Infant, Premature
Conditions
Keywords
Photoprotection,, Parenteral nutrition, Oxidant stress, Infant, Premature
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.
Interventions
DEVICEphotoprotected bags, tubing, syringes
use of photoprotected parenteral nutrition device
DEVICEstandard tubing and bags
Use of standard (transparent) parenteral nutrition device
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 6 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death or bronchopulmonary dysplasia at 28 days | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| sepsis | 28 days and 36 weeks |
| intraventricular hemorrhage | 7 days, 24days, 36 weeks |
| Retinopathy of prematurity | 36 weeks |
| tolerance of enteral nutrition | during enteral nutrition |
| enterocolitis | 36 weeks |
| periventricular leucomalacia | 36 weeks |
Countries
France
Outcome results
None listed