Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia

Study Overview
=================
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).

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

Conditions
-----------------
Bronchopulmonary Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 23 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm less than 33 weeks<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ascorbyl peroxide, Bronchopulmonary dysplasia, Redox status, Necrotising entercolitis, Retinopathy of prematurity, Patent ductus arteriosus, Intraventricular hemorrhage, Periventricular leucomalacia