CPAP or NC oxygen using stratified permuted block design. 15-30 minutes will be provided as a washout period at the beginning of the intervention, followed by 24 hours on the intervention. Infants enrolled must meet CPAP stability criteria that are based on prior randomized clinical trials of weaning from CPAP to NC.

All infants enrolled in the study will have routine monitoring, uniform target saturation ranges of 91-95% with alarm limits set at 88-95%, and standard care for the duration of the study. The high alarm limit will be increased to 100% if an infant is weaned to 21% FiO2. Supplemental FiO2 will be titrated per unit routine to achieve goal target saturations. Pulse oximetry recordings will be downloaded using ixTrend (iexcellence, Wildau, Germany) software to a secure computer system or via Bedmaster software for later data analysis. The target oxygen saturations (91 to 95%) are based on data from the meta-analysis of randomized controlled trials of oxygen saturation targets which included data on 4911 infants from the SUPPORT, COT, and BOOST II trials.

Primary and secondary outcomes are described below. Other safety outcomes include recordings of episodes of bradycardia and circumstances surrounding the event. Pulse oximetry recordings will be downloaded using ixTrend software to a secure computer system for later data analysis. Abdominal and cerebral NIRS will also be performed with subsequent data analysis..

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-10
• Study Start: 2021-08-16
• Primary Completion: 2023-03-29
• Study Completion: 2023-03-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous positive airway pressure	Continuous positive airway pressure	Continuous positive airway pressure (CPAP) with blended oxygen delivered by binasal prongs or nasal mask.
Nasal Cannula	Nasal Cannula	Blended oxygen delivered by nasal cannula (NC).

Primary Outcome Measures

Name	Time	Method
The number of episodes with oxygen saturations less than 85% for ≥ 10 seconds	24 hours of intervention

Secondary Outcome Measures

Name	Time	Method
The median transcutaneous carbon dioxide value	24 hours of intervention
The coefficient of variability of oxygen saturations (relative standard deviation)	24 hours of intervention	The coefficient of variation is a standardized measure of dispersion of a frequency distribution defined as the ratio of the standard deviation to the mean. It will be used in this study to assess the stability of oxygen saturations.
The number of episodes (≥ 10 seconds) with oxygen saturations less than 80 %	24 hours of intervention
The median aNIRS value	24 hours of intervention	Median abdominal near-infrared spectroscopy value during the 24 hour intervention period
The proportion of time spent outside oxygen saturation target ranges (91-95%) among infants requiring supplemental oxygen	24 hours of intervention
The proportion of time with oxygen saturations less than 85%	24 hours of intervention
The number of recorded episodes (≥ 10 seconds) of bradycardia < 100/min	24 hours of intervention
The proportion of time with oxygen saturations > 95 % among infants requiring supplemental oxygen	24 hours of intervention
The median supplemental oxygen concentration	24 hours of intervention
The median cNIRS value	24 hours of intervention	Median cerebral near-infrared spectroscopy value during the 24 hour intervention period

Trial Locations

Locations (1)

UAB Hospital; 🇺🇸 Birmingham, Alabama, United States