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

Observational Crossover Study Comparing Oxygenation and Ventilation Using Biphasic CPAP (SiPAP) Versus CPAP to Treat Respiratory Distress in Low Birth Weight Infants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01053455
Enrollment
20
Registered
2010-01-21
Start date
2010-01-31
Completion date
2011-05-31
Last updated
2012-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Ventilation

Keywords

Non-invasive ventilation, SiPAP, CPAP, low birth weight infants, respiratory distress syndrome

Brief summary

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.

Interventions

DEVICESiPAP

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

Sponsors

Children's Hospitals and Clinics of Minnesota
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026