Perenteral Nutrition and Oxidative Stress in Preterm Infants

Not Applicable

Completed

• Conditions: Preterm Infants
• Interventions: Other: Photo-protection; Other: Photo-exposure

• Registration Number: NCT00611546
• Lead Sponsor: Mansoura University

Brief Summary

In an effort to decrease the load of peroxides in TPN solutions, multiple studies examined different strategies such as photo-protection, adding multivitamins to the lipid emulsion rather than to the dextrose-amino acid admixture, and adding antioxidants such as glutathione to the TPN solution. However, the role of trace elements as antioxidants, and their interaction with light have not been studied. Also, the impact of TPN-related oxidants on clinical morbidities has not been addressed. Therefore, we aimed in this study of preterm infants to evaluate the role of different components of TPN on urinary peroxides and to examine the biochemical and clinical effects of light protection.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Status Verified: 2008-01
• Study First Submitted: 2008-01-24
• Study First Submitted QC: 2008-01-28
• Last Update Submitted: 2008-01-28
• Study First Posted: 2008-02-11
• Last Update Posted: 2008-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Preterm infants included are:

1. with gestational age between 28 to 34 weeks
2. managed with TPN as part of their care in the NICU
3. their postnatal age on enrolment was < 7 days

Exclusion Criteria

Infants are excluded if they have:

1. Clinical evidence of sepsis, or a positive blood culture on admission
2. Hepatobiliary dysfunction
3. Persistent metabolic acidosis with base deficit > 10 mEq / L
4. Renal impairment (urine output < 1 ml/kg/hour and serum creatinine > 1 mg/dl)
5. Disseminated intravascular coagulopathy
6. Maternal conditions known to be associated with oxidative stress such as preeclampsia, hypertension and diabetes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Photo-protection	Perenteral nutrition bottle and tubing are protected from light
1	Photo-exposure	Perenteral nutrition bottle and tubing are not protected from light

Primary Outcome Measures

Name	Time	Method
Concentration of peroxides in the urine	48 hours

Secondary Outcome Measures

Name	Time	Method
Clinical morbidities (death, and bronchopulmonary dysplasia)	during hospital stay