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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00328419
Other study ID # 2004.358
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2006
Est. completion date May 2010

Study information

Verified date December 2011
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 591
Est. completion date May 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Days
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
photoprotected bags, tubing, syringes
use of photoprotected parenteral nutrition device
standard tubing and bags
Use of standard (transparent) parenteral nutrition device

Locations

Country Name City State
France Angelique Denis Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & 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 Controlle — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Death or bronchopulmonary dysplasia at 28 days 28 days
Secondary Retinopathy of prematurity 36 weeks
Secondary sepsis 28 days and 36 weeks
Secondary intraventricular hemorrhage 7 days, 24days, 36 weeks
Secondary periventricular leucomalacia 36 weeks
Secondary tolerance of enteral nutrition during enteral nutrition
Secondary enterocolitis 36 weeks
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