Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328419
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2006-05-19
Brief Title:
Consequences of Parenteral Nutrition Photoprotection on Oxidant Related Diseases Among Extremely Low Birth Weight Infants
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Consequences of Parenteral Nutrition Photoprotection on the Oxidant Related Diseases Among Extremely Low Birth Weight Infants A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The antioxidant system of very low birth weight infants is immature This immaturity is implicated in the pathogenesis of diseases such as bronchopulmonary dysplasia or retinopathy The main source of oxidant is oxygen and parenteral nutrition is contaminated with oxidant Photoprotection decreases the oxidant load infused with parenteral nutrition In a preliminary study photoprotection reduced the frequency of pulmonary bronchodysplasia increased the quantity of enteral nutrition tolerated and decreased the arterial blood pressure among very low birth weight infants The aim of this study is to evaluate the impact of photoprotection on oxidant related diseases among very low birth weight infants This study is a randomized multicenter trial In the intervention group photoprotection is applied until the infusion of parenteral nutrition with amber bags tubing and syringes The quality of photoprotection is controlled by measuring malondialdehyde and cysteine after 24 hours of infusion The control group will receive parenteral nutrition with transparent bags and tubing The outcomes are evaluated at 36 weeks and 680 infants will be enrolled with stratification among centers and gestational age
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None