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Consequences of Parenteral Nutrition Photoprotection on Oxidant Related Diseases Among Extremely Low Birth Weight Infants
This study is currently recruiting participants.
Verified by Hospices Civils de Lyon, June 2008
Sponsored by: Hospices Civils de Lyon
Information provided by: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00328419
  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

MedlinePlus related topics: Premature Babies
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Consequences of Parenteral Nutrition Photoprotection on the Oxidant Related Diseases Among Extremely Low Birth Weight Infants : A Randomized Controlled Study

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 ]

Estimated Enrollment: 680
Study Start Date: May 2006
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
photoprotected parenteral nutrition
Device: photoprotected bags, tubing, syringes
use of photoprotected parenteral nutrition device
2: Active Comparator
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

Contacts
Contact: Angelique Denis 33 4.72.11.57.66 angelique.denis@chu-lyon.fr

Locations
France
Angelique Denis Recruiting
Lyon, France, 69003
Contact: Angelique Denis     33 4.72.11.57.66     angelique.denis@chu-lyon.fr    
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Sophie Laborie, MD Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon ( Sophie LABORIE, MD )
Study ID Numbers: 2004.358
Study First Received: May 19, 2006
Last Updated: June 20, 2008
ClinicalTrials.gov Identifier: NCT00328419  
Health Authority: France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:
Body Weight
Birth Weight
Signs and Symptoms
Stress

ClinicalTrials.gov processed this record on January 15, 2009



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