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

Children's Hospitals and Clinics of Minnesota

Status: Completed

Conditions: Ventilation; Respiratory Distress Syndrome

Treatments: Device: SiPAP

Study type: Observational

Funder types: Other

Identifiers

NCT01053455

0911-106

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Starting on NCPAP

Description:

randomized to start on NCPAP

Treatment:

Device: SiPAP

Starting on SiPAP

Description:

randomized to SiPAP

Treatment:

Device: SiPAP