MelatoninNCT07090720
Melatonin Effects on the Left Ventricular Function in Neonates With Persistent Pulmonary Hypertension
A study testing Melatonin in people with Melatonin and Left Ventricular Function, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effect of melatonin on the left ventricular function in neonates with persistent pulmonary hypertension Read more about this study
- Who is it for?
- Ages 36 weeks and older
- Conditions the study is for
- Melatonin, Left Ventricular Function, Neonates
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jan 2025
- 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 36 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neonates of ≥ 36 weeks of gestational age.
- Both sexes.
- Admitted with persistent pulmonary hypertension.
Who cannot join
- Preterm infants < 36 weeks of gestation.
- Infants with congenital heart diseases.
- Infants with dysrhythmia.
- Chromosomal abnormalities.
- Severe pathological jaundice.
- Metabolic or endocrinal disorders.
- Major congenital malformations.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the effect of melatonin on the left ventricular function in neonates with persistent pulmonary hypertension
Read the detailed description
Persistent pulmonary hypertension of the newborn (PPHN) is a potentially deadly disorder in which the circulation of the fetus is unable to adjust to the extrauterine environment. Persistently high pulmonary pressures may cause right-to-left shunting, hypoxia, and right ventricular failure.
Melatonin, a neurohormone produced by the pineal gland, offers an exceptional defense against reactive oxygen species (ROS). Infants are unable to synthesize melatonin during their first few weeks of life, which may exacerbate oxidative stress in hypoxic conditions. Additionally, Melatonin's antioxidative capabilities have been shown in neonatal pulmonary and respiratory disorders.
- Being tested
- Melatonin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Neonates were given Melatonin.
PlaceboOther
Neonates received placebo.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Neonates were given Melatonin. Receives: Drug: Melatonin |
| Group II | Placebo comparator | Neonates received placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricle global longitudinal strain
Left ventricle global longitudinal strain (LV-GLS) was recorded.
Measured: Immediately after medication (Up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Jan 2023
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelatoninStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mahmoud Abdel Hamid Elmesiry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090720
- Sponsor's protocol ID
- 36173//12/22
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Nofal SM, El-Mashad AM, Elmesiry AM, Abouelenain AM, Awny MM. Melatonin effects on the left ventricular function in neonates with persistent pulmonary hypertension. Eur J Pediatr. 2026 Apr 9;185(5):247. doi: 10.1007/s00431-026-06864-z.
PubMed 41954764
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Effects on the Left Ventricular Function in Neonates With Persistent Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07090720
- Acronym / sponsor ID
- 36173//12/22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 29 Jul 2025 (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 evaluate the effect of melatonin on the left ventricular function in neonates with persistent pulmonary hypertension
Detailed description
Persistent pulmonary hypertension of the newborn (PPHN) is a potentially deadly disorder in which the circulation of the fetus is unable to adjust to the extrauterine environment. Persistently high pulmonary pressures may cause right-to-left shunting, hypoxia, and right ventricular failure.
Melatonin, a neurohormone produced by the pineal gland, offers an exceptional defense against reactive oxygen species (ROS). Infants are unable to synthesize melatonin during their first few weeks of life, which may exacerbate oxidative stress in hypoxic conditions. Additionally, Melatonin's antioxidative capabilities have been shown in neonatal pulmonary and respiratory disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: MelatoninNeonates were given Melatonin. |
| Group II | Placebo comparator | Other: PlaceboNeonates received placebo. |
Who may qualify
- Ages
- 36 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Neonates of ≥ 36 weeks of gestational age.
- Both sexes.
- Admitted with persistent pulmonary hypertension.
Key exclusion criteria (7 listed)
- Preterm infants < 36 weeks of gestation.
- Infants with congenital heart diseases.
- Infants with dysrhythmia.
- Chromosomal abnormalities.
- Severe pathological jaundice.
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 |
|---|---|---|
| MelatoninNeonates were given Melatonin. | Drug | Group I |
| PlaceboNeonates received placebo. | Other | Group II |
Primary outcome
Left ventricle global longitudinal strain
Time frame: Immediately after medication (Up to 1 hour)
Left ventricle global longitudinal strain (LV-GLS) was recorded.
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 Jul 2025.
- Derived from this study: PubMed 41954764Nofal SM, El-Mashad AM, Elmesiry AM, Abouelenain AM, Awny MM. Melatonin effects on the left ventricular function in neonates with persistent pulmonary hypertension. Eur J Pediatr. 2026 Apr 9;185(5):247. doi: 10.1007/s00431-026-06864-z.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Melatonin in people with Melatonin and Left Ventricular Function, run by Tanta 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 7 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 Jul 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.
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?
Left ventricle global longitudinal strain (time frame: Immediately after medication (Up to 1 hour)). 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 NCT07090720, which also lists 1 linked publication.
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 Jul 2025.