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Completed

NCT Number: NCT01053455

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

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Key information

Conditions

Ventilation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Distress Syndrome Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Childrens Hospital and Clinics of MN - St. Paul

Saint Paul, Minnesota, 55102, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • LBW infant (birth weight <2500 grams)
  • Currently on nasal CPAP
  • Use of nasal CPAP for >24 hours prior to study initiation
  • If history of intubation with mechanical ventilation, patient will be extubated >24 hours prior to study initiation
  • FiO2 requirement of 25-50%

Exclusion criteria

  • FiO2 requirement >0.5
  • Congenital defects/deformities of the head, pulmonary or cardiovascular systems
  • Chromosomal abnormalities/genetic syndromes
  • Active medical treatment for symptomatic PDA
  • Active medical treatment for culture proven sepsis
  • Within 24 hours of invasive surgical procedure

Treatment and study plan

SiPAP

Device

biphasic CPAP (SiPAP) to be alternated in 1 hour blocks with NCPAP

Sponsors and collaborators

Lead sponsor

Children's Hospitals and Clinics of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 21, 2010
Registry last updated
Jun 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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