Infant, PrematureNCT00328419
Consequences of Parenteral Nutrition Photoprotection on Oxidant Related Diseases Among Extremely Low Birth Weight Infants
A study testing photoprotected bags, tubing, syringes and standard tubing and bags in people with Infant, Premature, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The antioxidant system of very low birth weight infants is immature. This immaturity is implicated in the pathogenesis of diseases such as bronchopulmonary dysplasia or retinopathy. The main source of oxidant is oxygen, and parenteral nutrition is contaminated with oxidant. Read more about this study
- Who is it for?
- Ages 1 day to 6 days
- Conditions the study is for
- Infant, Premature
- What is being tested?
- photoprotected bags, tubing, syringes and standard tubing and bags
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 591 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to May 2010
- 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 1 day to 6 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born before 30 weeks gestational age
- Postnatal age between 1 and 6 days
- Apgar score up to 2
Who cannot join
- Severe congenital abnormalities
- Intraventricular hemorrhage grade up to 2
- Proven sepsis before inclusion
- Transfusion before inclusion
- Use of intravenous lipids or parenteral nutrition before randomisation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consequences of Parenteral Nutrition Photoprotection on the Oxidant Related Diseases Among Extremely Low Birth Weight Infants : A Randomized Controlled Study
The antioxidant system of very low birth weight infants is immature. This immaturity is implicated in the pathogenesis of diseases such as bronchopulmonary dysplasia or retinopathy. The main source of oxidant is oxygen, and parenteral nutrition is contaminated with oxidant. Photoprotection decreases the oxidant load infused with parenteral nutrition. In a preliminary study, photoprotection reduced the frequency of pulmonary bronchodysplasia, increased the quantity of enteral nutrition tolerated, and decreased the arterial blood pressure among very low birth weight infants. The aim of this study is to evaluate the impact of photoprotection on oxidant related diseases among very low birth weight infants. This study is a randomized multicenter trial. In the intervention group, photoprotection is applied until the infusion of parenteral nutrition with amber bags, tubing, and syringes. The quality of photoprotection is controlled by measuring malondialdehyde and cysteine after 24 hours of infusion. The control group will receive parenteral nutrition with transparent bags and tubing. The outcomes are evaluated at 36 weeks, and 680 infants will be enrolled, with stratification among centers and gestational age.
- Conditions
- Infant, Premature
- Being tested
- photoprotected bags, tubing, syringes, standard tubing and bags
- Keywords
- Photoprotection,, Parenteral nutrition, Oxidant stress, Infant, Premature
- 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.
photoprotected bags, tubing, syringesDevice
use of photoprotected parenteral nutrition device
standard tubing and bagsDevice
Use of standard (transparent) parenteral nutrition device
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | photoprotected parenteral nutrition Receives: Device: photoprotected bags, tubing, syringes |
| 2 | Active comparator | Non-photoprotected parenteral nutrition Receives: Device: standard tubing and bags |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or bronchopulmonary dysplasia at 28 days
Measured: 28 days
Secondary outcomes (6)
Retinopathy of prematurity
Measured: 36 weeks
sepsis
Measured: 28 days and 36 weeks
intraventricular hemorrhage
Measured: 7 days, 24days, 36 weeks
periventricular leucomalacia
Measured: 36 weeks
tolerance of enteral nutrition
Measured: during enteral nutrition
enterocolitis
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startMay 2006
- Primary completionApr 2010
- Study completionMay 2010
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 Infant, PrematureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 591 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Laborie, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328419
- Sponsor's protocol ID
- 2004.358
- Status last verified
- Dec 2011
- First submitted
- 19 May 2006
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Laborie S, Denis A, Dassieu G, Bedu A, Tourneux P, Pinquier D, Kermorvant E, Millet V, Klosowski S, Patural H, Clamadieu C, Brunhes A, Walther M, Jaisson-Hot I, Mandy B, Claris O. Shielding Parenteral Nutrition Solutions From Light: A Randomized Controlled Trial. JPEN J Parenter Enteral Nutr. 2015 Aug;39(6):729-37. doi: 10.1177/0148607114537523. Epub 2014 Jun 12.
PubMed 24925504
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Parenteral Nutrition Photoprotection on the Oxidant Related Diseases Among Extremely Low Birth Weight Infants : A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00328419
- Acronym / sponsor ID
- 2004.358
- Conditions
- Infant, Premature
- Keywords
- Photoprotection,, Parenteral nutrition, Oxidant stress, Infant, Premature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 May 2006 (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.
The antioxidant system of very low birth weight infants is immature. This immaturity is implicated in the pathogenesis of diseases such as bronchopulmonary dysplasia or retinopathy. The main source of oxidant is oxygen, and parenteral nutrition is contaminated with oxidant. Photoprotection decreases the oxidant load infused with parenteral nutrition. In a preliminary study, photoprotection reduced the frequency of pulmonary bronchodysplasia, increased the quantity of enteral nutrition tolerated, and decreased the arterial blood pressure among very low birth weight infants. The aim of this study is to evaluate the impact of photoprotection on oxidant related diseases among very low birth weight infants. This study is a randomized multicenter trial. In the intervention group, photoprotection is applied until the infusion of parenteral nutrition with amber bags, tubing, and syringes. The quality of photoprotection is controlled by measuring malondialdehyde and cysteine after 24 hours of infusion. The control group will receive parenteral nutrition with transparent bags and tubing. The outcomes are evaluated at 36 weeks, and 680 infants will be enrolled, with stratification among centers and gestational age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: photoprotected bags, tubing, syringesphotoprotected parenteral nutrition |
| 2 | Active comparator | Device: standard tubing and bagsNon-photoprotected parenteral nutrition |
Who may qualify
- Ages
- 1 day to 6 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants born before 30 weeks gestational age
- Postnatal age between 1 and 6 days
- Apgar score up to 2
Key exclusion criteria (5 listed)
- Severe congenital abnormalities
- Intraventricular hemorrhage grade up to 2
- Proven sepsis before inclusion
- Transfusion before inclusion
- Use of intravenous lipids or parenteral nutrition before randomisation
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 |
|---|---|---|
| photoprotected bags, tubing, syringesuse of photoprotected parenteral nutrition device | Device | 1 |
| standard tubing and bagsUse of standard (transparent) parenteral nutrition device | Device | 2 |
Primary outcome
Death or bronchopulmonary dysplasia at 28 days
Time frame: 28 days
6 secondary outcomes
Retinopathy of prematurity
Time frame: 36 weeks
sepsis
Time frame: 28 days and 36 weeks
intraventricular hemorrhage
Time frame: 7 days, 24days, 36 weeks
periventricular leucomalacia
Time frame: 36 weeks
tolerance of enteral nutrition
Time frame: during enteral nutrition
enterocolitis
Time frame: 36 weeks
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 28 May 2019.
- Results publication: PubMed 24925504Laborie S, Denis A, Dassieu G, Bedu A, Tourneux P, Pinquier D, Kermorvant E, Millet V, Klosowski S, Patural H, Clamadieu C, Brunhes A, Walther M, Jaisson-Hot I, Mandy B, Claris O. Shielding Parenteral Nutrition Solutions From Light: A Randomized Controlled Trial. JPEN J Parenter Enteral Nutr. 2015 Aug;39(6):729-37. doi: 10.1177/0148607114537523. Epub 2014 Jun 12.
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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.
Sophie Laborie, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photoprotected bags, tubing, syringes and standard tubing and bags in people with Infant, Premature, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 5 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 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Death or bronchopulmonary dysplasia at 28 days (time frame: 28 days). 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 NCT00328419, 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 28 May 2019.