Neonatal JaundicePhase 3NCT06227624
Role of Oral Zinc in Reducing Neonatal Indirect Hyperbilirubinemia
A Phase 3 study testing Oral zinc sulfate and standard phototherapy in people with Neonatal Jaundice, run by National Liver Institute, Egypt at 1 site in Egypt.
Trial summary
This study aimed to determine the role of oral zinc in reducing the neonatal indirect hyperbilirubinemia if used concomitant with the standard phototherapy Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- Oral zinc sulfate and standard phototherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 1 Jan 2020
- Phase
- Phase 3
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with total serum bilirubin (TSB) exceeding the 40th percentile track for age as per the hour-specific bilirubin nomogram of the American Academy of Pediatrics (AAP)
- Neonates who have indirect hyperbilirubinemia, not indicated for exchange transfusion.
Who cannot join
- Neonates submitted to blood transfusion.
- Neonates indicated for exchange transfusion
- Associated congenital anomalies.
- Co-morbidities such as sepsis, pneumonia or respiratory distress.
- Neonates whom their mothers received phenobarbitone during the third trimester
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concomitant Oral Zinc Sulfate and Phototherapy Versus Phototherapy Alone in Treatment of Neonatal Indirect Hyperbilirubinemia
This study aimed to determine the role of oral zinc in reducing the neonatal indirect hyperbilirubinemia if used concomitant with the standard phototherapy
Read the detailed description
Unconjugated hyperbilirubinemia is one of the most common conditions in neonates. Although conventional treatment, phototherapy and/or exchange transfusion, is effective, both modalities are associated with several side effects. High levels of unconjugated hyperbilirubinemia causing direct serious brain injury, in the form of acute bilirubin encephalopathy which may progress to kernicterus (chronic bilirubin encephalopathy) with classically characterized permanently extrapyramidal movement disorders of dystonia, choreoathetosis or both, hearing loss due to auditory neuropathy spectrum, and oculomotor pareses. Treatment of unconjugated hyperbilirubinemia, such as phototherapy and blood exchange transfusion, is costly, takes a long time and can be dangerous. Phototherapy usage may associate with watery diarrhea, low serum calcium, retinal damage, skin rash, dehydration, and DNA mutation. Exchange transfusion can cause electrolyte imbalance, cardiac overload, air embolism, thrombophlebitis, thrombocytopenia, sepsis, necrotizing enterocolitis, transmission of blood-borne diseases, and portal vein thrombosis. These harmful adverse effects indicate the need to develop alternative therapeutic pharmacological strategies which aim to decrease the plasma concentration of unconjugated bilirubin by inhibiting production, stimulating hepatic clearance, or interrupting the enterohepatic circulation (EHC) of bilirubin. Studies have indicated that feeding inadequacy promotes EHC which is an important predictor for neonatal hyperbilirubinemia. Therefore, interruption of EHC is a potentially effective intervention. Various substances have been used to bind the bilirubin in intestinal lumen to prevent its absorption and disrupt enterohepatic circulation. These substances are such as oral agar, orlistat, active charcoal, cholestyramine, calcium phosphate or glucoronidase inhibitor like hydrolyzed casein; although the obtained results have been inconsistent.
Zinc is one of the critical trace elements which have a vital role in a wide range of biological activities in living organisms. Mendez-Sanchez et al., 2001 study was the first one which reported that zinc salts at physiological fluid media can be flocculated and almost completely adsorb unconjugated bilirubin from unsaturated micellar bile salt solutions. Vitek et al., 2005 studied the effect of zinc salts ingestion in hyperbilirubinemic rats and reported that oral zinc salts can decrease serum bilirubin levels efficiently, due to the probable enterohepatic circulation inhibition of bilirubin. Méndez-Sánchez et al., 2022 showed that administration of oral zinc sulphate can significantly decrease serum indirect bilirubin levels in adult patients with Gilbert´s syndrome.
