Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia

NCT01439295 | Completed

• 2 other identifiers: University of MontrealCIHR246505
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia

Keywords

Ascorbyl peroxide; Bronchopulmonary dysplasia; Redox status; Necrotising entercolitis; Retinopathy of prematurity; Patent ductus arteriosus; Intraventricular hemorrhage; Periventricular leucomalacia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• The redox status (in blood)

  First week of life (week 1) and 36 semaines CA

• Major neonatal outcomes (NEC, ROP, PDA, IVH, PVL)

  4 Months

Study Arms (1)

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.

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants less than 33 weeks of getation

You may qualify if:

• 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

You may not qualify if:

• Major congenital anomalies
• Sever perinatal asphyxia

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Montreal, Sainte-Justine Hospital

Montreal, Quebec, H3T1C5, Canada

Location

Related Links

• 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
• Admixture of a Multivitamin Preparation to Parenteral Nutrition: The Major Contributor to In Vitro Generation of Peroxides
• Paradoxical Role of Ascorbic Acid and Riboflavin in Solutions of Total Parenteral Nutrition: Implication in Photoinduced Peroxide Generation

Biospecimen

Retention: SAMPLES WITH DNA

Urine sample (650 µl) Blood sample (500 µl)

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Retinopathy of Prematurity; Ductus Arteriosus, Patent; Leukomalacia, Periventricular

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Retinal Diseases; Eye Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalomalacia; Vascular Diseases

Study Officials

• Ibrahim Mohamed, Mb CHB

  University of Montreal, Sainte Justine Hospital

  PRINCIPAL INVESTIGATOR

• Jean-claude Lavoie, PhD

  University of Montreal, Sainte-Justine hospital research center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor of peditarics, division of neonatology

Study Record Dates

• First Submitted: September 16, 2011
• First Posted: September 23, 2011
• Study Start: August 1, 2010
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

CA (1)