Consequences of Parenteral Nutrition Photoprotection on Oxidant Related Diseases Among Extremely Low Birth Weight Infants

Not Applicable

Completed

• Conditions: Infant, Premature
• Interventions: Device: photoprotected bags, tubing, syringes; Device: standard tubing and bags

• Registration Number: NCT00328419
• Lead Sponsor: Hospices Civils de Lyon

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

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-19
• Study First Submitted QC: 2006-05-19
• Study First Posted: 2006-05-22
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Status Verified: 2011-12
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 591

Inclusion Criteria

• Infants born before 30 weeks gestational age
• Postnatal age between 1 and 6 days
• Apgar score up to 2

Exclusion Criteria

• Severe congenital abnormalities
• Intraventricular hemorrhage grade up to 2
• Proven sepsis before inclusion
• Transfusion before inclusion
• Use of intravenous lipids or parenteral nutrition before randomisation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	photoprotected bags, tubing, syringes	photoprotected parenteral nutrition
2	standard tubing and bags	Non-photoprotected parenteral nutrition

Primary Outcome Measures

Name	Time	Method
Death or bronchopulmonary dysplasia at 28 days	28 days

Secondary Outcome Measures

Name	Time	Method
sepsis	28 days and 36 weeks
intraventricular hemorrhage	7 days, 24days, 36 weeks
periventricular leucomalacia	36 weeks
Retinopathy of prematurity	36 weeks
tolerance of enteral nutrition	during enteral nutrition
enterocolitis	36 weeks

Trial Locations

Locations (1)

Angelique Denis; 🇫🇷 Lyon, France