Perenteral Nutrition and Oxidative Stress in Preterm Infants

Preterm Infants Clinical Trial

Official title:

Study of the Oxidant-Antioxidant Effects of Parenteral Nutrition in Preterm Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611546
• Other study ID #: 2003-MD-thesis-nehad
• Status: Completed
• Phase: N/A
• First received: January 24, 2008
• Last updated: January 28, 2008
• Start date: April 2003
• Est. completion date: January 2005

Study information

• Verified date: January 2008
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants

Intervention

Other:
• Photo-protection
Parenteral solutions are protected from day light using aluminum covers
• Photo-exposure
Perenteral nutrition bottles and tubings are allowed to be exposed to day light.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of peroxides in the urine		48 hours	No
Secondary	Clinical morbidities (death, and bronchopulmonary dysplasia)		during hospital stay	Yes