Preterm InfantsNCT00611546
Perenteral Nutrition and Oxidative Stress in Preterm Infants
A study testing Photo-protection and Photo-exposure in people with Preterm Infants, run by Mansoura University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Preterm Infants
- What is being tested?
- Photo-protection and Photo-exposure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Jan 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Study of the Oxidant-Antioxidant Effects of Parenteral Nutrition in Preterm Neonates
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
- Being tested
- Photo-protection, Photo-exposure
- Keywords
- preterm, parenteral nutrition, TPN, lipid emulsions, photo-protection, oxidative stress
- Medical subject headings
- Premature Birth, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photo-protectionOther
Parenteral solutions are protected from day light using aluminum covers
Photo-exposureOther
Perenteral nutrition bottles and tubings are allowed to be exposed to day light.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Perenteral nutrition bottle and tubing are not protected from light Receives: Other: Photo-exposure |
| 2 | Active comparator | Perenteral nutrition bottle and tubing are protected from light Receives: Other: Photo-protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of peroxides in the urine
Measured: 48 hours
Secondary outcomes (1)
Clinical morbidities (death, and bronchopulmonary dysplasia)
Measured: during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startApr 2003
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- Mohamed R Bassiouny, MD, Study chair, Mansoura University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611546
- Sponsor's protocol ID
- 2003-MD-thesis-nehad
- Status last verified
- Jan 2008
- First submitted
- 24 Jan 2008
- Last updated
- 11 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Oxidant-Antioxidant Effects of Parenteral Nutrition in Preterm Neonates
- ClinicalTrials.gov ID
- NCT00611546
- Acronym / sponsor ID
- 2003-MD-thesis-nehad
- Conditions
- Preterm Infants
- Keywords
- preterm, parenteral nutrition, TPN, lipid emulsions, photo-protection, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: Photo-exposurePerenteral nutrition bottle and tubing are not protected from light |
| 2 | Active comparator | Other: Photo-protectionPerenteral nutrition bottle and tubing are protected from light |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photo-protectionParenteral solutions are protected from day light using aluminum covers | Other | 2 |
| Photo-exposurePerenteral nutrition bottles and tubings are allowed to be exposed to day light. | Other | 1 |
Primary outcome
Concentration of peroxides in the urine
Time frame: 48 hours
1 secondary outcome
Clinical morbidities (death, and bronchopulmonary dysplasia)
Time frame: during hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2008.
- Derived from this study: PubMed 19274793Bassiouny 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.
Related trials for Preterm Infants
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Growing Little PEAPODS Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed R Bassiouny, MD study chair
Mansoura University Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Photo-protection and Photo-exposure in people with Preterm Infants, run by Mansoura University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of peroxides in the urine (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00611546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2008.