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

Completed

Conditions studied: Ventilation, Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT01053455

Run by

Children's Hospitals and Clinics of Minnesota

People needed

20

Starts

2010-01-01

Expected to finish

2011-05-01

Last updated by the study team

2012-06-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• LBW infant (birth weight <2500 grams)
• Currently on nasal CPAP
• Use of nasal CPAP for >24 hours prior to study initiation
• If history of intubation with mechanical ventilation, patient will be extubated >24 hours prior to study initiation
• FiO2 requirement of 25-50%

You may not qualify if…

• FiO2 requirement >0.5
• Congenital defects/deformities of the head, pulmonary or cardiovascular systems
• Chromosomal abnormalities/genetic syndromes
• Active medical treatment for symptomatic PDA
• Active medical treatment for culture proven sepsis
• Within 24 hours of invasive surgical procedure

Where it is running

• Childrens Hospital and Clinics of MN - St. Paul — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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