Continued Pressure for Alveolar Protection (CPAP Trial)
ConditionBronchopulmonary Dysplasia (BPD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 31
SponsorNICHD Neonatal Research Network
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
If previously intubated must be extubated ≥ 72 hours
Disqualifiers
Major malformation
Neuromuscular condition that affects respiration
Terminal illness
Decision to withhold or limit support
Trial design
Design model
Parallel
Treatments tested in this trial
CPAP
DevicePrior 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 Cannula
DeviceHFNC 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.
Treatment groups
860 Participants
are divided into 2 treatment groupsGroup A: Continuous Positive Airway PressureExperimental treatment 1 intervention
Group B: Nasal CannulaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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' PMASecondary outcomes
1
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' PMA2
Mortality at 36 Weeks
Mortality
Time frame
36 Weeks' PMA3
Death or Grade 2-3 BPD
Mortality at 36 weeks' PMA or grade 3 BPD
Time frame
36 Weeks' PMA4
Death or Grade 3 BPD
Mortality or grade 3 BPD
Time frame
36 Weeks' PMAOther outcomes
1
Post-prematurity respiratory disease at two years follow up
Post-prematurity respiratory disease (PPRD) or death at 22-26 months follow-up.
Time frame
22-26 months2
Pulmonary medications and respiratory support at two years follow up
Pulmonary medications (inhaled or oral steroids, bronchodilators, diuretics, and vasodilators), history of rehospitalizations for respiratory reasons, pulmonary clinic visits, respiratory support (including oxygen, CPAP, or ventilation), bronchoscopy, and respiratory-related surgeries such as tracheal surgeries, repairs, and dilatations; and wheezing or diagnosis of asthma using a modified ISAAC questionnaire at 22-26 months follow-up.
Time frame
22-26 months3
Long-term mortality
Mortality at 22-28 month follow up
Time frame
22-26 months4
Nasal/skin injury
Presence of nasal/skin injury during study intervention period
Time frame
36 Weeks' PMASponsors and contacts
Click on the lead sponsor to view all of their trials.
NICHD Neonatal Research Network
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov