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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Lampland, Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01053455
First received: January 20, 2010
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Ventilation
Respiratory Distress Syndrome
 Device: SiPAP

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

low birth weight infants

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053455

Locations
United States, Minnesota
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
  More Information

No publications provided

Responsible Party: Andrea Lampland, Neonatologist, Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01053455     History of Changes
Other Study ID Numbers: 0911-106
Study First Received: January 20, 2010
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 23, 2013