Sepsis NewbornNCT06191523
The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis
A study testing Treatment Group in people with Sepsis Newborn, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to assess the effect of melatonin on MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis. The main question aim to answer : Does melatonin affect MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis? The participants in… Read more about this study
- Who is it for?
- Ages 28 to 36 weeks
- Conditions the study is for
- Sepsis Newborn
- What is being tested?
- Treatment Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 Apr 2023to 20 Oct 2023
- 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 28 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with gestational age of 28-36+6 weeks, birth weight according to gestational age, and diagnosis of sepsis based on HPS and PRS sepsis score criteria
Who cannot join
- Major congenital anomalies of the gastrointestinal tract.
- Continuous vomiting.
- Newborns with hypoxic ischemic encephalopathy (HIE), intracranial hemorrhage, feeding intolerance, necrotizing enterocolitis (NEC) and hormonal disorders.
- Septic shock.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis (Review of Malondialdehyde, Interleukin-6, Interleukin-8, Absolute Neutrophil Counts, and Sepsis Score)
The goal of this clinical trial is to assess the effect of melatonin on MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis. The main question aim to answer :
- Does melatonin affect MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis?
The participants in the treatment group will receive a single dose of oral melatonin 20 mg, meanwhile those the control group will receive placebo.
The researchers will compare MDA serum, IL-6, IL-8 levels, ANC, and sepsis score before and after receiving melatonin, whether there are decreases of MDA serum, IL-6, IL-8 levels, ANC and increase of sepsis score
- Conditions
- Sepsis Newborn
- Being tested
- Control Group, Treatment Group
- Keywords
- melatonin, sepsis, preterm neonates
- Medical subject headings
- Neonatal Sepsis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
The control group will receive standard therapy and placebo.
Treatment GroupDrug
The participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | The control group will receive standard therapy and placebo. Receives: Other: Control Group; Drug: Treatment Group |
| Treatment Group | Experimental | The participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg Receives: Other: Control Group; Drug: Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Improvement of Sepsis Score Based on Gitto Scoring System
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start27 Apr 2023
- Primary completion5 Oct 2023
- Study completion20 Oct 2023
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 Sepsis NewbornStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dwi Hidayah, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191523
- Sponsor's protocol ID
- 1.657/XII/HREC/2022
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Henderson R, Kim S, Lee E. Use of melatonin as adjunctive therapy in neonatal sepsis: A systematic review and meta-analysis. Complement Ther Med. 2018 Aug;39:131-136. doi: 10.1016/j.ctim.2018.06.002. Epub 2018 Jun 11.
PubMed 30012383Gitto E, Karbownik M, Reiter RJ, Tan DX, Cuzzocrea S, Chiurazzi P, Cordaro S, Corona G, Trimarchi G, Barberi I. Effects of melatonin treatment in septic newborns. Pediatr Res. 2001 Dec;50(6):756-60. doi: 10.1203/00006450-200112000-00021.
PubMed 11726736El-Gendy FM, El-Hawy MA, Hassan MG. Beneficial effect of melatonin in the treatment of neonatal sepsis. J Matern Fetal Neonatal Med. 2018 Sep;31(17):2299-2303. doi: 10.1080/14767058.2017.1342794. Epub 2017 Jul 6.
PubMed 28612668El Frargy M, El-Sharkawy HM, Attia GF. Use of melatonin as an adjuvant therapy in neonatal sepsis. J Neonatal Perinatal Med. 2015;8(3):227-32. doi: 10.3233/NPM-15814072.
PubMed 26485549
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis (Review of Malondialdehyde, Interleukin-6, Interleukin-8, Absolute Neutrophil Counts, and Sepsis Score)
- ClinicalTrials.gov ID
- NCT06191523
- Acronym / sponsor ID
- 1.657/XII/HREC/2022
- Conditions
- Sepsis Newborn
- Keywords
- melatonin, sepsis, preterm neonates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 5 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.
The goal of this clinical trial is to assess the effect of melatonin on MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis. The main question aim to answer :
- Does melatonin affect MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis?
The participants in the treatment group will receive a single dose of oral melatonin 20 mg, meanwhile those the control group will receive placebo.
The researchers will compare MDA serum, IL-6, IL-8 levels, ANC, and sepsis score before and after receiving melatonin, whether there are decreases of MDA serum, IL-6, IL-8 levels, ANC and increase of sepsis score
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Control Group, Drug: Treatment GroupThe control group will receive standard therapy and placebo. |
| Treatment Group | Experimental | Other: Control Group, Drug: Treatment GroupThe participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborns with gestational age of 28-36+6 weeks, birth weight according to gestational age, and diagnosis of sepsis based on HPS and PRS sepsis score criteria
Key exclusion criteria (4 listed)
- Major congenital anomalies of the gastrointestinal tract.
- Continuous vomiting.
- Newborns with hypoxic ischemic encephalopathy (HIE), intracranial hemorrhage, feeding intolerance, necrotizing enterocolitis (NEC) and hormonal disorders.
- Septic shock.
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 |
|---|---|---|
| Control GroupThe control group will receive standard therapy and placebo. | Other | Control Group, Treatment Group |
| Treatment GroupThe participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg | Drug | Control Group, Treatment Group |
Primary outcome
Number of Participants with Treatment-Related Improvement of Sepsis Score Based on Gitto Scoring System
Time frame: From enrollment to the end of treatment at 6 months
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 5 Jan 2024.
- Results publication: PubMed 30012383Henderson R, Kim S, Lee E. Use of melatonin as adjunctive therapy in neonatal sepsis: A systematic review and meta-analysis. Complement Ther Med. 2018 Aug;39:131-136. doi: 10.1016/j.ctim.2018.06.002. Epub 2018 Jun 11.
- Results publication: PubMed 11726736Gitto E, Karbownik M, Reiter RJ, Tan DX, Cuzzocrea S, Chiurazzi P, Cordaro S, Corona G, Trimarchi G, Barberi I. Effects of melatonin treatment in septic newborns. Pediatr Res. 2001 Dec;50(6):756-60. doi: 10.1203/00006450-200112000-00021.
- Results publication: PubMed 28612668El-Gendy FM, El-Hawy MA, Hassan MG. Beneficial effect of melatonin in the treatment of neonatal sepsis. J Matern Fetal Neonatal Med. 2018 Sep;31(17):2299-2303. doi: 10.1080/14767058.2017.1342794. Epub 2017 Jul 6.
- Results publication: PubMed 26485549El Frargy M, El-Sharkawy HM, Attia GF. Use of melatonin as an adjuvant therapy in neonatal sepsis. J Neonatal Perinatal Med. 2015;8(3):227-32. doi: 10.3233/NPM-15814072.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Group in people with Sepsis Newborn, run by Universitas Sebelas Maret at 1 site in Indonesia.
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 4 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 5 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 Indonesia. 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?
Number of Participants with Treatment-Related Improvement of Sepsis Score Based on Gitto Scoring System (time frame: From enrollment to the end of treatment at 6 months). 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 NCT06191523, 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 5 Jan 2024.