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Perenteral Nutrition and Oxidative Stress in Preterm Infants

Primary Purpose

Preterm Infants

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Photo-protection

Photo-exposure

About this trial

This is an interventional prevention trial for Preterm Infants focused on measuring preterm, parenteral nutrition, TPN, lipid emulsions, photo-protection, oxidative stress

Eligibility Criteria

undefined - 7 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Preterm infants included are:

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

Exclusion Criteria:

Infants are excluded if they have:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Perenteral nutrition bottle and tubing are not protected from light

Perenteral nutrition bottle and tubing are protected from light

Outcomes

Primary Outcome Measures

Concentration of peroxides in the urine

Secondary Outcome Measures

Clinical morbidities (death, and bronchopulmonary dysplasia)

Full Information

NCT ID

NCT00611546

First Posted

January 24, 2008

Last Updated

January 28, 2008

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT00611546

Brief Title

Perenteral Nutrition and Oxidative Stress in Preterm Infants

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

January 2005 (Actual)

Study Completion Date

January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mansoura University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Infants

Keywords

preterm, parenteral nutrition, TPN, lipid emulsions, photo-protection, oxidative stress

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Perenteral nutrition bottle and tubing are not protected from light

Arm Title

Arm Type

Active Comparator

Arm Description

Perenteral nutrition bottle and tubing are protected from light

Intervention Type

Other

Intervention Name(s)

Photo-protection

Intervention Description

Parenteral solutions are protected from day light using aluminum covers

Intervention Type

Other

Intervention Name(s)

Photo-exposure

Intervention Description

Perenteral nutrition bottles and tubings are allowed to be exposed to day light.

Primary Outcome Measure Information:

Title

Concentration of peroxides in the urine

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Clinical morbidities (death, and bronchopulmonary dysplasia)

Time Frame

during hospital stay

10. Eligibility

Sex

All

Maximum Age & Unit of Time

7 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Preterm infants included are: with gestational age between 28 to 34 weeks managed with TPN as part of their care in the NICU their postnatal age on enrolment was < 7 days Exclusion Criteria: Infants are excluded if they have: Clinical evidence of sepsis, or a positive blood culture on admission Hepatobiliary dysfunction Persistent metabolic acidosis with base deficit > 10 mEq / L Renal impairment (urine output < 1 ml/kg/hour and serum creatinine > 1 mg/dl) Disseminated intravascular coagulopathy Maternal conditions known to be associated with oxidative stress such as preeclampsia, hypertension and diabetes.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed R Bassiouny, MD

Organizational Affiliation

Mansoura University Children's Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

19274793

Citation

Bassiouny MR, Almarsafawy H, Abdel-Hady H, Nasef N, Hammad TA, Aly H. A randomized controlled trial on parenteral nutrition, oxidative stress, and chronic lung diseases in preterm infants. J Pediatr Gastroenterol Nutr. 2009 Mar;48(3):363-9. doi: 10.1097/mpg.0b013e31818c8623.

Results Reference

derived

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Perenteral Nutrition and Oxidative Stress in Preterm Infants

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