Oxidative Stress in Preterm InfantsNCT02694510
Light Protection of TPN and Oxidative Stress in Preterm Infants
A study testing Light-protection of TPN solutions in people with Oxidative Stress in Preterm Infants, run by Mansoura University Children Hospital at 1 site in Egypt.
Trial summary
Urinary peroxides and plasma glutathione/glutathione disulfide (GSH/GSSG) ratio will be measured in preterm infants less than 32 weeks gestation before and 7 days after receiving either Light-protected (Group 1) or Light-exposed (Group 2) Total Parenteral Nutrition (TPN) solutions. Read more about this study
- Who is it for?
- Ages 24 hours to 7 days
- Conditions the study is for
- Oxidative Stress in Preterm Infants
- What is being tested?
- Light-protection of TPN solutions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2014to 1 Jan 2018
- 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 24 hours to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infant less than 32 weeks gestational age
Who cannot join
- Infant with major congenital anomalies
- Infant of diabetic or hypertensive mother
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Children Hospital
Al Mansurah, El Dakahlya, 35111
About this study
Official title: Impact of Protecting TPN Solution From Light on the Oxidant-antioxidant State of Preterm Infant
Urinary peroxides and plasma glutathione/glutathione disulfide (GSH/GSSG) ratio will be measured in preterm infants less than 32 weeks gestation before and 7 days after receiving either Light-protected (Group 1) or Light-exposed (Group 2) Total Parenteral Nutrition (TPN) solutions.
Read the detailed description
This study will be a prospective single blinded randomized control trial.
Inborn preterm infant less than 32 wks gestational age, receiving TPN in neonatal intensive care unit (NICU) of Mansoura University Children's Hospital as a part of their care will be included.
Preterm infant will be randomly divided into 2group:- Group 1 includes preterm infant who will receive their TPN through bags and tubing system that are protected from light by aluminum foil.
Group 2 includes preterm infant who will receive their TPN through bags and tubing system that are exposed to light.
Randomization will be done using random table technique with opaque sealed envelopes containing the serial number and the group to which the subject will be enrolled.
These envelopes will be kept in the unit ready for use at any time; each one has a number which is the serial number of the baby and group of TPN to which the baby will be enrolled.
The urine sample will be sent to the laboratory with this serial number with no information about the group of study to which this sample follows for peroxide level as well as blood sample for GSH\GSSG.
Two blood samples and two urine samples will be collected. The first one will be at 0 hour before starting TPN regimen as a base line and the second will be at 7 days of starting TPN regimen. Blood sample will be at least 1cc of blood for GSH/GSSG assay. Urine collection bag will be placed on the infant to obtain minimum of 1cc of urine for urinary peroxide level assay.
Other secondary outcomes will be assessed with duration of NICU admission including death and /or bronchopulmonary dysplasia in preterm infant at time of hospital discharge, necrotizing enterocolitis (NEC), sepsis with positive blood cultures, length of hospital stay, retinopathy of prematurity (ROP), time to full enteral feeding, duration of respiratory support, liver function, cholestasis defined as an elevated serum conjugated bilirubin >2 mg/dL, and metabolic response.
- Conditions
- Oxidative Stress in Preterm Infants
- Being tested
- Light-protection of TPN solutions
- Keywords
- Preterm infants, Oxidative stress, Parenteral nutrition
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light-protection of TPN solutionsOther
TPN bags and infusion sets in the Light-protected group will be covered by aluminum foils to protect the inside TPN solution from exposure to ambient or photo-therapy lights in the NICU. Protection will be made throughout the study period until the infant reaches full feeding and TPN is discontinued.
| Study group | Role | What they receive |
|---|---|---|
| Light-protection | Active comparator | Light-protection of TPN solutions. TPN bags and infusion sets will be protected from light by aluminum foils throughout the study period. Receives: Other: Light-protection of TPN solutions |
| Light-exposure | Active comparator | TPN bags and infusion sets will be exposed to light throughout the study period. Receives: Other: Light-protection of TPN solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidant-antioxidant state
Measurement of urinary peroxides and serum GSH/GSSG ratio
Measured: 7 days
Secondary outcomes (9)
Death and/or Bronchopulmonary dysplasia
Death before hospital discharge and/or development of Bronchopulmonary dysplasia defined as oxygen requirement more than 30% fraction of inspired oxygen (FIO2) by 36 weeks corrected gestational age
Measured: 60 days
Necrotizing enterocolitis as Bell's stage 2 or more
Necrotizing enterocolitis defined by the modified by Bell's staging criteria
Measured: 60 days
Sepsis
clinical signs of sepsis confirmed by positive blood culture
Measured: 60 dyas
Retinopathy of prematurity pre-threshold and threshold stages
Pre-threshold and threshold stages of retinopathy of prematurity will be assessed as per our NICU routine by ophthalmology specialist.
