Perenteral Nutrition and Oxidative Stress in Preterm Infants

NCT00611546 | Completed

• 1 other identifier: 2003-MD-thesis-nehad
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preterm Infants

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Concentration of peroxides in the urine

  48 hours

Secondary Outcomes (1)

• Clinical morbidities (death, and bronchopulmonary dysplasia)

  during hospital stay

Study Arms (2)

1

PLACEBO COMPARATOR

Perenteral nutrition bottle and tubing are not protected from light

Other: Photo-exposure

2

ACTIVE COMPARATOR

Perenteral nutrition bottle and tubing are protected from light

Other: Photo-protection

Interventions

Photo-protection OTHER

Parenteral solutions are protected from day light using aluminum covers

2

Photo-exposure OTHER

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

1

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Related Publications (1)

• 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.

  PMID: 19274793 DERIVED

MeSH Terms

Conditions

Premature Birth; Hyperphagia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed R Bassiouny, MD

  Mansoura University Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 11, 2008
• Study Start: April 1, 2003
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: February 11, 2008

Record last verified: 2008-01