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NCT Number: NCT01439295

Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia

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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Key information

Conditions

Bronchopulmonary Dysplasia Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Encephalomalacia Eye Diseases Heart Defects, Congenital Heart Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Leukomalacia, Periventricular Lung Diseases Lung Injury Nervous System Diseases Respiratory Tract Diseases Retinal Diseases Retinopathy of Prematurity Vascular Diseases Ventilator-Induced Lung Injury

Age range

23 week–32 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Montreal, Sainte-Justine Hospital

Montreal, Quebec, H3T1C5, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Bronchopulmonary Dysplasia

    Time frame: 4 Months

    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

Secondary outcomes

  1. The redox status (in blood)

    Time frame: First week of life (week 1) and 36 semaines CA

    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.

  2. Major neonatal outcomes (NEC, ROP, PDA, IVH, PVL)

    Time frame: 4 Months

    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).

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2011
Registry last updated
Nov 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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