Serum BilirubinNCT05161611
Effect of Oral Zinc Sulfate on Jaundice in Neonates Admitted to Neonatal Intensive Care Unit
A study testing Zinc sulfate and Phototherapy in people with Serum Bilirubin, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
A randomized double-blind clinical trial will be performed in the neonatal intensive care unit of Makassed General Hospital in Beirut, Lebanon from December 2021 till August 2022. Randomized opaque envelopes to allocate the treatment will be used. Read more about this study
- Who is it for?
- Ages 1 hour to 1 month
- Conditions the study is for
- Serum Bilirubin
- What is being tested?
- Zinc sulfate and Phototherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 17 Dec 2021to 28 Aug 2022
- 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 hour to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants (post-menstrual age ≥ 26 weeks) delivered by Cesarean section or vaginal delivery.
- Diagnosed to have hyperbilirubinemia:
- Hyperbilirubinemia is defined as:
- for term and near-term neonates (neonates less than 35 weeks' gestation): Serum Total Bilirubin (STB) level that would qualify for phototherapy requirement as described in American Academy of Pediatrics 2004's guidelines or absolute STB level L 15 mg/dL;
- for preterm neonates (< 35 weeks' gestation): STB level > 1% of body weight
Who cannot join
- Infants less than 26 weeks postmenstrual age
- Allergy to zinc sulfate
- Any reaction seen after administration of first dose of zinc sulfate.
- Any contraindication to oral medication
- Infants with a history of taking phenobarbital by their mother
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Zinc Sulfate on Jaundice in Neonates Admitted to Neonatal Intensive Care Unit: A Randomized, Double-Blind, Clinical Trial
A randomized double-blind clinical trial will be performed in the neonatal intensive care unit of Makassed General Hospital in Beirut, Lebanon from December 2021 till August 2022. Randomized opaque envelopes to allocate the treatment will be used. The study will include neonates aged between 26 and 42 gestational weeks, who require phototherapy in the neonatal intensive care unit. Patients will be randomized into two groups.Both groups will receive standard conventional phototherapy, but the intervention group will receive 10 mg per day oral zinc sulfate until discharge.
- Conditions
- Serum Bilirubin
- Being tested
- Zinc sulfate, Placebo, Phototherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc sulfateDrug
10 mg of oral zinc sulfate will be given to neonates per day
PlaceboOther
10 mg of normal saline will be given to neonates per day
PhototherapyOther
Neonates will be put under phototherapy
| Study group | Role | What they receive |
|---|---|---|
| Zinc sulfate | Experimental | Patients will receive 10mg/day zinc sulfate along with phototherapy after being diagnosed to have hyperbilirubinemia Receives: Drug: Zinc sulfate; Other: Phototherapy |
| Placebo | Placebo comparator | Patients will receive placebo in addition to phototherapy Receives: Other: Placebo; Other: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phototherapy duration
The number of days the neonates required phototherapy
Measured: Within one week
Secondary outcomes (2)
Total serum bilirubin level
Level of total serum bilirubin will be measured in neonates
Measured: Within one week
Occurrence of side effects
The incidence of side effects such as vomiting, diarrhea, or rash will be recorded
Measured: Within one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start17 Dec 2021
- Primary completion28 Aug 2022
- Study completion28 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serum BilirubinStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Rajab, Makassed General Hospital
- Investigators
- Mariam Rajab, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161611
- Sponsor's protocol ID
- 22062021
- Status last verified
- Aug 2022
- First submitted
- 6 Dec 2021
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Zinc Sulfate on Jaundice in Neonates Admitted to Neonatal Intensive Care Unit: A Randomized, Double-Blind, Clinical Trial
- ClinicalTrials.gov ID
- NCT05161611
- Acronym / sponsor ID
- 22062021
- Conditions
- Serum Bilirubin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 28 Aug 2022 (actual)
- Study completion
- 28 Aug 2022 (actual)
- First posted
- 17 Dec 2021 (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.
A randomized double-blind clinical trial will be performed in the neonatal intensive care unit of Makassed General Hospital in Beirut, Lebanon from December 2021 till August 2022. Randomized opaque envelopes to allocate the treatment will be used. The study will include neonates aged between 26 and 42 gestational weeks, who require phototherapy in the neonatal intensive care unit. Patients will be randomized into two groups.Both groups will receive standard conventional phototherapy, but the intervention group will receive 10 mg per day oral zinc sulfate until discharge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc sulfate | Experimental | Drug: Zinc sulfate, Other: PhototherapyPatients will receive 10mg/day zinc sulfate along with phototherapy after being diagnosed to have hyperbilirubinemia |
| Placebo | Placebo comparator | Other: Placebo, Other: PhototherapyPatients will receive placebo in addition to phototherapy |
Who may qualify
- Ages
- 1 hour to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants (post-menstrual age ≥ 26 weeks) delivered by Cesarean section or vaginal delivery.
- Diagnosed to have hyperbilirubinemia:
- for term and near-term neonates (neonates less than 35 weeks' gestation): Serum Total Bilirubin (STB) level that would qualify for phototherapy requirement as described in American Academy of Pediatrics 2004's guidelines or absolute STB level L 15 mg/dL;
- for preterm neonates (< 35 weeks' gestation): STB level > 1% of body weight
Key exclusion criteria (5 listed)
- Infants less than 26 weeks postmenstrual age
- Allergy to zinc sulfate
- Any reaction seen after administration of first dose of zinc sulfate.
- Any contraindication to oral medication
- Infants with a history of taking phenobarbital by their 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 |
|---|---|---|
| Zinc sulfate10 mg of oral zinc sulfate will be given to neonates per day | Drug | Zinc sulfate |
| Placebo10 mg of normal saline will be given to neonates per day | Other | Placebo |
| PhototherapyNeonates will be put under phototherapy | Other | Placebo, Zinc sulfate |
Primary outcome
Phototherapy duration
Time frame: Within one week
The number of days the neonates required phototherapy
2 secondary outcomes
Total serum bilirubin level
Time frame: Within one week
Occurrence of side effects
Time frame: Within one week
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 30 Aug 2022.
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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.
Mariam Rajab, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc sulfate and Phototherapy in people with Serum Bilirubin, run by Makassed General Hospital at 1 site in Lebanon.
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 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 30 Aug 2022. 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 Lebanon. 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. 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?
Phototherapy duration (time frame: Within one week). 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 30 Aug 2022.