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MalondialdehydeNCT04235673

Oral Melatonin as Neuroprotectant in Preterm Infants

A study testing melatonin in people with Malondialdehyde and Melatonin, run by Francesca Garofoli at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Preterm newborns survival rates are improved, but long-term disabilities are still common. Major destructive focal lesions became less common, the most predominant lesion at present is diffuse white matter (WM damage). Read more about this study

Who is it for?
Ages 25 to 30 weeks
Conditions the study is for
Malondialdehyde, Melatonin
What is being tested?
melatonin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
4 sitesItaly
Study dates
25 May 2020to 11 Oct 2022
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 25 to 30 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • preterm newborns gestational age GA < 29+6 weeks + day
  • able to receive min 20ml/kg/day enteral nutrition, within 96 hours from birth
  • written informed consent by both the parents.

Who cannot join

  • preterm newborns GA > 29+6 weeks + days
  • not able to receive enteral nutrition (min 20 ml/kg/die) within 96 hours of life
  • infants with genetic and/or congenital metabolic or chronic diseases
  • intraventricular hemorrhage (IVH) ≥ III,
  • parents refusing to sign a written informed consent

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Child and Adolescence Neuropsychiatry Unit, Children's Hospital "Spedali Civili" of Brescia, 25123 Brescia, Italy.

    Brescia, BS, 25123

  • Neonatal Intensive Care Unit, Children's Hospital, University Hospital "Spedali Civili" Brescia, 25123 Brescia, Italy.

    Brescia, BS, 25123

  • Fondazione IRCCS Mondino

    Pavia, PV, 27100

  • Neonatal Unit and NICU, Radiology, Clinical Chemistry Lab., Fondazione IRCCS Policlinico S. Matteo.

    Pavia, PV, 27100

Other trials in Italy

About this study

Official title: Oral Melatonin as Neuroprotectant in Preterm Infants .A Prospective, Double Blind vs Placebo, Parallel Arms Study

Preterm newborns survival rates are improved, but long-term disabilities are still common. Major destructive focal lesions became less common, the most predominant lesion at present is diffuse white matter (WM damage). Melatonin (ME) serves as a neuroprotectant cerebral ischemia through its potent anti-oxidant/-inflammatory effect. Preclinical studies demonstrated that protects the developing brain by preventing abnormal myelination and inflammatory glial reaction. Clinical studies demonstrated ME ability in reducing brain damage after neonatal Hypoxic Ischemic Encephalopathy (HIE) or preventing neonatal impairments due to antenatal/ post-natal injuries: preeclampsia, IntraUterineGrowthRestriction (IUGR), ventilation, Bronchopulmonary Dysplasia (BPD). ME has a good safety profile with no known adverse effects. This study aims to highlight that ME can prevent brain impairment due to premature birth. ME will be administered orally (3 mg/kg/die for 15 days to neonates born before 29+6 week gestation, in a prospective double blind, randomized vs placebo study, 2 parallel arms. ME and malondialdehyde (MDA), a lipid peroxidation product) levels before and at the end of treatment will be measured . Other outcomes: Cerebral ultrasounds (cUS); cerebral magnetic resonance imaging (cMRI), " Fagan test " eye tracking, ophthalmological, auditory, neurological/cognitive child assessments. Monitoring parental distress, which can influence the neurodevelopmental outcome in preterms.

Read the detailed description

About 552.000 infants are born in Italy each year, 1% of them with gestational age under 30 weeks. Survival rates are improved, but long-term disabilities are still common. Major destructive focal lesions became less common, the most predominant lesion at present is diffuse white matter (WM damage). The prevention of neurodevelopmental impairment is a major public health challenge and efforts are needed to test neuroprotective strategies. Melatonin (ME) serves as a neuroprotectant cerebral ischemia through its potent anti-oxidant/-inflammatory effect. Preclinical studies demonstrated that protects the developing brain by preventing abnormal myelination and inflammatory glial reaction. Clinical studies demonstrated ME ability in reducing brain damage after neonatal Hypoxic Ischemic Encephalopathy (HIE) or preventing neonatal impairments due to antenatal/ post-natal injuries: preeclampsia, IntraUterineGrowthRestriction (IUGR), ventilation, Bronchopulmonary Dysplasia (BPD). Ongoing studies are testing in premature neonates and pregnant women its neuroprotective properties. ME has a good safety profile with no known adverse effects.

