Neonatal JaundiceNCT04433923
Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants
A study testing Phototherapy with aluminum foil and Phototherapy without aluminum foil in people with Neonatal Jaundice, run by Mansoura University.
Trial summary
prospective single center pilot randomized open label clinical trial, conducted at the Neonatal care unit of Mansoura University Children's To assess the efficacy and safety of aluminum foil use in combination with phototherapy compared with phototherapy alone for pathological unconjugated hyperbilirubinaemia in full… Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- Phototherapy with aluminum foil and Phototherapy without aluminum foil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 1 Dec 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 Up to 28 days
- All sexes
- Child
Who may be able to join
- Appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinaemia who are candidate for photo therapy according to American academy guidelines
Who cannot join
- Preterm infants, newborn infant with congenital malformations, conjugated hyperbilirubinamia, small for gestational age, in need of exchange transfusion, and skin abrasions or infections
About this study
Official title: Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants: Randomised Control Trial
prospective single center pilot randomized open label clinical trial, conducted at the Neonatal care unit of Mansoura University Children's To assess the efficacy and safety of aluminum foil use in combination with phototherapy compared with phototherapy alone for pathological unconjugated hyperbilirubinaemia in full term newborn We enrolled 234 infants in the study who fulfilled the inclusion criteria and were randomly assigned to treatment groups, either conventional phototherapy with aluminum foil or conventional phototherapy alone.
- Conditions
- Neonatal Jaundice
- Being tested
- Phototherapy with aluminum foil, Phototherapy without aluminum foil
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phototherapy with aluminum foilDevice
Phototherapy without aluminum foilDevice
| Study group | Role | What they receive |
|---|---|---|
| GROUP1 | Active comparator | Phototherapy with aluminum foil Receives: Device: Phototherapy with aluminum foil |
| GROUP2 | Placebo comparator | Phototherapy without aluminum foil Receives: Device: Phototherapy without aluminum foil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total serum bilirubin
measurement of Total serum bilirubin (mg/dl)
Measured: 8 hours of treatment
Total serum bilirubin
measurement of Total serum bilirubin (mg/dl)
Measured: 24 hours of treatment
Total serum bilirubin
measurement of Total serum bilirubin (mg/dl)
Measured: 48 hours of treatment
Secondary outcomes (1)
duration of photo therapy
duration of photo therapy in hours
Measured: average 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jun 2016
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal JaundiceStudies 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
- Treatment
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd Elazeez Attala Shabaan, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433923
- Sponsor's protocol ID
- MansouraU004
- Status last verified
- Jun 2020
- First submitted
- 13 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants: Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04433923
- Acronym / sponsor ID
- MansouraU004
- Conditions
- Neonatal Jaundice
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 16 Jun 2020 (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.
prospective single center pilot randomized open label clinical trial, conducted at the Neonatal care unit of Mansoura University Children's To assess the efficacy and safety of aluminum foil use in combination with phototherapy compared with phototherapy alone for pathological unconjugated hyperbilirubinaemia in full term newborn We enrolled 234 infants in the study who fulfilled the inclusion criteria and were randomly assigned to treatment groups, either conventional phototherapy with aluminum foil or conventional phototherapy alone.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP1 | Active comparator | Device: Phototherapy with aluminum foilPhototherapy with aluminum foil |
| GROUP2 | Placebo comparator | Device: Phototherapy without aluminum foilPhototherapy without aluminum foil |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- Appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinaemia who are candidate for photo therapy according to American academy guidelines
Key exclusion criteria (1 listed)
- Preterm infants, newborn infant with congenital malformations, conjugated hyperbilirubinamia, small for gestational age, in need of exchange transfusion, and skin abrasions or infections
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 |
|---|---|---|
| Phototherapy with aluminum foil | Device | GROUP1 |
| Phototherapy without aluminum foil | Device | GROUP2 |
Primary outcome
Total serum bilirubin
Time frame: 8 hours of treatment
measurement of Total serum bilirubin (mg/dl)
Total serum bilirubin
Time frame: 24 hours of treatment
measurement of Total serum bilirubin (mg/dl)
Total serum bilirubin
Time frame: 48 hours of treatment
measurement of Total serum bilirubin (mg/dl)
1 secondary outcome
duration of photo therapy
Time frame: average 48 hours
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 16 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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 with aluminum foil and Phototherapy without aluminum foil in people with Neonatal Jaundice, 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 1 inclusion and 1 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 16 Jun 2020. 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?
Total serum bilirubin (time frame: 8 hours of treatment). 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?
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 16 Jun 2020.