Therefore, the anticipated role of zinc supplementation in neonatal jaundice seems to be an attractive issue for research. This study aimed to determine the role of oral zinc on treatment of neonates suffering from unconjugated hyperbilirubinemia with variable gestational ages, different levels of jaundice severity and different birth weight.
- Conditions
- Neonatal Jaundice
- Being tested
- Oral zinc sulfate and standard phototherapy
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral zinc sulfate and standard phototherapyDrug
Also called standard phototherapy alone
study the role of oral zinc sulfate in reducing level of indirect hyperbilirubinemia in neonates if used with standard phototherapy
| Study group | Role | What they receive |
|---|---|---|
| combined oral zinc salts with phototherapy | Other | neonates received combination therapy which is phototherapy and oral zinc sulfate in a dose of 5 mg every 12 hours using a calibrated dropper provided with the bottle, during the period of NICU admission of neonates on phototherapy Receives: Drug: Oral zinc sulfate and standard phototherapy |
| phototherapy group | No intervention | neonates receiving phototherapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the role of oral zinc in reducing level of unconjugated hyperbilirubinemia
Measurement of serum bilirubin after receiving zinc/ phototherapy and phototherapy alone
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Jun 2018
- Primary completion1 Jun 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal JaundiceStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized clinical trial was carried out on 192 neonates with indirect hyperbilirubinemia, at neonatal intensive care unit (NICU) of Pediatric Department, National Liver Institute (NLI), Menoufia University from (June 2018- June 2019). Research Ethics Committee of NLI approved the study, NLI- Institutional Review Board (IRB) protocol number is (00136/2018). Neonates enrolled in the study were randomly assigned into two groups. Group (1) (zinc and phototherapy group) included 95 neonates receiving phototherapy and oral zinc sulfate with a dose of 5 mg every 12 hours using a calibrated dropper provided with the bottle, during the period of NICU admission on phototherapy. Group (2) (phototherapy group) included 97 neonates receiving phototherapy alone. Both groups receiving phototherapy based on the guidelines of American Academy of Pediatrics for the treatment of neonatal indirect hyperbilirubinemia. Any adverse effect were noted and recorded.
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Liver Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samira Abdel Wahab, National Liver Institute, Egypt
- Investigators
- Heba S. Sallam, specialist, Principal investigator, Al-Dalangat Central Hospital, Beheira, EgyptHala H. Elsaeed, professor, Study chair, National liver institute. Menoufia university, EgyptMohsen H Hussein, professor, Study chair, National liver institute. Menoufia university, EgyptHanaa A. El- Alraby, Study director, National liver institute. Menoufia university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227624
- Sponsor's protocol ID
- 00136/2018
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: tabulated data in results of full perinatal and maternal history including maternal age, parity, and presence of jaundice in previous sibling were collected for all neonates. Routine general and systemic examination, laboratory investigations including complete blood count, reticulocytic count, C-reactive protein, ABO blood grouping and Rh type for neonates and their mothers and neonatal serum zinc level on admission to NICU were done. Measurement of TSB and DSB were done on admission and serially according to case severity and response to treatment, until discharge then after 24 and 72 hours after stoppage of phototherapy to detect rebound hyperbilirubinemia.
Publications
• Kumar A, Bagri NK, Basu S, Asthana RK. Zinc Supplementation for Neonatal Hyperbilirubinemia: A Randomized Controlled Trial. Indian Pediatrics . 2014; 51:375-378. • Watchko JF, Tiribelli C. Bilirubin-Induced Neurologic Damage- Mechanisms and Management Approaches. New England Journal of Medicine. 2013; 369:2021-2030. • Olusanya B O, Imam Z O, Emokpae A A, Iskander IF. Revisiting the criteria for exchange transfusion for severe neonatal hyperbilirubinemia in resource-limited settings. Neonatology. 2016; 109:97-104. • Cuperus F, Hafkamp A, Hulzebos C, Verkade H. Pharmacological therapies for unconjugated hyperbilirubinemia. Current pharmaceutical design. 2009; 15:2927-2938. • Prashanth GP. The Significance of Enterohepatic Circulation in the Causation Neonatal Hyperbilirubinemia. The Indian Journal of Pediatrics. 2012; 79:1251-1252. • Patil R, Sontakke T, Biradar A, Nalage D. Zinc: an essential trace element for human health and beyond. Food and Health. 2023; 5(3):13.