This study aims to highlight that ME can prevent brain impairment due to premature birth. ME will be administered orally (3 mg/kg/die for 15 days within 96 hours from birth) to neonates born before 29+6 week gestation age (GA), in a prospective double blind, randomized vs placebo study, 2 parallel arms (30 preterm infants each). ME and malondialdehyde (MDA, a lipid peroxidation product) levels will be measured before and at the end of treatment. At birth, within 40 weeks of neonatal age, at 4-6 and at 24 months of age the following examinations are performed: Cerebral ultrasounds (cUS); cerebral magnetic resonance imaging (cMRI), during natural sleep (i.e. adopting sleep deprivation and/or feeding protocols); "Fagan test"eye tracking, ophthalmological, auditory brain stem evoked response (ABR), neurological/cognitive child assessments. Monitoring parental distress, which can influence the neurodevelopmental outcome in preterms.

Being tested
melatonin, placebo
Keywords
Preterm neonate, Neuroprotection, Malondialdehyde, Melatonin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • melatoninDietary supplement

    Also called not reported

    orally administered drops

  • placeboDrug

    Also called not reported

    orally administered drops

Study groups in NCT04235673
Study groupRoleWhat they receive
melatoninExperimentalmelatonin oral drops; 3 mg/kg/day for 15 days
Receives: Dietary Supplement: melatonin
placeboPlacebo comparatororal drops manufactured to mimic melatonin
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Malondialdehyde

    plasmatic concentration pg/ml

    Measured: 15 days

  2. Melatonin

    plasmatic concentration pg/ml

    Measured: 15 days

Secondary outcomes (3)

  1. Cranial ultrasound (cUS) Assessment

    to identify and score White Matter injuries

    Measured: up to 40 weeks

  2. Brain Magnetic Resonance Immaging (cMRI) Assessment

    Identify and score White Matter injuries

    Measured: up to 40 weeks

  3. Auditory brain stem evoked response (ABR) Assessments

    Identify and score auditory diseases

    Measured: up to 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start25 May 2020
  3. Primary completion1 Oct 2022
  4. Study completion11 Oct 2022

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04235673
Sponsor's protocol ID
20180004210 17/01/2018
Status last verified
Oct 2022
First submitted
23 May 2019
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Garofoli F, Asteggiano C, Minniti ML, Accorsi P, Albertini R, Angelini M, Aversa S, Ballante E, Cabini RF, Caporali C, Cociglio S, Franco V, Longo S, Malerba L, Materia V, Mazzocchi L, Naboni C, Palmisani M, Pullega C, Pisoni C, Preda L, Riboli A, Risso FM, Rognone E, Savini G, Simoncelli AM, Villani P, Tzialla C, Pinelli L, Fazzi E, Chiapparini L, Borgatti R, Ghirardello S, Pichiecchio A, Orcesi S. Early Oral Melatonin Supplementation Supports White Matter Maturation in Preterm Infants: Neuroprotective Insights of an Antioxidant Molecule. J Pineal Res. 2026 May;78(3):e70147. doi: 10.1111/jpi.70147.

    PubMed 42138165

  • Garofoli F, Longo S, Pisoni C, Accorsi P, Angelini M, Aversa S, Caporali C, Cociglio S, De Silvestri A, Fazzi E, Rizzo V, Tzialla C, Zecca M, Orcesi S. Oral melatonin as a new tool for neuroprotection in preterm newborns: study protocol for a randomized controlled trial. Trials. 2021 Jan 22;22(1):82. doi: 10.1186/s13063-021-05034-w.

    PubMed 33482894

Questions about this trial

What is this clinical trial studying?

A study testing melatonin in people with Malondialdehyde and Melatonin, run by Francesca Garofoli at 4 sites 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 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 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Malondialdehyde (time frame: 15 days). 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?

On the ClinicalTrials.gov record for NCT04235673, which also lists 2 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 25 Jul 2024.

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