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

Completed

• Conditions: Ventilation; Respiratory Distress Syndrome
• Interventions: Device: SiPAP

• Registration Number: NCT01053455
• Lead Sponsor: Children's Hospitals and Clinics of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Starting on NCPAP	SiPAP	randomized to start on NCPAP
Starting on SiPAP	SiPAP	randomized to SiPAP

Trial Locations

Locations (1)

Childrens Hospital and Clinics of MN - St. Paul; 🇺🇸 St. Paul, Minnesota, United States