Platelet-activating Factor Acetylhydrolase (Paf-ah) Gene Expression
1 other identifier
observational
139
1 country
2
Brief Summary
This is a prospective observational study to determine whether there is an association between the presence of platelet-activating factor acetylhydrolase (PAF-AH) gene polymorphisms and the development of chronic lung disease in very low birth wight infants. Infants \< 1500 grams at birth who require mechanical ventilation will be enrolled in the first 5 days of life after obtaining informed consent. A total of 1 ml of blood will be drawn and utilized for isolation of DNA for genotyping and for measurement of PAF-AH activity in serum.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2002
Longer than P75 for all trials
2 active sites
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, 2002
CompletedFirst Submitted
Initial submission to the registry
September 3, 2008
CompletedFirst Posted
Study publicly available on registry
September 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 12, 2015
July 1, 2014
12.8 years
September 3, 2008
May 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Chronic Lung Disease (CLD) and survival at 36 weeks corrected gestational age (CGA).
CLD will be defined as an oxygen requirement and abnormal x-ray findings. Investigations will compare outcomes of participants with genotypic variants of PAF-AH and those without known PAF-AH polymorphisms. Also, participant with biochemical evidence of PAF-AH dysregulation will be compared to those with normal PAF-AH protein and PAF concentrations.
at 36 weeks (CGA)
Secondary Outcomes (1)
PAF-AH genotypic and phenotypic status in relation to multiple morbidities associated with prematurity.
18 months
Eligibility Criteria
Eligible Patients Patients hospitalized in the NICU who: 1. weigh ≤ 1500 grams at birth, 2. are enrolled at age ≤ 5 days, 3. require mechanical ventilation or continuous positive airway pressure (CPAP), 4. have parents or guardians that have signed the informed consent document. Excluded Patients Infants with major congenital anomalies will be excluded.
You may qualify if:
- Patients hospitalized in the NICU who:
- weigh ≤ 1500 grams at birth,
- are enrolled at age ≤ 5 days,
- require mechanical ventilation or continuous positive airway pressure (CPAP),
- have parents or guardians that have signed the informed consent document.
You may not qualify if:
- Infants with major congenital anomalies will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Utah
Salt Lake City, Utah, 84108, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84112, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Christian C Yost, M.D.
University of Utah
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 3, 2008
First Posted
September 5, 2008
Study Start
February 1, 2002
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
May 12, 2015
Record last verified: 2014-07