Newborn MorbidityNCT04785183
Antioxidant Effects of Melatonin in Preterm
A study testing Melatonin drops in people with Newborn Morbidity and Oxidative Stress, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" at 1 site in Italy.
Trial summary
Preterm infants are at risk of free radical mediated diseases from oxidative stress (OS) injury. Melatonin (MEL) is a powerful antioxidant and scavenger of free radicals. In preterm neonates, melatonin deficiency has been reported. Read more about this study
- Who is it for?
- Ages 1 hour to 6 hours
- Conditions the study is for
- Newborn Morbidity, Oxidative Stress, Pre-Term
- What is being tested?
- Melatonin drops
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 1 Sep 2020
- 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 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age <37 weeks
- Normal liver function tests
- Normal kidney function tests
Who cannot join
- All babies not born in the clinic
- All babies with severe congenital malformations
- Sepsis
- Inborn errors of metabolism
- Babies suffering from perinatal asphyxia
- Babies born from mothers with mental disorders
Show all 9Show fewer
- Sample hemolysis
- Insufficient sample
- withdraw informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Supplementation of Melatonin in Preterm Newborns: the Effects on Oxidative Stress
Preterm infants are at risk of free radical mediated diseases from oxidative stress (OS) injury. Melatonin (MEL) is a powerful antioxidant and scavenger of free radicals. In preterm neonates, melatonin deficiency has been reported. Several studies tested the efficacy of melatonin to counteract oxidative damage in diseases of newborns such as chronic lung disease, perinatal brain injury, necrotizing enterocolitis, retinopathy of prematurity and sepsis, giving promising results. In these studies, the dosages of melatonin varied over a wide range. The present study was designed to test the hypothesis that oral administration of melatonin reduced OS and consequentially, the occurrence of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD) in preterm newborns.
- Conditions
- Newborn Morbidity, Oxidative Stress, Pre-Term, Melatonin Deficiency
- Being tested
- Melatonin drops, Placebo
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin dropsDietary supplement
Melatonin oral administration
PlaceboOther
Oral 5% glucose
| Study group | Role | What they receive |
|---|---|---|
| Melatonin Group | Experimental | Not described Receives: Dietary Supplement: Melatonin drops |
| Control Group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the melatonin concentration
Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)
Measured: All participants will be evaluated at 24 hours of life
Measurement of the melatonin concentration
Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)
Measured: All participants will be evaluated at 48 hours of life
Secondary outcomes (6)
Measurement of AOPP
Evaluation of advanced oxidative protein products (AOPP) in treated group (MEL group) and controls (placebo group)
Measured: All participants will be evaluated at 24 hours of life
Measurement of NPBI
Evaluation of non protein binding iron (NPBI) in treated group (MEL group) and controls (placebo group)
Measured: All participants will be evaluated at 24 hours of life
Measurement of isoprostanes
Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group)
Measured: All participants will be evaluated at 24 hours of life
Measurement of AOPP
Evaluation of advanced oxidative protein products (AOPP) in treated group (MEL group) and controls (placebo group)
Measured: All participants will be evaluated at 48 hours of life
Measurement of NPBI
Evaluation of non protein binding iron (NPBI) in treated group (MEL group) and controls (placebo group)
Measured: All participants will be evaluated at 48 hours of life
Measurement of isoprostanes
Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group)
Measured: All participants will be evaluated at 48 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Jan 2019
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn MorbidityStudies 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
- Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785183
- Sponsor's protocol ID
- 42/18 - 2018
- Status last verified
- Mar 2021
- First submitted
- 16 Feb 2021
- Last updated
- 5 Mar 2021
- 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 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Supplementation of Melatonin in Preterm Newborns: the Effects on Oxidative Stress
- ClinicalTrials.gov ID
- NCT04785183
- Acronym / sponsor ID
- 42/18 - 2018
- Conditions
- Newborn Morbidity, Oxidative Stress, Pre-Term, Melatonin Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"University, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 5 Mar 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.
Preterm infants are at risk of free radical mediated diseases from oxidative stress (OS) injury. Melatonin (MEL) is a powerful antioxidant and scavenger of free radicals. In preterm neonates, melatonin deficiency has been reported. Several studies tested the efficacy of melatonin to counteract oxidative damage in diseases of newborns such as chronic lung disease, perinatal brain injury, necrotizing enterocolitis, retinopathy of prematurity and sepsis, giving promising results. In these studies, the dosages of melatonin varied over a wide range. The present study was designed to test the hypothesis that oral administration of melatonin reduced OS and consequentially, the occurrence of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD) in preterm newborns.
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 | Dietary Supplement: Melatonin drops |
| Control Group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 1 hour to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age <37 weeks
- Normal liver function tests
- Normal kidney function tests
Key exclusion criteria (9 listed)
- All babies not born in the clinic
- All babies with severe congenital malformations
- Sepsis
- Inborn errors of metabolism
- Babies suffering from perinatal asphyxia
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 dropsMelatonin oral administration | Dietary supplement | Melatonin Group |
| PlaceboOral 5% glucose | Other | Control Group |
Primary outcome
Measurement of the melatonin concentration
Time frame: All participants will be evaluated at 24 hours of life
Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)
Measurement of the melatonin concentration
Time frame: All participants will be evaluated at 48 hours of life
Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)
6 secondary outcomes
Measurement of AOPP
Time frame: All participants will be evaluated at 24 hours of life
Measurement of NPBI
Time frame: All participants will be evaluated at 24 hours of life
Measurement of isoprostanes
Time frame: All participants will be evaluated at 24 hours of life
Measurement of AOPP
Time frame: All participants will be evaluated at 48 hours of life
Measurement of NPBI
Time frame: All participants will be evaluated at 48 hours of life
Measurement of isoprostanes
Time frame: All participants will be evaluated at 48 hours of life
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 Mar 2021.
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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 drops in people with Newborn Morbidity and Oxidative Stress, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" at 1 site in Italy.
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 9 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 Mar 2021. 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 Italy. 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?
Measurement of the melatonin concentration (time frame: All participants will be evaluated at 24 hours of life). 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 5 Mar 2021.