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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Distress Syndrome Bronchopulmonary Dysplasia

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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CPAP and room air

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

Group Type ACTIVE_COMPARATOR

CPAP and room air

Intervention Type DEVICE

Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.

Room air

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CPAP and room air

Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.

Intervention Type DEVICE

Other Intervention Names

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continuous positive airway pressure

Eligibility Criteria

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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

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No