Oxidative StressNCT03074292
Comparison Between Effect of Conventional, Intensive and Light Emitting Diodes (LED) Phototherapy on Oxidative Stress Among Neonates With Unconjugated Hyperbilirubinemia
A study testing phototherapy in people with Oxidative Stress and Neonatal Hyperbilirubinemia, run by Rania Ali El-Farrash.
Trial summary
The aim of the present study is to test a hypothesis assuming that phototherapy might have an effect on oxidant/antioxidant status in term and late-preterm neonates with unconjugated hyperbilirubinemia. Read more about this study
- Who is it for?
- Ages 2 to 28 days
- Conditions the study is for
- Oxidative Stress, Neonatal Hyperbilirubinemia, Phototherapy Complication
- What is being tested?
- phototherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Mar 2017
- 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 2 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term and late-preterm neonates (≥35weeks) according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns were determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present.
- Clinical significant indirect hyperbilirubinemia requiring phototherapy in the first week of life.
- Normal blood counts and peripheral blood smears
- Normal reticulocytic count.
- Breast fed newborn.
Who cannot join
- Those in whom the total serum bilirubin (TSB) level rose by more than 5 mg/dl per day or was higher than 20 mg/dl within the first 24 hours after birth were excluded from the study.
- Infant of diabetic mothers.
- Maternal eclampsia-preeclampsia.
- Birth asphyxia
- Sepsis
- congenital anomalies.
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- Direct Coombs'test positive
- Pathological causes of hyperbilirubinemia.
- Enclosed hemorrhage.
- Hemolytic type of hyperbilirubinemia due to blood group or Rh incompatibility.
About this study
The aim of the present study is to test a hypothesis assuming that phototherapy might have an effect on oxidant/antioxidant status in term and late-preterm neonates with unconjugated hyperbilirubinemia.
- Being tested
- phototherapy
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phototherapyProcedure or surgery
estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy
| Study group | Role | What they receive |
|---|---|---|
| conventional phototherapy | Active comparator | neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy Receives: Procedure: phototherapy |
| extensive phototherapy | Active comparator | neonates with unconjugated hyperbilirubinemia exposed to extensive phototherapy Receives: Procedure: phototherapy |
| LED phototherapy | Active comparator | neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy Receives: Procedure: phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of types of phototherapy on change in total antioxidant capacity (TAC)
This will be determined by:
- Measure TAC (mmol/L) before and after phototherapy
- Compare results of TAC (mmol/L) before and after phototherapy.
Measured: 2 days
Effect of types of phototherapy on change in malonaldehyde (MDA)
This will be determined by:
- Measure MDA (nmol/L) before and after phototherapy
- Compare results of MDA (nmol/L) before and after phototherapy.
Measured: 2 days
Effect of types of phototherapy on change in nitric oxide (NO)
This will be determined by:
- Measure NO (umol/L) before and after phototherapy
- Compare results of NO (umol/L) before and after phototherapy.
Measured: 2 days
Secondary outcomes (4)
Effect of types of phototherapy on change in serum iron (Fe)
This will be determined by:
- Measure serum Fe before and after phototherapy
- Compare results of serum Fe before and after phototherapy.
Measured: 2 days
Effect of types of phototherapy on change in serum copper (Cu)
This will be determined by:
- Measure serum Cu before and after phototherapy
- Compare results of serum Cu before and after phototherapy.
Measured: 2 days
Effect of types of phototherapy on change in serum zinc (Zn)
This will be determined by:
- Measure serum Zn before and after phototherapy
- Compare results of serum Zn before and after phototherapy.