• Méndez-Sánchez N, Roldán-Valadez E, Flores M A, Cárdenas-Vázquez R, Uribe M. Zinc salts precipitate unconjugated bilirubin in vitro and inhibit enterohepatic cycling of bilirubin in hamsters. Eur J Clin Invest. 2001; 31(9):773-80. • Vitek L, Muchova L, Zelenka J, et al. The effect of zinc salts on serum bilirubin levels in hyperbilirubinemic rats. J Pediatr Gastroenterol Nutr. 2005; 40:135-140. • Méndez-Sánchez N, Martínez M, González V, Roldán-Valadez E, Flores M A Uribe M. Zinc sulfate inhibits the enterohepatic cycling of unconjugated bilirubin in subjects with Gilbert's syndrome. Annals of hepatology. 2022; 1(1): 40-43 • Bhutani VK, Johnson L, Sivieri EM. Predictive Ability of a Predischarge Hour-specific Serum Bilirubin for Subsequent Significant Hyperbilirubinemia in Healthy Term and Near-term Newborns. Pediatrics. 1999; 103:6-14.
• Duryea EL, Hawkins JS, McIntire DD, Casey BM, Leveno KJ. A Revised Birth Weight Reference for the United States. Obstetrics & Gynecology. 2014; 124. • Rasul CH, Hasan MA, Yasmin F. Outcome of neonatal hyperbilirubinemia in a tertiary care hospital in bangladesh. The Malaysian journal of medical sciences: MJMS. 2010; 17:40-44. • Johnsen Ø, Eliasson R. Evaluation of a commercially available kit for the colorimetric determination of zinc in human seminal plasma. International Journal of Andrology. 1987; 10:435-440. • Rana N, Mishra S, Bhatnagar S, Paul V, Deorari AK, Agarwal R. Efficacy of Zinc in Reducing Hyperbilirubinemia among At-Risk Neonates: A Randomized, Double-Blind, Placebo-Controlled Trial. The Indian Journal of Pediatrics. 2011; 78:1073-1078. • Patton P, Rachmadi D, Sukadi A. Effect of oral zinc on hyperbilirubinemia in full term neonates. Paediatrica Indonesiana. 2011; 51:107-10. • Faal G, Masjedi HK, Sharifzadeh G, Kiani Z. Efficacy of zinc sulfate on indirect hyperbilirubinemia in premature infants admitted to neonatal intensive care unit: a double-blind, randomized clinical trial. BMC pediatrics. 2020; 20:1-7.
• Mandlecha TH, Mundada SM, Gire PK, Reddy N, Khaire P, Joshi T, Pawar S. Effect of Oral Zinc Supplementation on Serum Bilirubin Levels in Term Neonates With Hyperbilirubinemia Undergoing Phototherapy: A Double-blind Randomized Controlled Trial. Indian Pediatrics. 2023; 60:991-995. • Elfarargy MS, Al-Ashmawy MG, Abu-Risha SE, Khattab H. Zinc Supplementation in Preterm Neonates with Jaundice: Is it Beneficial?. Endocr Metab Immune Disord Drug Targets. 2021; 21(10):1929-1934. • Mafinezhad S, Bayani G, Bozorgnia Y, Khodaparast M, Jodat S. Effect of oral zinc sulfate on reducing hyperbilirubinemia among newborns under 1800 gram. Journal of North Khorasan University of Medical Sciences. 2016; 7:897-904. • Indrio F, Baldassarre ME, Francavilla R. Will Hyperbilirubinemic Neonates Ever Benefit from Oral Zinc Salt?. Journal of Pediatric Gastroenterology and Nutrition. 2006; 42:118-119.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Oral Zinc Sulfate and Phototherapy Versus Phototherapy Alone in Treatment of Neonatal Indirect Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT06227624
- Acronym / sponsor ID
- 00136/2018
- Conditions
- Neonatal Jaundice
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- National Liver Institute, EgyptUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 29 Jan 2024 (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.
