Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04792099
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : August 23, 2021
Sponsor:
Information provided by (Responsible Party):
Siamak Yazdi, University of Alabama at Birmingham

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Infant, Newborn, Disease Hypoxia Respiratory Distress Syndrome Bronchopulmonary Dysplasia Procedure: Continuous positive airway pressure Procedure: Nasal Cannula Not Applicable

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 three randomization strata [≥ 22+0/7 to ≤ 25+6/7 weeks, ≥ 26+0/7 to ≤ 29+6/7 weeks, and ≥ 30+0/7 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..

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 parallel allocation of infants to CPAP or NC oxygen using randomization with stratified permuted block design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CPAP Or Nasal Cannula Oxygen for Preterm Infants: A Randomized Controlled Trial
Actual Study Start Date : August 16, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Continuous positive airway pressure
Continuous positive airway pressure (CPAP) with blended oxygen delivered by binasal prongs or nasal mask.
 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.
Other Name: CPAP
Active Comparator: Nasal Cannula
Blended oxygen delivered by nasal cannula (NC).
 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.
Other Name: NC


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The number of episodes with oxygen saturations less than 85% for ≥ 10 seconds [ Time Frame: 24 hours of intervention ]

Secondary Outcome Measures :
  1. The coefficient of variability of oxygen saturations (relative standard deviation) [ Time Frame: 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.

  2. The proportion of time with oxygen saturations > 95 % among infants requiring supplemental oxygen [ Time Frame: 24 hours of intervention ]
  3. The proportion of time spent outside oxygen saturation target ranges (91-95%) among infants requiring supplemental oxygen [ Time Frame: 24 hours of intervention ]
  4. The proportion of time with oxygen saturations less than 85% [ Time Frame: 24 hours of intervention ]
  5. The median supplemental oxygen concentration [ Time Frame: 24 hours of intervention ]
  6. The median transcutaneous carbon dioxide value [ Time Frame: 24 hours of intervention ]
  7. The number of episodes (≥ 10 seconds) with oxygen saturations less than 80 % [ Time Frame: 24 hours of intervention ]
  8. The number of recorded episodes (≥ 10 seconds) of bradycardia < 100/min [ Time Frame: 24 hours of intervention ]
  9. The median cNIRS value [ Time Frame: 24 hours of intervention ]
    Median cerebral near-infrared spectroscopy value during the 24 hour intervention period

  10. The median aNIRS value [ Time Frame: 24 hours of intervention ]
    Median abdominal near-infrared spectroscopy value during the 24 hour intervention period


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04792099


Contacts
Layout table for location contacts
Contact: Zaki (Siamak) Yazdi, MD (205) 934-4793 syazdi@uabmc.edu

Locations
Layout table for location information
United States, Alabama
UAB Hospital Recruiting
Birmingham, Alabama, United States, 35233
Contact: Zaki Yazdi, MD    205-934-4680    syazdi@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Layout table for investigator information
Study Director: Waldemar A Carlo, MD University of Alabama at Birmingham
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Siamak Yazdi, Principal Investigator, Neonatology Fellow, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04792099    
Other Study ID Numbers: UAB Neo ZY 2021
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Bronchopulmonary Dysplasia
Infant, Newborn, Diseases
Hypoxia
Lung Diseases
 Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Signs and Symptoms, Respiratory
Ventilator-Induced Lung Injury
Lung Injury