Preterm Neonate AnalgesiaPhase 2NCT05971485
Melatonin As an Analgesic in Preterm Neonate
A Phase 2 study testing Melatonin 10 mg in people with Preterm Neonate Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with several important functions, including regulation of the circadian rhythms, antioxidant and anti-inflammatory effects, accumulating evidence revealed that it also plays an important role in pain modulation through multiple… Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Preterm Neonate Analgesia
- What is being tested?
- Melatonin 10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2022to 30 Oct 2024
- Phase
- Phase 2
- 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
- No healthy volunteers
- Child
Who may be able to join
- Preterm infant
- less than 37 weeks gestational age
- who started enteral feeding.
Who cannot join
- Multiple congenital anomalies.
- Facial malformation.
- Receiving analgesia or sedation.
- Contraindication of enteral feeding.
- Clinical or laboratory signs of sepsis.
- Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Melatonin As an Analgesic in Preterm Neonate
Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with several important functions, including regulation of the circadian rhythms, antioxidant and anti-inflammatory effects, accumulating evidence revealed that it also plays an important role in pain modulation through multiple mechanisms. The investigators aimed to evaluate the analgesic effect of enteral melatonin given 30 minutes before cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure. Additionally, the study aimed to explore the relationship between procedural pain and oxidative stress, along with the effectiveness of pain management of melatonin by measuring Malondialdehyde (MDA), a well-accepted marker of oxidative stress, 60 minutes after the procedure.
Read the detailed description
This is a randomized, double-blind, controlled trial
- Conditions
- Preterm Neonate Analgesia
- Being tested
- Melatonin 10 mg, Placebo
- Keywords
- Preterm, Analgesia, Melatonin, Oxidative stress
- Medical subject headings
- Premature Birth, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 10 mgDrug
Melatonin 10 mg will be used. 5 mg·kg-1 dissolved in 2 ml of distilled water via enteral route in one single dose 30 minutes before the venous cannula insertion
PlaceboOther
The placebo group will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin group | Experimental | Preterm neonates will receive melatonin 30 minutes before the venous cannula insertion. Receives: Drug: Melatonin 10 mg |
| Placebo group | Placebo comparator | Preterm neonates will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the analgesic effect of melatonin in preterm
Evaluate the analgesic effect of melatonin during venous cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure.
Premature Infant pain Profile score (PIPP) scale 0-21, with 0-6 reflecting no pain, 6-12 reflecting mild-moderate pain, and above 12 indicating severe pain
Measured: 5 minutes starting just before cannula insertion to 5 minutes after the procedure
Malondialdehyde (MDA), marker of oxidative stress
Serum Malondialdehyde (MDA), a marker of oxidative stress through measuring serum MDA after 60 minutes of the procedure
Measured: 60 minutes of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start20 Aug 2022
- Primary completion30 Sep 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Neonate AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971485
- Sponsor's protocol ID
- FMASU MS 496/2022
- Status last verified
- Dec 2024
- First submitted
- 25 Jul 2023
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Melatonin As an Analgesic in Preterm Neonate
- ClinicalTrials.gov ID
- NCT05971485
- Acronym / sponsor ID
- FMASU MS 496/2022
- Conditions
- Preterm Neonate Analgesia
- Keywords
- Preterm, Analgesia, Melatonin, Oxidative stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 2 Aug 2023 (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.
Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with several important functions, including regulation of the circadian rhythms, antioxidant and anti-inflammatory effects, accumulating evidence revealed that it also plays an important role in pain modulation through multiple mechanisms. The investigators aimed to evaluate the analgesic effect of enteral melatonin given 30 minutes before cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure. Additionally, the study aimed to explore the relationship between procedural pain and oxidative stress, along with the effectiveness of pain management of melatonin by measuring Malondialdehyde (MDA), a well-accepted marker of oxidative stress, 60 minutes after the procedure.
Detailed description
This is a randomized, double-blind, controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin group | Experimental | Drug: Melatonin 10 mgPreterm neonates will receive melatonin 30 minutes before the venous cannula insertion. |
| Placebo group | Placebo comparator | Other: PlaceboPreterm neonates will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infant
- less than 37 weeks gestational age
- who started enteral feeding.
Key exclusion criteria (6 listed)
- Multiple congenital anomalies.
- Facial malformation.
- Receiving analgesia or sedation.
- Contraindication of enteral feeding.
- Clinical or laboratory signs of 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 |
|---|---|---|
| Melatonin 10 mgMelatonin 10 mg will be used. 5 mg·kg-1 dissolved in 2 ml of distilled water via enteral route in one single dose 30 minutes before the venous cannula insertion | Drug | Melatonin group |
| PlaceboThe placebo group will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion. | Other | Placebo group |
Primary outcome
Evaluate the analgesic effect of melatonin in preterm
Time frame: 5 minutes starting just before cannula insertion to 5 minutes after the procedure
Evaluate the analgesic effect of melatonin during venous cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure. Premature Infant pain Profile score (PIPP) scale 0-21, with 0-6 reflecting no pain, 6-12 reflecting mild-moderate pain, and above 12 indicating severe pain
Malondialdehyde (MDA), marker of oxidative stress
Time frame: 60 minutes of the procedure
Serum Malondialdehyde (MDA), a marker of oxidative stress through measuring serum MDA after 60 minutes of the procedure
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 Jan 2025.
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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 Phase 2 study testing Melatonin 10 mg in people with Preterm Neonate Analgesia, run by Ain Shams University 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 3 inclusion and 6 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 Jan 2025. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evaluate the analgesic effect of melatonin in preterm (time frame: 5 minutes starting just before cannula insertion to 5 minutes after the procedure). The study lists 2 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 Jan 2025.