Perenteral Nutrition and Oxidative Stress in Preterm Infants

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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Key information

Conditions

Preterm Infants Female Urogenital Diseases and Pregnancy Complications Hyperphagia Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photo-protection

Other

Parenteral solutions are protected from day light using aluminum covers

Photo-exposure

Other

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

Primary outcomes

Concentration of peroxides in the urine

Time frame: 48 hours

Secondary outcomes

Clinical morbidities (death, and bronchopulmonary dysplasia)

Time frame: during hospital stay

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2005
First posted: Feb 11, 2008
Registry last updated: Feb 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed