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

Primary Purpose

Infant, Premature

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
photoprotected bags, tubing, syringes
standard tubing and bags
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant, Premature focused on measuring Photoprotection,, Parenteral nutrition, Oxidant stress, Infant, Premature

Eligibility Criteria

1 Day - 6 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Angelique Denis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

photoprotected parenteral nutrition

Non-photoprotected parenteral nutrition

Outcomes

Primary Outcome Measures

Death or bronchopulmonary dysplasia at 28 days

Secondary Outcome Measures

Retinopathy of prematurity
sepsis
intraventricular hemorrhage
periventricular leucomalacia
tolerance of enteral nutrition
enterocolitis

Full Information

First Posted
May 19, 2006
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00328419
Brief Title
Consequences of Parenteral Nutrition Photoprotection on Oxidant Related Diseases Among Extremely Low Birth Weight Infants
Official Title
Consequences of Parenteral Nutrition Photoprotection on the Oxidant Related Diseases Among Extremely Low Birth Weight Infants : A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature
Keywords
Photoprotection,, Parenteral nutrition, Oxidant stress, Infant, Premature

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
591 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
photoprotected parenteral nutrition
Arm Title
2
Arm Type
Active Comparator
Arm Description
Non-photoprotected parenteral nutrition
Intervention Type
Device
Intervention Name(s)
photoprotected bags, tubing, syringes
Intervention Description
use of photoprotected parenteral nutrition device
Intervention Type
Device
Intervention Name(s)
standard tubing and bags
Intervention Description
Use of standard (transparent) parenteral nutrition device
Primary Outcome Measure Information:
Title
Death or bronchopulmonary dysplasia at 28 days
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Retinopathy of prematurity
Time Frame
36 weeks
Title
sepsis
Time Frame
28 days and 36 weeks
Title
intraventricular hemorrhage
Time Frame
7 days, 24days, 36 weeks
Title
periventricular leucomalacia
Time Frame
36 weeks
Title
tolerance of enteral nutrition
Time Frame
during enteral nutrition
Title
enterocolitis
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Laborie, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Angelique Denis
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24925504
Citation
Laborie S, Denis A, Dassieu G, Bedu A, Tourneux P, Pinquier D, Kermorvant E, Millet V, Klosowski S, Patural H, Clamadieu C, Brunhes A, Walther M, Jaisson-Hot I, Mandy B, Claris O. Shielding Parenteral Nutrition Solutions From Light: A Randomized Controlled Trial. JPEN J Parenter Enteral Nutr. 2015 Aug;39(6):729-37. doi: 10.1177/0148607114537523. Epub 2014 Jun 12.
Results Reference
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Consequences of Parenteral Nutrition Photoprotection on Oxidant Related Diseases Among Extremely Low Birth Weight Infants

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