Continued Pressure for Alveolar Protection (CPAP Trial)

Official title

Continued Pressure for Alveolar Protection: A Randomized Controlled Trial (CPAP Trial)

Overview

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.

Interventions

• 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.
• 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 discr

Primary outcome measures

• Bronchopulmonary Dysplasia or Death [Time frame: 36 Weeks' PMA]

Secondary outcome measures (8)

• Days alive and off respiratory support [Time frame: 34-40 weeks' PMA]
• Mortality at 36 Weeks [Time frame: 36 Weeks' PMA]
• Death or Grade 2-3 BPD [Time frame: 36 Weeks' PMA]
• Death or Grade 3 BPD [Time frame: 36 Weeks' PMA]
• Retinopathy of prematurity [Time frame: 52 weeks' PMA]
• Respiratory support, supplemental oxygen, and pulmonary medications [Time frame: 40 weeks' PMA]
• Full PO feedings [Time frame: 52 weeks' PMA]
• Length of hospitalization [Time frame: 52 Weeks' PMA]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 15 centers

• University of Alabama at Birmingham — Birmingham
• Stanford University — Palo Alto
• Sharp Mary Birch Hospital for Women & Newborns — San Diego
• Emory University — Atlanta
• Northwestern Lurie Children's Hospital of Chicago — Chicago
• University of Iowa — Iowa City
• University of Mississippi Medical Center - Children's of Mississippi — Jackson
• University of New Mexico — Albuquerque
• … and 7 more centers

Identifiers

NCT: NCT07417111 · NICHD-NRN-0067 · 1U01HD115553-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