Observational Crossover Study Comparing Oxygenation and Ventilation Using SiPAP Versus CPAP in LBW Infants

Children's Hospitals and Clinics of Minnesota20 enrolled

Overview

Investigation of effects of SiPAP versus NCPAP on oxygenation and ventilation in LBW infants with respiratory distress. Our hypothesis is that the LBW infants will achieve the same level of oxygenation and improved ventilation when being treated with SiPAP as compared to NCPAP.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ventilation Respiratory Distress Syndrome

Interventions

SiPAPDEVICE

biphasic CPAP (SiPAP) to be alternated in 1 hour blocks with NCPAP

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. LBW infant (birth weight \<2500 grams) 2. Currently on nasal CPAP 3. Use of nasal CPAP for \>24 hours prior to study initiation 4. If history of intubation with mechanical ventilation, patient will be extubated \>24 hours prior to study initiation 5. FiO2 requirement of 25-50% Exclusion Criteria: 1. FiO2 requirement \>0.5 2. Congenital defects/deformities of the head, pulmonary or cardiovascular systems 3. Chromosomal abnormalities/genetic syndromes 4. Active medical treatment for symptomatic PDA 5. Active medical treatment for culture proven sepsis 6. Within 24 hours of invasive surgical procedure

Locations (1)

Childrens Hospital and Clinics of MN - St. Paul

Saint Paul, Minnesota, United States

Data from ClinicalTrials.gov

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