Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01439295

Enrollment

Registered

2011-09-23

Start date

2010-08-31

Completion date

2015-11-30

Last updated

2015-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia

Keywords

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

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.

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

23 Weeks to 32 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Bronchopulmonary Dysplasia	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

Measure	Time frame	Description
The redox status (in blood)	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.
Major neonatal outcomes (NEC, ROP, PDA, IVH, PVL)	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).

Countries

Canada

Outcome results