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

• Sponsor: Children's Hospitals and Clinics of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT01053455
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 15.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilation; Respiratory Distress Syndrome	Device: SiPAP

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: Observational Crossover Study Comparing Oxygenation and Ventilation Using Biphasic CPAP (SiPAP) Versus CPAP to Treat Respiratory Distress in Low Birth Weight Infants
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Starting on NCPAP randomized to start on NCPAP	Device: SiPAP; biphasic CPAP (SiPAP) to be alternated in 1 hour blocks with NCPAP
Starting on SiPAP randomized to SiPAP	Device: SiPAP; biphasic CPAP (SiPAP) to be alternated in 1 hour blocks with NCPAP

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Childrens Hospital and Clinics of MN - St. Paul	St. Paul	Minnesota	United States	55102

Sponsors and Collaborators

• Children's Hospitals and Clinics of Minnesota

Investigators

• Principal Investigator: Andrea Lampland, MD, Childrens Hospitals and Clinics of MN - St. Paul

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrea Lampland, Neonatologist, Children's Hospitals and Clinics of Minnesota
• ClinicalTrials.gov Identifier: NCT01053455
• Other Study ID Numbers: 0911-106
• First Posted: Jan 21, 2010
• Last Update Posted: Jun 22, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Andrea Lampland, Neonatologist, Children's Hospitals and Clinics of Minnesota: Non-invasive ventilation; SiPAP; CPAP; low birth weight infants; respiratory distress syndrome
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn

Study Results

No Results Posted as of Jun 22, 2012