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NCT01053455 Clinical Trial

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

Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01053455
Other study ID # 0911-106
Secondary ID
Status Completed
Phase N/A
First received January 20, 2010
Last updated June 21, 2012
Start date January 2010
Est. completion date May 2011

Study information
Verified date June 2012
Source Children's Hospitals and Clinics of Minnesota
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Childrens Hospital and Clinics of MN - St. Paul St. Paul Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

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