Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia
This study is not yet open for participant recruitment.
Verified September 2011 by St. Justine's Hospital
Sponsor:
St. Justine's Hospital
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: September 22, 2011
Last verified: September 2011
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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 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
Secondary Outcome Measures:
- 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).
Biospecimen Retention: Samples With DNA
Urine sample (650 µl) Blood sample (500 µl)
| Estimated Enrollment: | 240 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | November 2013 (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.
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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 | Not yet 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: | September 22, 2011 |
| 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 Hyperplasia Ventilator-Induced Lung Injury Lung Injury Lung Diseases |
Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013