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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2024-03-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neonatal Premature Birth Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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eCPAP

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

Group Type EXPERIMENTAL

Additional 2 weeks of CPAP

Intervention Type OTHER

Subjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care.

dCPAP

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Additional 2 weeks of CPAP

Subjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No