This study aimed to determine the role of oral zinc in reducing the neonatal indirect hyperbilirubinemia if used concomitant with the standard phototherapy
Detailed description
Unconjugated hyperbilirubinemia is one of the most common conditions in neonates. Although conventional treatment, phototherapy and/or exchange transfusion, is effective, both modalities are associated with several side effects. High levels of unconjugated hyperbilirubinemia causing direct serious brain injury, in the form of acute bilirubin encephalopathy which may progress to kernicterus (chronic bilirubin encephalopathy) with classically characterized permanently extrapyramidal movement disorders of dystonia, choreoathetosis or both, hearing loss due to auditory neuropathy spectrum, and oculomotor pareses. Treatment of unconjugated hyperbilirubinemia, such as phototherapy and blood exchange transfusion, is costly, takes a long time and can be dangerous. Phototherapy usage may associate with watery diarrhea, low serum calcium, retinal damage, skin rash, dehydration, and DNA mutation. Exchange transfusion can cause electrolyte imbalance, cardiac overload, air embolism, thrombophlebitis, thrombocytopenia, sepsis, necrotizing enterocolitis, transmission of blood-borne diseases, and portal vein thrombosis. These harmful adverse effects indicate the need to develop alternative therapeutic pharmacological strategies which aim to decrease the plasma concentration of unconjugated bilirubin by inhibiting production, stimulating hepatic clearance, or interrupting the enterohepatic circulation (EHC) of bilirubin. Studies have indicated that feeding inadequacy promotes EHC which is an important predictor for neonatal hyperbilirubinemia. Therefore, interruption of EHC is a potentially effective intervention. Various substances have been used to bind the bilirubin in intestinal lumen to prevent its absorption and disrupt enterohepatic circulation. These substances are such as oral agar, orlistat, active charcoal, cholestyramine, calcium phosphate or glucoronidase inhibitor like hydrolyzed casein; although the obtained results have been inconsistent.
Zinc is one of the critical trace elements which have a vital role in a wide range of biological activities in living organisms. Mendez-Sanchez et al., 2001 study was the first one which reported that zinc salts at physiological fluid media can be flocculated and almost completely adsorb unconjugated bilirubin from unsaturated micellar bile salt solutions. Vitek et al., 2005 studied the effect of zinc salts ingestion in hyperbilirubinemic rats and reported that oral zinc salts can decrease serum bilirubin levels efficiently, due to the probable enterohepatic circulation inhibition of bilirubin. Méndez-Sánchez et al., 2022 showed that administration of oral zinc sulphate can significantly decrease serum indirect bilirubin levels in adult patients with Gilbert´s syndrome.
Therefore, the anticipated role of zinc supplementation in neonatal jaundice seems to be an attractive issue for research. This study aimed to determine the role of oral zinc on treatment of neonates suffering from unconjugated hyperbilirubinemia with variable gestational ages, different levels of jaundice severity and different birth weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized clinical trial was carried out on 192 neonates with indirect hyperbilirubinemia, at neonatal intensive care unit (NICU) of Pediatric Department, National Liver Institute (NLI), Menoufia University from (June 2018- June 2019). Research Ethics Committee of NLI approved the study, NLI- Institutional Review Board (IRB) protocol number is (00136/2018). Neonates enrolled in the study were randomly assigned into two groups. Group (1) (zinc and phototherapy group) included 95 neonates receiving phototherapy and oral zinc sulfate with a dose of 5 mg every 12 hours using a calibrated dropper provided with the bottle, during the period of NICU admission on phototherapy. Group (2) (phototherapy group) included 97 neonates receiving phototherapy alone. Both groups receiving phototherapy based on the guidelines of American Academy of Pediatrics for the treatment of neonatal indirect hyperbilirubinemia. Any adverse effect were noted and recorded.
