Hypoxic-Ischemic EncephalopathyMELPRONCT03806816
Use of Melatonin for Neuroprotection in Asphyxiated Newborns
A study testing Melatonin in people with Hypoxic-Ischemic Encephalopathy and Cell Damage, run by University Hospital of Ferrara at 6 sites in 2 countries.
Trial summary
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Hypoxic-Ischemic Encephalopathy (HIE) occurs in 3-5 per 1000 births. Only 47% of neonates have normal outcomes. Read more about this study
- Who is it for?
- Ages 1 hour to 6 hours
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Cell Damage, Asphyxia Perinatal
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 13 Dec 2018to 31 Dec 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 1 hour to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age > 35 weeks and weight > 1800 gr
- Apgar score < 5 at 10 minutes o need for cardiopulmonary resuscitation at 10 minutes or evidence of base excess > 12 mmol/L or pH < 7,0 at initial blood gas analyses
- evidence of moderate or severa encephalopathy graded according to Sarnat\&Sarnat neurological evaluation
- abnormal amplitude integrated electroencephalography
Who cannot join
- suspected inborn errors of metabolism
- major chromosomal congenital defects
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Italy5 sites, 5 recruiting
- Recruiting
ospdale di Bolzano
Bolzano
Elisabetta Chiodin, MD
Alex Staffler, MD
- Recruiting
Bufalini Hospital Cesena
Cesena
MARCELLO Stella, marcello.stella@auslromagna.it
Elisa Mariani, elisa.mariani@auslromagna.it
- Recruiting
University Hospital "Sant'Anna" of Ferrara
Ferrara, 44124
Anna Tarocco, MD, +390532236014, anna.tarocco@unife.it
Paolo Pinton, Prof, +390532455802, paolo.pinton@unife.it
- Recruiting
ospedale San Salvatore
L’Aquila
Eugenia Maranella, MD
Sandra Di Fabio, MD
- Recruiting
Infermi Hospital Rimini
Rimini, 47923
Gina Ancora, MD PhD, +390541705445, gina.ancora@auslromagna.it
Miria Natile, MD, +390541705445, mirianatile@gmail.com
Holy See1 site, 1 recruiting
- Recruiting
Ospedale Pediatrico Bambin Gesù
Vatican City
Immacolata Savarese, MD
Andrea Dotta, MD
About this study
Official title: Use of Melatonin for Neuroprotection in Term Infants With Hypoxic-ischaemic Encephalopathy
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Hypoxic-Ischemic Encephalopathy (HIE) occurs in 3-5 per 1000 births. Only 47% of neonates have normal outcomes. The neurodevelopmental consequences of brain injury for asphyxiated term infants include cerebral palsy, severe intellectual disabilities and also a number of minor behavioural and cognitive deficits. However, there are very few therapeutic strategies for the prevention or treatment of brain damage. The gold standard is hypothermic treatment but, according to the literature, melatonin potentially acts in synergy with hypothermia for neuroprotection and to improve neurologic outcomes. Melatonin appears to be a good candidate because of its different protective effects including reactive oxygen species scavenging, excitotoxic cascade blockade, modulation of neuroinflammatory pathways.
The research study will evaluate the neuroprotective properties and the effects of Melatonin in association with therapeutic hypothermia for hypoxic ischemic encephalopathy.
Read the detailed description
It is a randomized double blind, placebo controlled trial on 100 neonates with moderate to moderately to severe hypoxic ischemic encephalopathy (HIE) . HIE infants are randomized into two groups: Whole body cooling group (N = 50 receive 72 hours of whole body hypothermia) and melatonin/ hypothermia group (N = 50; receive hypothermia and 5 daily enteral doses of melatonin 10 mg/kg). Serum melatonin and autophagy levels are measured at enrollment, daily during the hypothermic treatment, at day 5 and 7 for the two HIE groups.
aEEG will be performed for 72 hrs during the hypothermic treatment and the re-warming. MRI and Spectroscopy analysis will be performed between day 5 and 7 of. After hospital discharge the infants will enter a follow-up program consisting in periodic clinical and developmental assessments until 2 years of age corrected for prematurity. An expert psychologist and a neonatologist will assess neurodevelopmental outcome using the Bayley Scales III at 6-12-24 months of corrected age.
