Perenteral Nutrition and Oxidative Stress in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Preterm Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Perenteral nutrition bottle and tubing are not protected from light

Group Type PLACEBO_COMPARATOR

Photo-exposure

Intervention Type OTHER

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

2

Perenteral nutrition bottle and tubing are protected from light

Group Type ACTIVE_COMPARATOR

Photo-protection

Intervention Type OTHER

Parenteral solutions are protected from day light using aluminum covers

Interventions

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Photo-protection

Parenteral solutions are protected from day light using aluminum covers

Intervention Type OTHER

Photo-exposure

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

Intervention Type OTHER

Eligibility Criteria

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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.

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No