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

Infant, Premature Clinical Trial

Official title:

Consequences of Parenteral Nutrition Photoprotection on the Oxidant Related Diseases Among Extremely Low Birth Weight Infants : A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328419
• Other study ID #: 2004.358
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Birth Weight
• Infant, Premature

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