Perenteral Nutrition and Oxidative Stress in Preterm Infants

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00611546

Enrollment

Registered

2008-02-11

Start date

2003-04-30

Completion date

2005-01-31

Last updated

2008-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants

Keywords

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

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.

Interventions

OTHERPhoto-exposure

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

OTHERPhoto-protection

Parenteral solutions are protected from day light using aluminum covers

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 7 Days

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.

Design outcomes

Primary

Measure	Time frame
Concentration of peroxides in the urine	48 hours

Secondary

Measure	Time frame
Clinical morbidities (death, and bronchopulmonary dysplasia)	during hospital stay

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026