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Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ibrahim Mohamed, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01439295
First received: September 16, 2011
Last updated: July 10, 2014
Last verified: July 2014

September 16, 2011
July 10, 2014
August 2010
December 2014   (final data collection date for primary outcome measure)
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
Bronchopulmonary Dysplasia [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01439295 on ClinicalTrials.gov Archive Site
  • 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).
  • The redox status (in blood) [ Time Frame: First week of life (week 1) ] [ 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
  • 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 entercolotis (NEC), Retinopathy of prematurity (ROP),patent dusctus arteriosus(PDA), intraventricular hemorrhage (IVH) and periventricular leucomalacie (PVL).
Not Provided
Not Provided
 
Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia
Urinary Ascorbyl Peroxide as an Early Biological Marker of Bronchopulmonary Dysplasia in Preterm Infants Less Than 33 Weeks of Gestation

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Urine sample (650 µl) Blood sample (500 µl)

Non-Probability Sample

Preterm infants less than 33 weeks of getation

Bronchopulmonary Dysplasia
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
June 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Preterm infants less than 33 weeks of gestation<
  • Admission to CHU Sainte-JUstien neonatal intensive care unit
  • Receiving Parenteral nutrition during the first week of life
  • Parental consent

Exclusion Criteria:

  • Major congenital anomalies
  • Sever perinatal asphyxia
Both
23 Weeks to 32 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01439295
University of Montreal, CIHR246505
No
Ibrahim Mohamed, St. Justine's Hospital
St. Justine's Hospital
Canadian Institutes of Health Research (CIHR)
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
St. Justine's Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP