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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01439295
Other study ID # University of Montreal
Secondary ID CIHR246505
Status Completed
Phase N/A
First received September 16, 2011
Last updated November 17, 2015
Start date August 2010
Est. completion date November 2015

Study information

Verified date November 2015
Source St. Justine's Hospital
Contact n/a
Is FDA regulated No
Health authority Canada: Canadian Institutes of Health Research
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 23 Weeks to 32 Weeks
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada University of Montreal, Sainte-Justine Hospital Montreal Quebec

Sponsors (2)

Lead Sponsor Collaborator
St. Justine's Hospital Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bronchopulmonary Dysplasia 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 4 Months No
Secondary The redox status (in blood) 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. First week of life (week 1) and 36 semaines CA No
Secondary Major neonatal outcomes (NEC, ROP, PDA, IVH, PVL) 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). 4 Months No
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