Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function

Cynthia McEvoy

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Respiratory Distress Syndrome; Neonatal; Premature Birth

Treatments: Other: Additional 2 weeks of CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT04295564

eCPAP

Details and patient eligibility

About

This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing.

Full description

This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing. CPAP is a treatment widely used in the NICU in preterm infants right after they are born to help keep their lungs open/inflated. Although the benefit of CPAP after birth has been well studied, no one knows how long a stable preterm infant should stay on CPAP. The primary outcome of this study is to compare the lung volumes in the infants at 6 months of age by pulmonary function testing who were randomized to 2 extra weeks of CPAP in the NICU versus CPAP discontinuation, usual care. During the same pulmonary function test the investigators will also measure and compare how the infant's lungs diffuse gas.

Enrollment: 130 estimated patients

Sex: All

Ages: 1 day to 12 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Infants born at >24 to ≤ 32 weeks gestation
2. Treated with CPAP for ≥ 24 hours for respiratory distress (either as initial therapy or following extubation)

Exclusion criteria

1. Significant congenital heart disease
2. Major malformations
3. Chromosomal anomalies
4. Culture proven sepsis at consent
5. Complex maternal medical conditions
6. Clinical instability
7. Multiple gestations > twins
8. <3rd or >97th percentile for weight85
9. Participating in another neonatal randomized clinical trial with a competing outcome
10. Mother/legal guardian without stable method of communication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

eCPAP

Experimental group

Description:

Participants will remain on CPAP for 2 additional weeks once CPAP stability criteria is met.

Treatment:

Other: Additional 2 weeks of CPAP

dCPAP

No Intervention group

Description:

Participants will discontinue CPAP as per usual care once CPAP stability criteria is met.