- Being tested
- Melatonin, PLACEBO group
- Keywords
- autophagy, neuroprotection, melatonin, Hypoxic-Ischemic Encephalopathy, hypothermia, newborn, neurological outcome, perinatal asphyxia
- Medical subject headings
- Hypoxia-Ischemia, Brain, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Also called Buona Circadiem
5 daily enteral doses of melatonin 10 mg/kg. (=2 ml/kg)
PLACEBO groupOther
Also called placebo
5 daily enteral doses of placebo 2 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| HYPOTHERMIA / MELATONIN group | Experimental | HIE infants who will receive melatonin in addition to the routine cooling treatment Receives: Dietary Supplement: Melatonin |
| HYPOTHERMIA / PLACEBO group | Experimental | HIE infants who will not receive melatonin in addition to the routine cooling treatment Receives: Other: PLACEBO group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley III scale
Bayley scale of infant and toddler development. It measures developmental skills reached by infant and young children between 1 month and 42 months The scale is subdivided into 5 subscales Cognitive,Receptive communication,Expressive communication,Fine motor ,Gross motor.Receptive and expressive communication have a composite in language score So as fine and gross motor in motor score For all subtests raw scores correspond to scaled scores ranging from 1 to 19 with a mean of 10 and SD of 3 The composite scores are given by the sum of the corresponding subtests scaled scores.
Two parent-reported scales (Social-Emotional and Adaptive Behavior) will be collected.
Measured: 12 months
Secondary outcomes (4)
brain MRI
to evaluate the presence of deep grey matter, PLIC, white matter, brainstem and hippocampus lesions
Measured: between the 5th and 7th days of life
continuous aEEG
Al Naqueeb classification for aEEG will be used.Background voltage pattern will be scored in NORMAL (Lower margin >5μV,Upper margin >10μV The activity is continuous), MODERATELY ABORMAL (Lower margin <5μV, upper margin >10μV,The activity is moderately discontinuous)SEVERELY ABNORMAL/ SUPPRESSED (Lower margin <5μV, upper margin <10μV)
Measured: Continuous monitoring for the first 72 hours and for the rewarmed
Plasma Concentration of Melatonin
UPLC-Massa Acquity-Xevo TQD (Waters) will be used to measure melatonin concentrations in the plasma
Measured: at birth, 24 hours, 48 hours, 72 hours, 5 days, 7 days of life
ATG5 Plasma concentration
ELISA test will be used to measure plasma levels of ATG5
Measured: at birth, 24 hours, 48 hours, 72 hours, 5 days, 7 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start13 Dec 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- AUSL Romagna Rimini
- Responsible party
- Principal investigator, Anna Tarocco, University Hospital of Ferrara
- Investigators
- Anna Tarocco, MD, Principal investigator, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806816
- Sponsor's protocol ID
- 23/2018/SPER/AOUFE
- Acronym
- MELPRO
- Status last verified
- Oct 2019
- First submitted
- 14 Jan 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Q, Lv H, Lu L, Ren P, Li L. Neonatal hypoxic-ischemic encephalopathy: emerging therapeutic strategies based on pathophysiologic phases of the injury. J Matern Fetal Neonatal Med. 2019 Nov;32(21):3685-3692. doi: 10.1080/14767058.2018.1468881. Epub 2018 May 2.
PubMed 29681183Hassell KJ, Ezzati M, Alonso-Alconada D, Hausenloy DJ, Robertson NJ. New horizons for newborn brain protection: enhancing endogenous neuroprotection. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F541-52. doi: 10.1136/archdischild-2014-306284. Epub 2015 Jun 10.
PubMed 26063194McAdams RM, Juul SE. Neonatal Encephalopathy: Update on Therapeutic Hypothermia and Other Novel Therapeutics. Clin Perinatol. 2016 Sep;43(3):485-500. doi: 10.1016/j.clp.2016.04.007. Epub 2016 Jun 22.
PubMed 27524449Ramos E, Patino P, Reiter RJ, Gil-Martin E, Marco-Contelles J, Parada E, de Los Rios C, Romero A, Egea J. Ischemic brain injury: New insights on the protective role of melatonin. Free Radic Biol Med. 2017 Mar;104:32-53. doi: 10.1016/j.freeradbiomed.2017.01.005. Epub 2017 Jan 6.
