NCT00747240|Completed
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Sponsor study identifier
observational
139
1 country
2
Study Start
February 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2002
Date type not reportedThis date has not been verified as actual or estimated.
September 3, 2008
Actual (reported)September 5, 2008
Actual (reported)December 2014
Actual (reported)December 2014
Actual (reported)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)
PAF-AH genotypic and phenotypic status in relation to multiple morbidities associated with prematurity.
18 months
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.
University of Utah
Salt Lake City, Utah, 84108, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84112, United States
Christian C Yost, M.D.
University of Utah
139 participants (actual enrollment reported by the registry).
First Submitted
September 3, 2008
First Posted
September 5, 2008
Study Start
February 2002
Date type not reportedThis date has not been verified as actual or estimated.
Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
May 12, 2015
Record last verified: 2014-07
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Source: ClinicalTrials.gov.
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