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Clinical Trials/NCT00328419
NCT00328419
Completed
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country591 target enrollmentMay 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant, Premature
Sponsor
Hospices Civils de Lyon
Enrollment
591
Locations
1
Primary Endpoint
Death or bronchopulmonary dysplasia at 28 days
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2006
End Date
May 2010
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Death or bronchopulmonary dysplasia at 28 days

Time Frame: 28 days

Secondary Outcomes

  • sepsis(28 days and 36 weeks)
  • intraventricular hemorrhage(7 days, 24days, 36 weeks)
  • Retinopathy of prematurity(36 weeks)
  • tolerance of enteral nutrition(during enteral nutrition)
  • enterocolitis(36 weeks)
  • periventricular leucomalacia(36 weeks)

Study Sites (1)

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