Clinical trial NCT00328419: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Keywords: Photoprotection,
Parenteral nutrition
Oxidant stress
Infant, Premature
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2006-05-22
Enrollment: 591
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Death or bronchopulmonary dysplasia at 28 days
timeFrame: 28 days
Secondary outcomes:
measure: Retinopathy of prematurity
timeFrame: 36 weeks
measure: sepsis
timeFrame: 28 days and 36 weeks
measure: intraventricular hemorrhage
timeFrame: 7 days, 24days, 36 weeks
measure: periventricular leucomalacia
timeFrame: 36 weeks
measure: tolerance of enteral nutrition
timeFrame: during enteral nutrition
measure: enterocolitis
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Lyon
country: France
facility: Angelique Denis
Study officials:
affiliation: Hospices Civils de Lyon
name: Sophie Laborie, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.