Measured: 60 dyas
Time to full feeding
Time required to reach full enteral feeding and discontinue TPN
Measured: 30 days
Duration of respiratory support
Duration of mechanical ventilation, non-invasive ventilation, and oxygen therapy
Measured: 60 days
Neonatal cholestasis
Defined as an elevated serum conjugated bilirubin >2 mg/dL (34.2 micromoles/ l)
Measured: 60 days
Metabolic disturbance
Episodes of hypoglycemia less than 60 mmol/L, metabolic acidosis with pH less than 7.25 and base deficit more than 10 milliequivalent/L
Measured: 60 days
Length of hospital stay
Duration of admission to the neonatal care unit.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study start1 Jan 2014
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative Stress in Preterm InfantsStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehad Nasef, Mansoura University Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694510
- Sponsor's protocol ID
- MS/299
- Status last verified
- Jan 2018
- First submitted
- 16 Feb 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Protecting TPN Solution From Light on the Oxidant-antioxidant State of Preterm Infant
- ClinicalTrials.gov ID
- NCT02694510
- Acronym / sponsor ID
- MS/299
- Conditions
- Oxidative Stress in Preterm Infants
- Keywords
- Preterm infants, Oxidative stress, Parenteral nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura University Children HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 29 Feb 2016 (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.
Urinary peroxides and plasma glutathione/glutathione disulfide (GSH/GSSG) ratio will be measured in preterm infants less than 32 weeks gestation before and 7 days after receiving either Light-protected (Group 1) or Light-exposed (Group 2) Total Parenteral Nutrition (TPN) solutions.
Detailed description
This study will be a prospective single blinded randomized control trial.
Inborn preterm infant less than 32 wks gestational age, receiving TPN in neonatal intensive care unit (NICU) of Mansoura University Children's Hospital as a part of their care will be included.
Preterm infant will be randomly divided into 2group:- Group 1 includes preterm infant who will receive their TPN through bags and tubing system that are protected from light by aluminum foil.
Group 2 includes preterm infant who will receive their TPN through bags and tubing system that are exposed to light.
Randomization will be done using random table technique with opaque sealed envelopes containing the serial number and the group to which the subject will be enrolled.
These envelopes will be kept in the unit ready for use at any time; each one has a number which is the serial number of the baby and group of TPN to which the baby will be enrolled.
The urine sample will be sent to the laboratory with this serial number with no information about the group of study to which this sample follows for peroxide level as well as blood sample for GSH\GSSG.
Two blood samples and two urine samples will be collected. The first one will be at 0 hour before starting TPN regimen as a base line and the second will be at 7 days of starting TPN regimen. Blood sample will be at least 1cc of blood for GSH/GSSG assay. Urine collection bag will be placed on the infant to obtain minimum of 1cc of urine for urinary peroxide level assay.
Other secondary outcomes will be assessed with duration of NICU admission including death and /or bronchopulmonary dysplasia in preterm infant at time of hospital discharge, necrotizing enterocolitis (NEC), sepsis with positive blood cultures, length of hospital stay, retinopathy of prematurity (ROP), time to full enteral feeding, duration of respiratory support, liver function, cholestasis defined as an elevated serum conjugated bilirubin >2 mg/dL, and metabolic response.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light-protection | Active comparator | Other: Light-protection of TPN solutionsLight-protection of TPN solutions. TPN bags and infusion sets will be protected from light by aluminum foils throughout the study period. |
| Light-exposure | Active comparator | Other: Light-protection of TPN solutionsTPN bags and infusion sets will be exposed to light throughout the study period. |
Who may qualify
- Ages
- 24 hours to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infant less than 32 weeks gestational age
Key exclusion criteria (2 listed)
- Infant with major congenital anomalies
- Infant of diabetic or hypertensive mother
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 |
|---|---|---|
| Light-protection of TPN solutionsTPN bags and infusion sets in the Light-protected group will be covered by aluminum foils to protect the inside TPN solution from exposure to ambient or photo-therapy lights in the NICU. Protection will be made throughout the study period until the infant reaches full feeding and TPN is discontinued. | Other | Light-exposure, Light-protection |
Primary outcome
Oxidant-antioxidant state
Time frame: 7 days
Measurement of urinary peroxides and serum GSH/GSSG ratio
9 secondary outcomes
Death and/or Bronchopulmonary dysplasia
Time frame: 60 days
Necrotizing enterocolitis as Bell's stage 2 or more
Time frame: 60 days
Sepsis
Time frame: 60 dyas
Retinopathy of prematurity pre-threshold and threshold stages
Time frame: 60 dyas
Time to full feeding
Time frame: 30 days
Duration of respiratory support
Time frame: 60 days
Neonatal cholestasis
Time frame: 60 days
Metabolic disturbance
Time frame: 60 days
Length of hospital stay
Time frame: 60 days
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 26 Jan 2018.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light-protection of TPN solutions in people with Oxidative Stress in Preterm Infants, run by Mansoura University Children Hospital at 1 site in Egypt.
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 1 inclusion and 2 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 26 Jan 2018. 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 Egypt. 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?
Oxidant-antioxidant state (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2018.