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

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ClinicalTrials.gov Identifier: NCT01053455
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : June 22, 2012
Sponsor:
Information provided by (Responsible Party):
Andrea Lampland, Children's Hospitals and Clinics of Minnesota

Study Description
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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
Ventilation Respiratory Distress Syndrome Device: SiPAP

Study Design
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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 : January 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053455


Locations
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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
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Principal Investigator: Andrea Lampland, MD Childrens Hospitals and Clinics of MN - St. Paul
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Andrea Lampland, Neonatologist, Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01053455    
Other Study ID Numbers: 0911-106
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012
Keywords provided by Andrea Lampland, Children's Hospitals and Clinics of Minnesota:
Non-invasive ventilation
SiPAP
CPAP
low birth weight infants
respiratory distress syndrome
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases