Clinical Trial: Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Urinary Ascorbyl Peroxide as an Early Biological Marker of Bronchopulmonary Dysplasia in Preterm Infants Less Than 33 Weeks of Gestation

Brief Summary: 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.

Detailed Summary: 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).
Sponsor: St. Justine's Hospital

Current Primary Outcome: Bronchopulmonary Dysplasia [ Time Frame: 4 Months ]

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


Original Primary Outcome: Bronchopulmonary Dysplasia [ Time Frame: 4 Months ]

To correlate the level of urinary Ascobyl 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


Current Secondary Outcome:

  • The redox status (in blood) [ Time Frame: First week of life (week 1) and 36 semaines CA ]
    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 ]
    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).


Original Secondary Outcome:

  • The redox status (in blood) [ Time Frame: First week of life (week 1) ]
    Testing the correlation between the urinary level of ascorbyl peroxide and the redox status in the blood at 5 to 7 days of life
  • Major neonatal outcomes (NEC, ROP, PDA, IVH, PVL) [ Time Frame: 4 Months ]
    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 entercolotis (NEC), Retinopathy of prematurity (ROP),patent dusctus arteriosus(PDA), intraventricular hemorrhage (IVH) and periventricular leucomalacie (PVL).


Information By: St. Justine's Hospital

Dates:
Date Received: September 16, 2011
Date Started: August 2010
Date Completion:
Last Updated: November 17, 2015
Last Verified: November 2015