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

Children's Hospital of Philadelphia (CHOP) logo

Children's Hospital of Philadelphia (CHOP)

Status

Completed

Conditions

Infant, Premature, Diseases
Respiratory Insufficiency Syndrome of Newborn

Treatments

Device: Continuous positive airway pressure (CPAP); level changes

Study type

Interventional

Funder types

Other

Identifiers

NCT02983825
17-013910
825874 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

24 hours to 35 weeks old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

Continuous positive airway pressure (CPAP) level changes
Experimental group
Description:
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
Treatment:
Device: Continuous positive airway pressure (CPAP); level changes

Trial documents
1

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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