Perenteral Nutrition and Oxidative Stress in Preterm Infants

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT00611546
First received: January 24, 2008
Last updated: January 28, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention
Preterm Infants
Other: Photo-protection
Other: Photo-exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of the Oxidant-Antioxidant Effects of Parenteral Nutrition in Preterm Neonates

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Concentration of peroxides in the urine [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical morbidities (death, and bronchopulmonary dysplasia) [ Time Frame: during hospital stay ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: April 2003
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611546

Sponsors and Collaborators
Mansoura University
Investigators
Study Chair: Mohamed R Bassiouny, MD Mansoura University Children's Hospital
  More Information

No publications provided by Mansoura University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nehad Nasef, Mansoura University Children's Hospital
ClinicalTrials.gov Identifier: NCT00611546     History of Changes
Other Study ID Numbers: 2003-MD-thesis-nehad
Study First Received: January 24, 2008
Last Updated: January 28, 2008
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Mansoura University:
preterm
parenteral nutrition
TPN
lipid emulsions
photo-protection
oxidative stress

ClinicalTrials.gov processed this record on July 23, 2014