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CompletedNCT00611546Updated Feb 11, 2008

Perenteral Nutrition and Oxidative Stress in Preterm Infants

An interventional study of Photo-protection and Photo-exposure in Preterm Infants, sponsored by Mansoura University. Completed. Open to participants aged Up to 7 Days. Per ClinicalTrials.gov, last updated 2008-02-11.

Sponsored by Mansoura University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
Up to 7 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Preterm Infants

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Keywords

  • preterm
  • parenteral nutrition
  • TPN
  • lipid emulsions
  • photo-protection
  • oxidative stress
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 80 is close to the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 7 Days
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Placebo comparator
    1

    Perenteral nutrition bottle and tubing are not protected from light

    Other: Photo-exposure

  • Active comparator
    2

    Perenteral nutrition bottle and tubing are protected from light

    Other: Photo-protection

Interventions

  • OtherPhoto-protection

    Parenteral solutions are protected from day light using aluminum covers

  • OtherPhoto-exposure

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

06

What researchers measure

Primary outcomes

  1. Concentration of peroxides in the urine

    Time frame: 48 hours

Secondary outcomes

  1. Clinical morbidities (death, and bronchopulmonary dysplasia)

    Time frame: during hospital stay

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 19274793 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00611546
Lead sponsor
Mansoura University
First posted
Feb 11, 2008
Start date
Apr 2003
Primary completion
Jan 2005
Completion
Jan 2005
Last update
Feb 11, 2008

Study contacts

Mohamed R Bassiouny, MD
study chair · Mansoura University Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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