Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01439295
Recruitment Status : Completed
First Posted : September 23, 2011
Last Update Posted : November 18, 2015
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ibrahim Mohamed, St. Justine's Hospital

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.

Condition or disease
Bronchopulmonary Dysplasia

Detailed Description:
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).

Study Type : Observational
Actual Enrollment : 51 participants
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
Study Start Date : August 2010
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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).

Biospecimen Retention:   Samples With DNA
Urine sample (650 µl) Blood sample (500 µl)

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Ages Eligible for Study:   23 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants less than 33 weeks of getation

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01439295

Canada, Quebec
University of Montreal, Sainte-Justine Hospital
Montreal, Quebec, Canada, H3T1C5
Sponsors and Collaborators
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

Additional Information:
Responsible Party: Ibrahim Mohamed, Adjunct professor of peditarics, division of neonatology, St. Justine's Hospital Identifier: NCT01439295     History of Changes
Other Study ID Numbers: University of Montreal
CIHR246505 ( Other Grant/Funding Number: Canadain Institute of Health Research (CIHR) )
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by Ibrahim Mohamed, St. Justine's Hospital:
Ascorbyl peroxide
Bronchopulmonary dysplasia
Redox status
Necrotising entercolitis
Retinopathy of prematurity
Patent ductus arteriosus
Intraventricular hemorrhage
Periventricular leucomalacia

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Pathologic Processes
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases