Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
1 other identifier
interventional
14
1 country
1
Brief Summary
The purpose of this study is to test whether application of high frequency ventilation through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2006
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 22, 2006
CompletedFirst Posted
Study publicly available on registry
February 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
December 22, 2010
CompletedFebruary 9, 2018
January 1, 2018
2 years
February 22, 2006
October 29, 2010
January 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values
Capillary partial pressure of CO2 (pCO2) was measured before and after 2 hours of nasal high frequency ventilatiion in a group of subjects. Each served as his/her own control.
2 hours
Secondary Outcomes (1)
Transcutaneous CO2 Measurements as a Trend Throughout Intervention
2 hours
Study Arms (1)
Nasal High Frequency Ventilation
EXPERIMENTALStable infants born at less than 1501 g who are at least 7 days old and undergoing nasal continuous positive airway pressure treatment.
Interventions
use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong.
Eligibility Criteria
You may qualify if:
- birthweight less than 1500 g
- Age \>7 days
- Free of severe intraventricular hemorrhage (Grade III-IV)
- requiring nasal continuous positive airway pressure with a stable compensated respiratory acidosis (pH 7.25 - 7.45, pCO2 \> 43 mm Hg),
- medically stable.
You may not qualify if:
- major congenital anomalies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tarah T Colaizylead
Study Sites (1)
Children's Hospital of Iowa NICU
Iowa City, Iowa, 52242, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tarah Colaizy
- Organization
- University of Iowa
Study Officials
- PRINCIPAL INVESTIGATOR
Tarah T Colaizy, MD, MPH
University of Iowa
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
February 22, 2006
First Posted
February 24, 2006
Study Start
February 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
February 9, 2018
Results First Posted
December 22, 2010
Record last verified: 2018-01