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

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ClinicalTrials.gov Identifier: NCT00328419
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : December 30, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infant, Premature Device: photoprotected bags, tubing, syringes Device: standard tubing and bags Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 591 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2006
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Death or bronchopulmonary dysplasia at 28 days [ Time Frame: 28 days ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 6 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00328419     History of Changes
Other Study ID Numbers: 2004.358
First Posted: May 22, 2006    Key Record Dates
Last Update Posted: December 30, 2011
Last Verified: December 2011

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