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NCT Number: NCT00328419

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

photoprotected bags, tubing, syringes

Device

use of photoprotected parenteral nutrition device

standard tubing and bags

Device

Use of standard (transparent) parenteral nutrition device

Primary outcomes

  1. Death or bronchopulmonary dysplasia at 28 days

    Time frame: 28 days

Secondary outcomes

  1. Retinopathy of prematurity

    Time frame: 36 weeks

  2. sepsis

    Time frame: 28 days and 36 weeks

  3. intraventricular hemorrhage

    Time frame: 7 days, 24days, 36 weeks

  4. periventricular leucomalacia

    Time frame: 36 weeks

  5. tolerance of enteral nutrition

    Time frame: during enteral nutrition

  6. enterocolitis

    Time frame: 36 weeks

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
May 22, 2006
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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