| Arm | Type | Receives |
|---|---|---|
| combined oral zinc salts with phototherapy | Other | Drug: Oral zinc sulfate and standard phototherapyneonates received combination therapy which is phototherapy and oral zinc sulfate in a dose of 5 mg every 12 hours using a calibrated dropper provided with the bottle, during the period of NICU admission of neonates on phototherapy |
| phototherapy group | No intervention | –neonates receiving phototherapy alone |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Neonates with total serum bilirubin (TSB) exceeding the 40th percentile track for age as per the hour-specific bilirubin nomogram of the American Academy of Pediatrics (AAP)
- Neonates who have indirect hyperbilirubinemia, not indicated for exchange transfusion.
Key exclusion criteria (5 listed)
- Neonates submitted to blood transfusion.
- Neonates indicated for exchange transfusion
- Associated congenital anomalies.
- Co-morbidities such as sepsis, pneumonia or respiratory distress.
- Neonates whom their mothers received phenobarbitone during the third trimester
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 |
|---|---|---|
| Oral zinc sulfate and standard phototherapyAlso: standard phototherapy alonestudy the role of oral zinc sulfate in reducing level of indirect hyperbilirubinemia in neonates if used with standard phototherapy | Drug | combined oral zinc salts with phototherapy |
Primary outcome
Determine the role of oral zinc in reducing level of unconjugated hyperbilirubinemia
Time frame: Baseline
Measurement of serum bilirubin after receiving zinc/ phototherapy and phototherapy alone
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 29 Jan 2024.
- Background• Kumar A, Bagri NK, Basu S, Asthana RK. Zinc Supplementation for Neonatal Hyperbilirubinemia: A Randomized Controlled Trial. Indian Pediatrics . 2014; 51:375-378. • Watchko JF, Tiribelli C. Bilirubin-Induced Neurologic Damage- Mechanisms and Management Approaches. New England Journal of Medicine. 2013; 369:2021-2030. • Olusanya B O, Imam Z O, Emokpae A A, Iskander IF. Revisiting the criteria for exchange transfusion for severe neonatal hyperbilirubinemia in resource-limited settings. Neonatology. 2016; 109:97-104. • Cuperus F, Hafkamp A, Hulzebos C, Verkade H. Pharmacological therapies for unconjugated hyperbilirubinemia. Current pharmaceutical design. 2009; 15:2927-2938. • Prashanth GP. The Significance of Enterohepatic Circulation in the Causation Neonatal Hyperbilirubinemia. The Indian Journal of Pediatrics. 2012; 79:1251-1252. • Patil R, Sontakke T, Biradar A, Nalage D. Zinc: an essential trace element for human health and beyond. Food and Health. 2023; 5(3):13.
- Background• Méndez-Sánchez N, Roldán-Valadez E, Flores M A, Cárdenas-Vázquez R, Uribe M. Zinc salts precipitate unconjugated bilirubin in vitro and inhibit enterohepatic cycling of bilirubin in hamsters. Eur J Clin Invest. 2001; 31(9):773-80. • Vitek L, Muchova L, Zelenka J, et al. The effect of zinc salts on serum bilirubin levels in hyperbilirubinemic rats. J Pediatr Gastroenterol Nutr. 2005; 40:135-140. • Méndez-Sánchez N, Martínez M, González V, Roldán-Valadez E, Flores M A Uribe M. Zinc sulfate inhibits the enterohepatic cycling of unconjugated bilirubin in subjects with Gilbert's syndrome. Annals of hepatology. 2022; 1(1): 40-43 • Bhutani VK, Johnson L, Sivieri EM. Predictive Ability of a Predischarge Hour-specific Serum Bilirubin for Subsequent Significant Hyperbilirubinemia in Healthy Term and Near-term Newborns. Pediatrics. 1999; 103:6-14.
