Perenteral Nutrition and Oxidative Stress in Preterm Infants

Mansoura University

Status: Completed

Conditions: Preterm Infants

Treatments: Other: Photo-protection; Other: Photo-exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT00611546

2003-MD-thesis-nehad

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: Under 7 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Perenteral nutrition bottle and tubing are not protected from light

Treatment:

Other: Photo-exposure

2

Active Comparator group

Description:

Perenteral nutrition bottle and tubing are protected from light

Treatment:

Other: Photo-protection