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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

591 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infant, Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

photoprotected parenteral nutrition

Group Type EXPERIMENTAL

photoprotected bags, tubing, syringes

Intervention Type DEVICE

use of photoprotected parenteral nutrition device

2

Non-photoprotected parenteral nutrition

Group Type ACTIVE_COMPARATOR

standard tubing and bags

Intervention Type DEVICE

Use of standard (transparent) parenteral nutrition device

Interventions

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photoprotected bags, tubing, syringes

use of photoprotected parenteral nutrition device

Intervention Type DEVICE

standard tubing and bags

Use of standard (transparent) parenteral nutrition device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No