PubMed 28065781Balduini W, Carloni S, Perrone S, Bertrando S, Tataranno ML, Negro S, Proietti F, Longini M, Buonocore G. The use of melatonin in hypoxic-ischemic brain damage: an experimental study. J Matern Fetal Neonatal Med. 2012 Apr;25 Suppl 1:119-24. doi: 10.3109/14767058.2012.663232. Epub 2012 Mar 5.
PubMed 22348528Parikh P, Juul SE. Neuroprotective Strategies in Neonatal Brain Injury. J Pediatr. 2018 Jan;192:22-32. doi: 10.1016/j.jpeds.2017.08.031. Epub 2017 Oct 12. No abstract available.
PubMed 29031859Martinello K, Hart AR, Yap S, Mitra S, Robertson NJ. Management and investigation of neonatal encephalopathy: 2017 update. Arch Dis Child Fetal Neonatal Ed. 2017 Jul;102(4):F346-F358. doi: 10.1136/archdischild-2015-309639. Epub 2017 Apr 6.
PubMed 28389438Shea KL, Palanisamy A. What can you do to protect the newborn brain? Curr Opin Anaesthesiol. 2015 Jun;28(3):261-6. doi: 10.1097/ACO.0000000000000184.
PubMed 25827279Alonso-Alconada D, Alvarez A, Arteaga O, Martinez-Ibarguen A, Hilario E. Neuroprotective effect of melatonin: a novel therapy against perinatal hypoxia-ischemia. Int J Mol Sci. 2013 Apr 29;14(5):9379-95. doi: 10.3390/ijms14059379.
PubMed 23629670Fan X, van Bel F. Pharmacological neuroprotection after perinatal asphyxia. J Matern Fetal Neonatal Med. 2010 Oct;23 Suppl 3:17-9. doi: 10.3109/14767058.2010.505052.
PubMed 20695757Cilio MR, Ferriero DM. Synergistic neuroprotective therapies with hypothermia. Semin Fetal Neonatal Med. 2010 Oct;15(5):293-8. doi: 10.1016/j.siny.2010.02.002. Epub 2010 Mar 7.
PubMed 20207600Aly H, Elmahdy H, El-Dib M, Rowisha M, Awny M, El-Gohary T, Elbatch M, Hamisa M, El-Mashad AR. Melatonin use for neuroprotection in perinatal asphyxia: a randomized controlled pilot study. J Perinatol. 2015 Mar;35(3):186-91. doi: 10.1038/jp.2014.186. Epub 2014 Nov 13.
PubMed 25393080Fulia F, Gitto E, Cuzzocrea S, Reiter RJ, Dugo L, Gitto P, Barberi S, Cordaro S, Barberi I. Increased levels of malondialdehyde and nitrite/nitrate in the blood of asphyxiated newborns: reduction by melatonin. J Pineal Res. 2001 Nov;31(4):343-9. doi: 10.1034/j.1600-079x.2001.310409.x.
PubMed 11703564Ahmad QM, Chishti AL, Waseem N. Role of melatonin in management of hypoxic ischaemic encephalopathy in newborns: A randomized control trial. J Pak Med Assoc. 2018 Aug;68(8):1233-1237.
PubMed 30108392Roohbakhsh A, Shamsizadeh A, Hayes AW, Reiter RJ, Karimi G. Melatonin as an endogenous regulator of diseases: The role of autophagy. Pharmacol Res. 2018 Jul;133:265-276. doi: 10.1016/j.phrs.2018.01.022. Epub 2018 Feb 3.
PubMed 29408249
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Melatonin for Neuroprotection in Term Infants With Hypoxic-ischaemic Encephalopathy
- ClinicalTrials.gov ID
- NCT03806816
- Acronym / sponsor ID
- MELPRO / 23/2018/SPER/AOUFE
- Keywords
- autophagy, neuroprotection, melatonin, Hypoxic-Ischemic Encephalopathy, hypothermia, newborn, neurological outcome, perinatal asphyxia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- AUSL Romagna Rimini
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Jan 2019 (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.
