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Perenteral Nutrition and Oxidative Stress in Preterm Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00611546
First Posted: February 11, 2008
Last Update Posted: February 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mansoura University
  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: None (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 ]

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

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

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611546


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

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
First Submitted: January 24, 2008
First Posted: February 11, 2008
Last Update Posted: February 11, 2008
Last Verified: January 2008

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications