NCT00328419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
591

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 28, 2019

Status Verified

December 1, 2011

Enrollment Period

3.9 years

First QC Date

May 19, 2006

Last Update Submit

May 23, 2019

Conditions

Infant, Premature

Keywords

Photoprotection,Parenteral nutritionOxidant stressInfant, Premature

Outcome Measures

Primary Outcomes (1)

  • Death or bronchopulmonary dysplasia at 28 days

    28 days

Secondary Outcomes (6)

  • Retinopathy of prematurity

    36 weeks

  • sepsis

    28 days and 36 weeks

  • intraventricular hemorrhage

    7 days, 24days, 36 weeks

  • periventricular leucomalacia

    36 weeks

  • tolerance of enteral nutrition

    during enteral nutrition

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

photoprotected parenteral nutrition

Device: photoprotected bags, tubing, syringes

2

ACTIVE COMPARATOR

Non-photoprotected parenteral nutrition

Device: standard tubing and bags

Interventions

photoprotected bags, tubing, syringesDEVICE

use of photoprotected parenteral nutrition device

1
standard tubing and bagsDEVICE

Use of standard (transparent) parenteral nutrition device

2

Eligibility Criteria

Age1 Day - 6 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants born before 30 weeks gestational age
  • Postnatal age between 1 and 6 days
  • Apgar score up to 2

You may not qualify if:

  • Severe congenital abnormalities
  • Intraventricular hemorrhage grade up to 2
  • Use of intravenous lipids or parenteral nutrition before randomisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angelique Denis

Lyon, 69003, France

Location

Related Publications (1)

  • 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.

    PMID: 24925504RESULT

MeSH Terms

Conditions

Premature BirthHyperphagia

Interventions

Syringes

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Sophie Laborie, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2006

First Posted

May 22, 2006

Study Start

May 1, 2006

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

May 28, 2019

Record last verified: 2011-12

Locations

FR(1)