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Purpose

The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at 36 weeks' PMA.

Condition

Eligibility

Eligible Ages
Under 31 Weeks
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Gestational age <29 weeks at birth - PMA <32 weeks at study entry - On treatment with CPAP without a rate in FiO2 <0.25 and PEEP of 4-5 cmH2O - Meet stability criteria: - 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 - No episodes of apnea or bradycardia requiring intervention (oxygen/stimulation/bag and mask) for 24 hours - Parents/legal guardians consent for enrollment

Exclusion Criteria

  • Major malformation - Neuromuscular condition that affects respiration - Terminal illness - Decision to withhold or limit support - Too sick to participate in opinion of Attending physician - Clinical shock, sepsis - Planned surgery during study period

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This will be a randomized controlled trial with a 1:1 parallel allocation of infants to Continuous Positive Airway Pressure (CPAP) or Nasal Cannula (NC) using stratified permuted block design. Randomization will be stratified by gestational age (≥ 22 0/7 weeks to ≤ 24 6/7 weeks, ≥ 25 0/7 weeks to ≤ 26 6/7, and ≥ 27 0/7 to ≤ 28 6/7).
Primary Purpose
Prevention
Masking
None (Open Label)
Masking Description
The inherent nature of ventilator/respiratory support interventions often precludes the ability to blind investigators and caregivers. As such, many studies in this domain face the limitation of not being blinded. The study team recognizes this limitation and will implement measures to mitigate potential biases arising from an unblinded trial. The DCC PI who will be overseeing the statistical team will be masked. Additionally, interim analysis (efficacy and safety) reports presented to the Data and Safety Monitoring Board (DSMB) will be masked.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Continuous Positive Airway Pressure 		CPAP will be provided via mask or binasal prongs to maintain a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery whenever available.
  • Device: CPAP
    Prior to study entry, the CPAP interface (includes RAM cannula, Optiflow, large bore cannulas, mask, prongs) and mode (bubble, variable-flow, ventilator-derived) used is at the discretion of the provider and center. After study entry, CPAP will be provided via mask or binasal prongs to maintain a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery whenever available.
Active Comparator
Nasal Cannula 		HFNC at 4 L/min will be used initially in the control group. Flow should be titrated down by 1 L/min per day until ≤0.5 L/kg among infants in the nasal cannula group if not meeting pre-specified failure criteria to reduce the risk of inadvertent positive end-expiratory pressure (PEEP). Flow can also be increased (up to 6 L/min maximum) if needed among infants on NC who meet the pre-specified failure criteria. Infants in the control group placed back on CPAP may use an interface at provider discretion.
  • Device: Nasal Cannula
    HFNC at 4 L/min will be used initially in the control group. Flow should be titrated down by 1 L/min per day until ≤0.5 L/kg among infants in the nasal cannula group if not meeting pre-specified failure criteria to reduce the risk of inadvertent positive end-expiratory pressure (PEEP). Flow can also be increased (up to 6 L/min maximum) if needed among infants on NC who meet the pre-specified failure criteria. Infants in the control group placed back on CPAP may use an interface at provider discretion.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Waldemar A Carlo, MD

Stanford University
Palo Alto, California 94304
Contact:
Valerie Chock, MD

Sharp Mary Birch Hospital for Women & Newborns
San Diego, California 92123
Contact:
Anup Katheria, MD

Emory University
Atlanta, Georgia 30303
Contact:
Ravi Patel, MD

Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
Contact:
Aaron Hamvas, MD

University of Iowa
Iowa City, Iowa 52242
Contact:
Tarah Colaizy, MD

University of Mississippi Medical Center - Children's of Mississippi
Jackson, Mississippi 39216
Contact:
Abhay Bhatt, MD

University of New Mexico
Albuquerque, New Mexico 87131
Contact:
Janell Fuller, MD

Duke University
Durham, North Carolina 27710
Contact:
Michael Cotton, MD

Cincinnati Children's Medical Center
Cincinnati, Ohio 45267
Contact:
Stephanie Merhar, MD MS

Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio 44106
Contact:
Anna M Hibbs, MD

University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Sara DeMauro, MD

University of Texas Southwestern Medical Center at Dallas
Dallas, Texas 75235
Contact:
Myra Wyckoff, MD

University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Matthew Rysavy, MD

University of Utah
Salt Lake City, Utah 84108
Contact:
Robin Ohls, MD

More Details

Status
Recruiting
Sponsor
NICHD Neonatal Research Network

Study Contact

Colm P. Travers, MD
205-934-3100
cptravers@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.