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

NCT04792099 | Completed DMC

• 1 other identifier: UAB Neo ZY 2021
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The number of episodes with oxygen saturations less than 85% for ≥ 10 seconds

  24 hours of intervention

Secondary Outcomes (10)

• The coefficient of variability of oxygen saturations (relative standard deviation)

  24 hours of intervention

• The proportion of time with oxygen saturations > 95 % among infants requiring supplemental oxygen

  24 hours of intervention

• 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 median supplemental oxygen concentration

  24 hours of intervention

Study Arms (2)

Continuous positive airway pressure

EXPERIMENTAL

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

Procedure: Continuous positive airway pressure

Nasal Cannula

ACTIVE COMPARATOR

Blended oxygen delivered by nasal cannula (NC).

Procedure: Nasal Cannula

Interventions

Continuous positive airway pressure 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.

Also known as: CPAP

Continuous positive airway pressure

Nasal Cannula 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.

Also known as: NC

Nasal Cannula

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Hospital

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• 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.

  PMID: 38365446 DERIVED

MeSH Terms

Conditions

Disease; Hypoxia; Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Interventions

Continuous Positive Airway Pressure; Cannula

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Catheters; Equipment and Supplies

Study Officials

• Waldemar A Carlo, MD

  University of Alabama at Birmingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Neonatology Fellow

Model Details: 1:1 parallel allocation of infants to CPAP or NC oxygen using randomization with stratified permuted block design

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 10, 2021
• Study Start: August 16, 2021
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)