Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Treatments: Device: CPAP and room air

Study type: Interventional

Funder types: Other

Identifiers

NCT02249143

eIRB00010607

Details and patient eligibility

About

The primary aim of this study is to quantify and compare changes in lung volumes (as measured by functional residual capacity) in premature infants stable on continuous positive airway pressure (CPAP), and then randomized to two additional weeks of CPAP and room air versus room air alone. We hypothesize that infants randomized to additional CPAP will demonstrate an increased functional residual capacity (at the end of the two week study period and prior to discharge) compared to those randomized to room air.

Enrollment: 50 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age at birth <33 weeks
• Required CPAP for a minimum of 24 hours for respiratory distress
• Patient on CPAP and room air at time of randomization

Exclusion criteria

• Complex congenital heart disease other than patent ductus arteriosus or atrial septal defect
• Major malformations or chromosomal anomalies
• Multiple gestation greater than twins
• Culture proven sepsis or unstable at time of randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

CPAP and room air

Active Comparator group

Description:

Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.

Treatment:

Device: CPAP and room air

Room air

No Intervention group

Description:

Premature stable infants on CPAP and room air will be randomized to transition to room air alone.