NCT00328419

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

Consequences of Parenteral Nutrition Photoprotection on the Oxidant Related Diseases Among Extremely Low Birth Weight Infants : A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 591 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 1 Day – 6 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Infant, Premature

Interventions

Type	Name	Description
DEVICE	photoprotected bags, tubing, syringes	use of photoprotected parenteral nutrition device
DEVICE	standard tubing and bags	Use of standard (transparent) parenteral nutrition device

Timeline

• Start date: 2006-05-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2006-05-22
• Last updated: 2019-05-28

Locations

1 site across 1 country: France