- Background• Duryea EL, Hawkins JS, McIntire DD, Casey BM, Leveno KJ. A Revised Birth Weight Reference for the United States. Obstetrics & Gynecology. 2014; 124. • Rasul CH, Hasan MA, Yasmin F. Outcome of neonatal hyperbilirubinemia in a tertiary care hospital in bangladesh. The Malaysian journal of medical sciences: MJMS. 2010; 17:40-44. • Johnsen Ø, Eliasson R. Evaluation of a commercially available kit for the colorimetric determination of zinc in human seminal plasma. International Journal of Andrology. 1987; 10:435-440. • Rana N, Mishra S, Bhatnagar S, Paul V, Deorari AK, Agarwal R. Efficacy of Zinc in Reducing Hyperbilirubinemia among At-Risk Neonates: A Randomized, Double-Blind, Placebo-Controlled Trial. The Indian Journal of Pediatrics. 2011; 78:1073-1078. • Patton P, Rachmadi D, Sukadi A. Effect of oral zinc on hyperbilirubinemia in full term neonates. Paediatrica Indonesiana. 2011; 51:107-10. • Faal G, Masjedi HK, Sharifzadeh G, Kiani Z. Efficacy of zinc sulfate on indirect hyperbilirubinemia in premature infants admitted to neonatal intensive care unit: a double-blind, randomized clinical trial. BMC pediatrics. 2020; 20:1-7.
- Background• Mandlecha TH, Mundada SM, Gire PK, Reddy N, Khaire P, Joshi T, Pawar S. Effect of Oral Zinc Supplementation on Serum Bilirubin Levels in Term Neonates With Hyperbilirubinemia Undergoing Phototherapy: A Double-blind Randomized Controlled Trial. Indian Pediatrics. 2023; 60:991-995. • Elfarargy MS, Al-Ashmawy MG, Abu-Risha SE, Khattab H. Zinc Supplementation in Preterm Neonates with Jaundice: Is it Beneficial?. Endocr Metab Immune Disord Drug Targets. 2021; 21(10):1929-1934. • Mafinezhad S, Bayani G, Bozorgnia Y, Khodaparast M, Jodat S. Effect of oral zinc sulfate on reducing hyperbilirubinemia among newborns under 1800 gram. Journal of North Khorasan University of Medical Sciences. 2016; 7:897-904. • Indrio F, Baldassarre ME, Francavilla R. Will Hyperbilirubinemic Neonates Ever Benefit from Oral Zinc Salt?. Journal of Pediatric Gastroenterology and Nutrition. 2006; 42:118-119.
- Individual participant dataSharing planned: Yes. tabulated data in results of full perinatal and maternal history including maternal age, parity, and presence of jaundice in previous sibling were collected for all neonates. Routine general and systemic examination, laboratory investigations including complete blood count, reticulocytic count, C-reactive protein, ABO blood grouping and Rh type for neonates and their mothers and neonatal serum zinc level on admission to NICU were done. Measurement of TSB and DSB were done on admission and serially according to case severity and response to treatment, until discharge then after 24 and 72 hours after stoppage of phototherapy to detect rebound hyperbilirubinemia.
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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.
Heba S. Sallam, specialist principal investigator
Al-Dalangat Central Hospital, Beheira, Egypt
Hala H. Elsaeed, professor study chair
National liver institute. Menoufia university, Egypt
Mohsen H Hussein, professor study chair
National liver institute. Menoufia university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral zinc sulfate and standard phototherapy in people with Neonatal Jaundice, run by National Liver Institute, Egypt 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 2 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 29 Jan 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Determine the role of oral zinc in reducing level of unconjugated hyperbilirubinemia (time frame: Baseline). 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 NCT06227624, which also lists 4 linked publications.
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 29 Jan 2024.