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

May 23, 2019 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

591

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Angelique Denis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 6 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death or bronchopulmonary dysplasia at 28 days
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Retinopathy of prematurity
Time Frame: 36 weeks
36 weeks
sepsis
Time Frame: 28 days and 36 weeks
28 days and 36 weeks
intraventricular hemorrhage
Time Frame: 7 days, 24days, 36 weeks
7 days, 24days, 36 weeks
periventricular leucomalacia
Time Frame: 36 weeks
36 weeks
tolerance of enteral nutrition
Time Frame: during enteral nutrition
during enteral nutrition
enterocolitis
Time Frame: 36 weeks
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sophie Laborie, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 19, 2006

First Submitted That Met QC Criteria

May 19, 2006

First Posted (Estimate)

May 22, 2006

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004.358

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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