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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00328419
First received: May 19, 2006
Last updated: December 28, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Infant, Premature
 Device: photoprotected bags, tubing, syringes
Device: standard tubing and bags

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Consequences of Parenteral Nutrition Photoprotection on the Oxidant Related Diseases Among Extremely Low Birth Weight Infants : A Randomized Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Death or bronchopulmonary dysplasia at 28 days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Retinopathy of prematurity [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • sepsis [ Time Frame: 28 days and 36 weeks ] [ Designated as safety issue: Yes ]
  • intraventricular hemorrhage [ Time Frame: 7 days, 24days, 36 weeks ] [ Designated as safety issue: Yes ]
  • periventricular leucomalacia [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • tolerance of enteral nutrition [ Time Frame: during enteral nutrition ] [ Designated as safety issue: Yes ]
  • enterocolitis [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 591
Study Start Date: May 2006
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
photoprotected parenteral nutrition
 Device: photoprotected bags, tubing, syringes
use of photoprotected parenteral nutrition device
Active Comparator: 2
Non-photoprotected parenteral nutrition
 Device: standard tubing and bags
Use of standard (transparent) parenteral nutrition device

  Eligibility

Ages Eligible for Study:   up to 6 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328419

Locations
France
Angelique Denis
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Sophie Laborie, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00328419     History of Changes
Other Study ID Numbers: 2004.358
Study First Received: May 19, 2006
Last Updated: December 28, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Photoprotection,
Parenteral nutrition
Oxidant stress
Infant, Premature

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013