Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia
Urinary ascorbyl peroxide level in the first week of life will be a good predictor of Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Urinary Ascorbyl Peroxide as an Early Biological Marker of Bronchopulmonary Dysplasia in Preterm Infants Less Than 33 Weeks of Gestation|
- Bronchopulmonary Dysplasia [ Time Frame: 4 Months ] [ Designated as safety issue: No ]To correlate the level of urinary Ascorbyl peroxide and BPD. Full diagnosis and classification (to mild, moderate or severe) is at 36 weeks of corrected age; so even for most premature infants (like 23 weeks of gestation) there will be a need for follow up for less than 4 month to have the final diagnosis at 36 weeks
- The redox status (in blood) [ Time Frame: First week of life (week 1) and 36 semaines CA ] [ Designated as safety issue: No ]Testing the correlation between the urinary level of ascorbyl peroxide and the redox status in the blood at 5 to 7 days of life. Measuring the Redox potential at 36 weeks corrected age to investigate long term effect of early oxidative stress.
- Major neonatal outcomes (NEC, ROP, PDA, IVH, PVL) [ Time Frame: 4 Months ] [ Designated as safety issue: No ]These outcomes are the major neonatal outcomes for preterm infants, we would test the correlation between ascorbyl peroxide (as marker of oxidative stress) and like Necrotising enterocolotis (NEC), Retinopathy of prematurity (ROP),patent ductus arteriosis(PDA), intraventricular hemorrhage (IVH) and periventricular leucomalacia (PVL).
Biospecimen Retention: Samples With DNA
Urine sample (650 µl) Blood sample (500 µl)
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Preterm less than 33 weeks
This cohort will be composed of premature infants born before 33 weeks of gestational age, admitted to the neonatal intensive care unit at Sainte-Justine hospital and receiving parenteral nutrition (PN) during their first week of life.
This study uses ascorbyl peroxide as representative of oxidative stress in premature infants on parenteral nutrition and aims to test the correlation of this metabolite and the different major neonatal outcomes 'mainly bronchopulmonary dysplasia).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439295
|University of Montreal, Sainte-Justine Hospital|
|Montreal, Quebec, Canada, H3T1C5|
|Principal Investigator:||Ibrahim Mohamed, Mb CHB||University of Montreal, Sainte Justine Hospital|
|Study Director:||Jean-claude Lavoie, PhD||University of Montreal, Sainte-Justine hospital research center|