Continued Pressure for Alveolar Protection (CPAP Trial)

N/ANot Yet RecruitingNCT07417111

NICHD Neonatal Research Network860 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

860

Conditions

Bronchopulmonary Dysplasia (BPD)

Interventions

CPAPDEVICE

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.

Nasal CannulaDEVICE

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.

Eligibility

Sex: ALLMax age: 31 Weeks

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bronchopulmonary Dysplasia or Death

The likelihood of BPD or death at 36 weeks' Postmenstrual Age (PMA): a five-level ordinal outcome (death, survival with grade 3 BPD, survival with grade 2 BPD, survival with grade 1 BPD, and survival free of any BPD).

Time frame: 36 Weeks' PMA

Secondary Outcomes

Days alive and off respiratory support

The number of days alive and off respiratory support from 34 weeks' to 40 weeks' PMA

Time frame: 34-40 weeks' PMA

Mortality at 36 Weeks

Mortality

Time frame: 36 Weeks' PMA

Death or Grade 2-3 BPD

Mortality at 36 weeks' PMA or grade 3 BPD

Time frame: 36 Weeks' PMA

Death or Grade 3 BPD

Mortality or grade 3 BPD

Time frame: 36 Weeks' PMA

Retinopathy of prematurity

Retinopathy of prematurity ≥ stage 3 or requiring treatment (laser/anti-VEGF)

Time frame: 52 weeks' PMA

Respiratory support, supplemental oxygen, and pulmonary medications

Use of supplemental oxygen, respiratory support (including low-flow nasal cannula), and pulmonary medications (methylxanthines, steroids, diuretics, albuterol) at discharge and 40 weeks' PMA

Time frame: 40 weeks' PMA

Full PO feedings

PMA at first full PO feeding (where full PO feeding is defined as intake of 120 mL/kg/day by mouth, even if an NG tube remains in situ)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.