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Hypoxic-Ischemic Encephalopathy (HIE) occurs in 3-5 per 1000 births. Only 47% of neonates have normal outcomes. The neurodevelopmental consequences of brain injury for asphyxiated term infants include cerebral palsy, severe intellectual disabilities and also a number of minor behavioural and cognitive deficits. However, there are very few therapeutic strategies for the prevention or treatment of brain damage. The gold standard is hypothermic treatment but, according to the literature, melatonin potentially acts in synergy with hypothermia for neuroprotection and to improve neurologic outcomes. Melatonin appears to be a good candidate because of its different protective effects including reactive oxygen species scavenging, excitotoxic cascade blockade, modulation of neuroinflammatory pathways.
The research study will evaluate the neuroprotective properties and the effects of Melatonin in association with therapeutic hypothermia for hypoxic ischemic encephalopathy.
Detailed description
It is a randomized double blind, placebo controlled trial on 100 neonates with moderate to moderately to severe hypoxic ischemic encephalopathy (HIE) . HIE infants are randomized into two groups: Whole body cooling group (N = 50 receive 72 hours of whole body hypothermia) and melatonin/ hypothermia group (N = 50; receive hypothermia and 5 daily enteral doses of melatonin 10 mg/kg). Serum melatonin and autophagy levels are measured at enrollment, daily during the hypothermic treatment, at day 5 and 7 for the two HIE groups.
aEEG will be performed for 72 hrs during the hypothermic treatment and the re-warming. MRI and Spectroscopy analysis will be performed between day 5 and 7 of. After hospital discharge the infants will enter a follow-up program consisting in periodic clinical and developmental assessments until 2 years of age corrected for prematurity. An expert psychologist and a neonatologist will assess neurodevelopmental outcome using the Bayley Scales III at 6-12-24 months of corrected age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HYPOTHERMIA / MELATONIN group | Experimental | Dietary Supplement: MelatoninHIE infants who will receive melatonin in addition to the routine cooling treatment |
| HYPOTHERMIA / PLACEBO group | Experimental | Other: PLACEBO groupHIE infants who will not receive melatonin in addition to the routine cooling treatment |
Who may qualify
- Ages
- 1 hour to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- gestational age > 35 weeks and weight > 1800 gr
- Apgar score < 5 at 10 minutes o need for cardiopulmonary resuscitation at 10 minutes or evidence of base excess > 12 mmol/L or pH < 7,0 at initial blood gas analyses
- evidence of moderate or severa encephalopathy graded according to Sarnat\&Sarnat neurological evaluation
- abnormal amplitude integrated electroencephalography
Key exclusion criteria (2 listed)
- suspected inborn errors of metabolism
- major chromosomal congenital defects
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 |
|---|---|---|
| MelatoninAlso: Buona Circadiem5 daily enteral doses of melatonin 10 mg/kg. (=2 ml/kg) | Dietary supplement | HYPOTHERMIA / MELATONIN group |
| PLACEBO groupAlso: placebo5 daily enteral doses of placebo 2 ml/kg | Other | HYPOTHERMIA / PLACEBO group |
Primary outcome
Bayley III scale
Time frame: 12 months
Bayley scale of infant and toddler development. It measures developmental skills reached by infant and young children between 1 month and 42 months The scale is subdivided into 5 subscales Cognitive,Receptive communication,Expressive communication,Fine motor ,Gross motor.Receptive and expressive communication have a composite in language score So as fine and gross motor in motor score For all subtests raw scores correspond to scaled scores ranging from 1 to 19 with a mean of 10 and SD of 3 The composite scores are given by the sum of the corresponding subtests scaled scores. Two parent-reported scales (Social-Emotional and Adaptive Behavior) will be collected.
4 secondary outcomes
brain MRI
Time frame: between the 5th and 7th days of life
continuous aEEG
Time frame: Continuous monitoring for the first 72 hours and for the rewarmed
Plasma Concentration of Melatonin
Time frame: at birth, 24 hours, 48 hours, 72 hours, 5 days, 7 days of life
ATG5 Plasma concentration
Time frame: at birth, 24 hours, 48 hours, 72 hours, 5 days, 7 days of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Results publication: PubMed 29681183Wang Q, Lv H, Lu L, Ren P, Li L. Neonatal hypoxic-ischemic encephalopathy: emerging therapeutic strategies based on pathophysiologic phases of the injury. J Matern Fetal Neonatal Med. 2019 Nov;32(21):3685-3692. doi: 10.1080/14767058.2018.1468881. Epub 2018 May 2.