Measured: 2 days
Effect of types of phototherapy on change in serum calcium (Zn)
This will be determined by:
- Measure serum Ca before and after phototherapy
- Compare results of serum Ca before and after phototherapy.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study startDec 2013
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
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 Oxidative StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rania Ali El-Farrash
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rania Ali El-Farrash, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074292
- Sponsor's protocol ID
- 00006444
- Status last verified
- Mar 2017
- First submitted
- 16 Feb 2017
- Last updated
- 8 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El-Farrash RA, El-Shimy MS, Tawfik S, Nada AS, Salem DAD, M Gallo MS, Abd-Elmohsen EW. Effect of phototherapy on oxidant/antioxidant status: a randomized controlled trial. Free Radic Res. 2019 Feb;53(2):179-186. doi: 10.1080/10715762.2018.1549364. Epub 2019 Mar 1.
PubMed 30458636
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Effect of Conventional, Intensive and Light Emitting Diodes (LED) Phototherapy on Oxidative Stress Among Neonates With Unconjugated Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT03074292
- Acronym / sponsor ID
- 00006444
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rania Ali El-FarrashUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 8 Mar 2017 (actual)
- 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 aim of the present study is to test a hypothesis assuming that phototherapy might have an effect on oxidant/antioxidant status in term and late-preterm neonates with unconjugated hyperbilirubinemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional phototherapy | Active comparator | Procedure: phototherapyneonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy |
| extensive phototherapy | Active comparator | Procedure: phototherapyneonates with unconjugated hyperbilirubinemia exposed to extensive phototherapy |
| LED phototherapy | Active comparator | Procedure: phototherapyneonates with unconjugated hyperbilirubinemia exposed to LED phototherapy |
Who may qualify
- Ages
- 2 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Term and late-preterm neonates (≥35weeks) according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns were determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present.
- Clinical significant indirect hyperbilirubinemia requiring phototherapy in the first week of life.
- Normal blood counts and peripheral blood smears
- Normal reticulocytic count.
- Breast fed newborn.
Key exclusion criteria (10 listed)
- Those in whom the total serum bilirubin (TSB) level rose by more than 5 mg/dl per day or was higher than 20 mg/dl within the first 24 hours after birth were excluded from the study.
- Infant of diabetic mothers.
- Maternal eclampsia-preeclampsia.
- Birth asphyxia
- Sepsis
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 |
|---|---|---|
| phototherapyestimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy | Procedure or surgery | LED phototherapy, conventional phototherapy, extensive phototherapy |
Primary outcome
Effect of types of phototherapy on change in total antioxidant capacity (TAC)
Time frame: 2 days
This will be determined by: 1. Measure TAC (mmol/L) before and after phototherapy 2. Compare results of TAC (mmol/L) before and after phototherapy.
Effect of types of phototherapy on change in malonaldehyde (MDA)
Time frame: 2 days
This will be determined by: 1. Measure MDA (nmol/L) before and after phototherapy 2. Compare results of MDA (nmol/L) before and after phototherapy.
Effect of types of phototherapy on change in nitric oxide (NO)
Time frame: 2 days
This will be determined by: 1. Measure NO (umol/L) before and after phototherapy 2. Compare results of NO (umol/L) before and after phototherapy.
4 secondary outcomes
Effect of types of phototherapy on change in serum iron (Fe)
Time frame: 2 days
Effect of types of phototherapy on change in serum copper (Cu)
Time frame: 2 days
Effect of types of phototherapy on change in serum zinc (Zn)
Time frame: 2 days
Effect of types of phototherapy on change in serum calcium (Zn)
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Derived from this study: PubMed 30458636El-Farrash RA, El-Shimy MS, Tawfik S, Nada AS, Salem DAD, M Gallo MS, Abd-Elmohsen EW. Effect of phototherapy on oxidant/antioxidant status: a randomized controlled trial. Free Radic Res. 2019 Feb;53(2):179-186. doi: 10.1080/10715762.2018.1549364. Epub 2019 Mar 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing phototherapy in people with Oxidative Stress and Neonatal Hyperbilirubinemia, run by Rania Ali El-Farrash.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 8 Mar 2017. 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. 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?
Results are not available in the source record.
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?
Effect of types of phototherapy on change in total antioxidant capacity (TAC) (time frame: 2 days). The study lists 3 primary outcomes in all. 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 NCT03074292, 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 8 Mar 2017.