Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Urinary Ascorbyl Peroxide as an Early Biological Marker of Bronchopulmonary Dysplasia in Preterm Infants Less Than 33 Weeks of Gestation

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

• Bronchopulmonary Dysplasia

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

External Links

•   Association between Hydrogen Peroxide-Dependent Byproducts of Ascorbic Acid and Increased Hepatic Acetyl-CoA Carboxylase Activity
•   Light-Induced Byproducts of Vitamin C in Multivitamin Solutions
•   Neonatal Exposure to Oxidants Induces Later in Life a Metabolic Response Associated to a Phenotype of Energy Deficiency in an Animal Model of Total Parenteral Nutrition
•   Paradoxical Role of Ascorbic Acid and Riboflavin in Solutions of Total Parenteral Nutrition: Implication in Photoinduced Peroxide Generation