- Results publication: PubMed 26063194Hassell KJ, Ezzati M, Alonso-Alconada D, Hausenloy DJ, Robertson NJ. New horizons for newborn brain protection: enhancing endogenous neuroprotection. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F541-52. doi: 10.1136/archdischild-2014-306284. Epub 2015 Jun 10.
- Results publication: PubMed 27524449McAdams RM, Juul SE. Neonatal Encephalopathy: Update on Therapeutic Hypothermia and Other Novel Therapeutics. Clin Perinatol. 2016 Sep;43(3):485-500. doi: 10.1016/j.clp.2016.04.007. Epub 2016 Jun 22.
- Results publication: PubMed 28065781Ramos E, Patino P, Reiter RJ, Gil-Martin E, Marco-Contelles J, Parada E, de Los Rios C, Romero A, Egea J. Ischemic brain injury: New insights on the protective role of melatonin. Free Radic Biol Med. 2017 Mar;104:32-53. doi: 10.1016/j.freeradbiomed.2017.01.005. Epub 2017 Jan 6.
- Results publication: PubMed 22348528Balduini W, Carloni S, Perrone S, Bertrando S, Tataranno ML, Negro S, Proietti F, Longini M, Buonocore G. The use of melatonin in hypoxic-ischemic brain damage: an experimental study. J Matern Fetal Neonatal Med. 2012 Apr;25 Suppl 1:119-24. doi: 10.3109/14767058.2012.663232. Epub 2012 Mar 5.
- Results publication: PubMed 29031859Parikh P, Juul SE. Neuroprotective Strategies in Neonatal Brain Injury. J Pediatr. 2018 Jan;192:22-32. doi: 10.1016/j.jpeds.2017.08.031. Epub 2017 Oct 12. No abstract available.
- Results publication: PubMed 28389438Martinello K, Hart AR, Yap S, Mitra S, Robertson NJ. Management and investigation of neonatal encephalopathy: 2017 update. Arch Dis Child Fetal Neonatal Ed. 2017 Jul;102(4):F346-F358. doi: 10.1136/archdischild-2015-309639. Epub 2017 Apr 6.
- Results publication: PubMed 25827279Shea KL, Palanisamy A. What can you do to protect the newborn brain? Curr Opin Anaesthesiol. 2015 Jun;28(3):261-6. doi: 10.1097/ACO.0000000000000184.
- Results publication: PubMed 23629670Alonso-Alconada D, Alvarez A, Arteaga O, Martinez-Ibarguen A, Hilario E. Neuroprotective effect of melatonin: a novel therapy against perinatal hypoxia-ischemia. Int J Mol Sci. 2013 Apr 29;14(5):9379-95. doi: 10.3390/ijms14059379.
- Results publication: PubMed 20695757Fan X, van Bel F. Pharmacological neuroprotection after perinatal asphyxia. J Matern Fetal Neonatal Med. 2010 Oct;23 Suppl 3:17-9. doi: 10.3109/14767058.2010.505052.
- Results publication: PubMed 20207600Cilio MR, Ferriero DM. Synergistic neuroprotective therapies with hypothermia. Semin Fetal Neonatal Med. 2010 Oct;15(5):293-8. doi: 10.1016/j.siny.2010.02.002. Epub 2010 Mar 7.
- Results publication: PubMed 25393080Aly H, Elmahdy H, El-Dib M, Rowisha M, Awny M, El-Gohary T, Elbatch M, Hamisa M, El-Mashad AR. Melatonin use for neuroprotection in perinatal asphyxia: a randomized controlled pilot study. J Perinatol. 2015 Mar;35(3):186-91. doi: 10.1038/jp.2014.186. Epub 2014 Nov 13.
- 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.
Anna Tarocco, MD principal investigator
University Hospital of Ferrara
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Hypoxic-Ischemic Encephalopathy and Cell Damage, run by University Hospital of Ferrara at 6 sites in 2 countries.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Holy See. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Tarocco, MD (+390532236014, anna.tarocco@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley III scale (time frame: 12 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 NCT03806816, which also lists 15 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 11 Oct 2019.