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

NCT ID: NCT04792099

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2023-03-29

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..

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continuous positive airway pressure

Continuous positive airway pressure (CPAP) with blended oxygen delivered by binasal prongs or nasal mask.

Group Type: EXPERIMENTAL

Continuous positive airway pressure

Intervention Type: PROCEDURE

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.

Nasal Cannula

Blended oxygen delivered by nasal cannula (NC).

Group Type: ACTIVE_COMPARATOR

Nasal Cannula

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

CPAP; NC

Eligibility Criteria

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

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Siamak Yazdi

Principal Investigator, Neonatology Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waldemar A Carlo, MD

Role: STUDY_DIRECTOR

University of Alabama at Birmingham

Locations

UAB Hospital

Birmingham, Alabama, United States

Countries

United States

References

Yazdi S, Carlo WA, Nakhmani A, Boateng EO, Aban I, Ambalavanan N, Travers CP. Extended CPAP or low-flow nasal cannula for intermittent hypoxaemia in preterm infants: a 24-hour randomised clinical trial. Arch Dis Child Fetal Neonatal Ed. 2024 Aug 16;109(5):557-561. doi: 10.1136/archdischild-2023-326605.

Reference Type: DERIVED

PMID: 38365446 (View on PubMed)

Other Identifiers

UAB Neo ZY 2021

Identifier Type: -

Identifier Source: org_study_id