Impact of CPAP Level on V/Q Mismatch in Premature Infants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2020-02-13

Brief Summary

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Continuous positive airway pressure (CPAP) is used in premature infants to maintain lungs open and facilitate gas exchange. When ventilation/perfusion (V/Q) mismatch is present, areas of the lung that are open for gas exchange do not match up with the areas of the lung that are receiving blood for gas exchange. This study measure the responsiveness of V/Q mismatch to changes in the amount (or level) of CPAP.

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Detailed Description

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Conditions

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Infant, Premature, Diseases Respiratory Insufficiency Syndrome of Newborn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous positive airway pressure (CPAP) level changes

Protocol guided changes in CPAP level from clinical baseline, with responsiveness in V/Q mismatch guiding subsequent changes; limited to a range of -2 to +3 cm H2O from baseline

Group Type EXPERIMENTAL

Continuous positive airway pressure (CPAP); level changes

Intervention Type DEVICE

as per arm description

Interventions

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Continuous positive airway pressure (CPAP); level changes

as per arm description

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Born at 27-35 weeks gestational age (GA) by best obstetric estimate, determined by the clinical obstetric team during antepartum admission.
2. Age limits: 24 hours of age - 35 weeks corrected gestational age.
3. On continuous CPAP support between 4-8 cm H2O for greater than 24 hours, as document on the bedside infant flow sheet.
4. Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) 0.25 for at least 2 consecutive hours, as documented on the bedside infant flow sheet.

Exclusion Criteria

1. Congenital anomalies, as determined by the clinical supervising physician.
2. Current or prior air leak syndrome, as determined by the clinical supervising physician.

Minimum Eligible Age

24 Hours

Maximum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No