An interventional study of CPAP and Nasal Cannula in Bronchopulmonary Dysplasia (BPD), sponsored by NICHD Neonatal Research Network. Recruiting at 15 sites in United States. Open to participants aged Up to 31 Weeks. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by NICHD Neonatal Research Network · Not applicable, Interventional, and Prevention
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.
362 studies on the registry are indexed under Bronchopulmonary Dysplasia; 85 are open to participants now.
This study's planned enrollment of 860 is above the median of 66 across 244 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →NICHD Neonatal Research Network is the lead sponsor of 63 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
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.
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
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)
Time frame: 52 weeks' PMA
Length of hospitalization
Length of hospitalization from 34 weeks' PMA
Time frame: 52 Weeks' PMA
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 months
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 months
Long-term mortality
Mortality at 22-28 month follow up
Time frame: 22-26 months
Nasal/skin injury
Presence of nasal/skin injury during study intervention period
Time frame: 36 Weeks' PMA
Nebulized epinephrine to treat Stridor
Nebulized epinephrine for stridor during intervention period
Time frame: 36 Weeks' PMA
Tracheomalacia
Tracheomalacia diagnosed by bronchoscopy before discharge
Time frame: 52 Weeks' PMA
Intubation, chest compressions/epinephrine
Intubation and/or chest compressions/epinephrine during study intervention period
Time frame: 36 Weeks' PMA
Pneumothorax
Pneumothorax during study intervention period
Time frame: 36 Weeks' PMA
Plan to share: Yes — NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov).
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
Of 71 non-industry interventional studies with no phase under Bronchopulmonary Dysplasia, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 56. This study's planned 24 months is below that.
Counting every sponsor, half of 73 studies reached it within 37 months; a quarter within 19 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
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NICHD Neonatal Research Network