Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia

This study is currently recruiting participants.
Verified November 2013 by St. Justine's Hospital
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: November 12, 2013
Last verified: November 2013
  Purpose

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
Bronchopulmonary Dysplasia

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 240
Study Start Date: August 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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).

  Eligibility

Ages Eligible for Study:   23 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Preterm infants less than 33 weeks of getation

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439295

Contacts
Contact: Ibrahim Mohamed, MB CHB 15143454931 ext 4441 ibrahim.mohamed@umontreal.ca
Contact: Jean-Claude Lavoie, PhD 15143454931 ext 3940 jean-claude.lavoie@umontreal.ca

Locations
Canada, Quebec
University of Montreal, Sainte-Justine Hospital Recruiting
Montreal, Quebec, Canada, H3T1C5
Contact: Ibrahim Mohamed, MB ChB    15143454931 ext 4441    ibrahim.mohamed@umontreal.ca   
Principal Investigator: Ibrahim Mohamed, MB ChB         
Principal Investigator: Jean-Claude Lavoie, PhD         
Sub-Investigator: Anne-Monique Nuyt, MD         
Sponsors and Collaborators
St. Justine's Hospital
Canadian Institutes of Health Research (CIHR)
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Ibrahim Mohamed, Adjunct professor of peditarics, division of neonatology, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01439295     History of Changes
Other Study ID Numbers: University of Montreal, CIHR246505
Study First Received: September 16, 2011
Last Updated: November 12, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by 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
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on April 17, 2014