Perenteral Nutrition and Oxidative Stress in Preterm Infants

January 28, 2008 updated by: Mansoura University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Perenteral nutrition bottle and tubing are not protected from light
Other: Photo-exposure
Perenteral nutrition bottles and tubings are allowed to be exposed to day light.
Active Comparator: 2
Perenteral nutrition bottle and tubing are protected from light
Other: Photo-protection
Parenteral solutions are protected from day light using aluminum covers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of peroxides in the urine
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical morbidities (death, and bronchopulmonary dysplasia)
Time Frame: during hospital stay
during hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Mohamed R Bassiouny, MD, Mansoura University Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

January 28, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

February 11, 2008

Last Update Submitted That Met QC Criteria

January 28, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-MD-thesis-nehad

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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