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

June 21, 2012 updated by: Andrea Lampland, Children's Hospitals and Clinics of Minnesota

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • St. Paul, Minnesota, United States, 55102
        • Childrens Hospital and Clinics of MN - St. Paul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

low birth weight infants

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospitals and Clinics of Minnesota

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

January 20, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (ESTIMATE)

January 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0911-106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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