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
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 16, 2011 | ||||||||
| Last Updated Date | September 22, 2011 | ||||||||
| Start Date ICMJE | November 2011 | ||||||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01439295 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia | ||||||||
| Official Title ICMJE | 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. |
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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). |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Urine sample (650 µl) Blood sample (500 µl) |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Preterm infants less than 33 weeks of getation |
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| Condition ICMJE | Bronchopulmonary Dysplasia | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | 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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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 240 | ||||||||
| Estimated Completion Date | June 2014 | ||||||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 23 Weeks to 32 Weeks | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01439295 | ||||||||
| Other Study ID Numbers ICMJE | University of Montreal, CIHR246505 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Ibrahim Mohamed, St. Justine's Hospital | ||||||||
| Study Sponsor ICMJE | St. Justine's Hospital | ||||||||
| Collaborators ICMJE | Canadian Institutes of Health Research (CIHR) | ||||||||
| Investigators ICMJE |
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| Information Provided By | St. Justine's Hospital | ||||||||
| Verification Date | September 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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