Study Stopped
Lack of enrollment
Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates
2 other identifiers
interventional
8
1 country
1
Brief Summary
The purpose of this study is to determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 18, 2014
CompletedFirst Posted
Study publicly available on registry
June 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedJuly 21, 2017
July 1, 2017
2.7 years
June 18, 2014
July 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Oxygenation
Pulse oximetry
3 hrs
Ventilation
transcutaneous carbon dioxide monitor
3 hrs
Secondary Outcomes (2)
Esophageal pressure measurements
3 hrs
Apnea
3 hrs
Other Outcomes (4)
Pulse
3 hrs
Respiratory Rate
3 hrs
Blood Pressure
3 hrs
- +1 more other outcomes
Study Arms (2)
RAM Cannula CPAP
EXPERIMENTALCPAP provided by RAM Cannula
Binasal Prong CPAP
ACTIVE COMPARATORCPAP provided by binasal prong
Interventions
Eligibility Criteria
You may qualify if:
- Low Birth Weight Infant
- Currently on continuous positive aireway pressure of 5-7 cm water pressure
- Receiving continuous positive airway pressure support for \> 24 hrs prior to enrollment
- Fraction of inspired oxygen requirement of 23-50%
You may not qualify if:
- Fraction of inspired oxygen \> 50%
- Congenital defects of head, pulmonary or cardiovascular systems
- Chromosomal abnormalities/genetic syndromes
- Invasive Surgical Procedure within 24 hrs prior to enrollment
- Enrollment in separate clinical trial that has ongoing data collection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55102, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neil P Mulrooney, MD
Children's Hospitals and Clinics of Minnesota
- PRINCIPAL INVESTIGATOR
Andrea L Lampland, MD
Children's Hospitals and Clinics of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2014
First Posted
June 20, 2014
Study Start
June 1, 2014
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
July 21, 2017
Record last verified: 2017-07