Encephalopathy, Hypoxic IschemicNCT05767476
Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
An observational study of Encephalopathy, Hypoxic Ischemic, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
Trial summary
The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia. Read more about this study
- Who is it for?
- Ages 10 minutes to 6 hours
- Conditions the study is for
- Encephalopathy, Hypoxic Ischemic
- What is being tested?
- Clinical and instrumental neurological assessment
- How many people
- 70 participants
- Where
- 2 sitesItaly
- Study dates
- 28 Apr 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 10 minutes to 6 hours
- All sexes
- No healthy volunteers
- Child
Study population: Newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypotermia
Who may be able to join
None listed.
Who cannot join
- Infants with:
- gestational age <35 weeks,
- severe foetal growth restriction (body weight <1800 g),
- inability to start therapeutic hypothermia within 6 hours of birth,
- other known causes of encephalopathy (chromosomopathies, brain malformations, metabolic encephalopathies, major congenital anomalies, neonatal withdrawal syndrome), - incoercible bleeding,
- refusal of consent by the parent/guardian/legal representative
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Domenico Marco Romeo
Rome, 00168
Domenico Marco Maurizio DR Romeo, MD,PHD, domenicomarco.romeo@policlinicogemelli.it
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli -IRRCS
Rome, 00168
Domenico M Romeo, MD,PHD, domenicomarco.romeo@policlinicogemelli.it
About this study
The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia.
The main questions it aims to answer are:
Read more
- Identify patients at risk of neuromotor, cognitive and epileptic sequelae
- Plan early rehabilitation programs and future trials on early neuroprotection in infant at risk of neurodevelopmental disability
Participants will be involved in serial assessment:
- Before and after therapeutic hypothermia and before discharge: neurological assessment, according to the modified Sarna (t) score, Thompson's score and Hammersmith Neonatal Neurological Examination (HNNE); General Movement Assessment
- Amplitude integrated electroencephalogram (aEEG) within 6 hours of life, for 6 hours.
- Neonatal Cranial Ultrasonography within 6 hours of life, in the third and seventh day of life.
- Brain magnetic resonance imaging between 7 and 14 days.
- Electroencephalogram (EEG) within 7 days.
After discharge study population will perform:
- EEG between 3 and 6 months.
- Neurological assessment using Hammersmith Infant Neurological Examination (HINE) at 3-6-9-12 months.
- General Movement Assessment at 3 months.
- Neurodevelopmental assessment using the Griffiths Mental Development Scales at 24 months.
- Cognitive assessment using the Wechsler Preschool and Primary Scale of Intelligence between 36 and 41 months.
- Motor performance assessment using Movement ABC between 42 and 48 months.
- Conditions
- Encephalopathy, Hypoxic Ischemic
- Being tested
- Clinical and instrumental neurological assessment
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and instrumental neurological assessmentDiagnostic test
Participants will be involved in serial assessment:
- Neonatal Cranial Ultrasonography
- Brain magnetic resonance imaging
- Neurological assessment
- Neurodevelopmental and cognitive assessment
- Electroencephalogram (EEG)
- Motor performance assessment
| Study group | Role | What they receive |
|---|---|---|
| Newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia | Not described Receives: Diagnostic Test: Clinical and instrumental neurological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental outcome
the score in Griffiths Mental Development Scales (GMDS)
Measured: 24th months
Secondary outcomes (2)
Neurodevelopmental outcome
the score in Wechsler Preschool and Primary Scale of Intelligence (WPPSI)
Measured: between 36th and 42th months
Motor coordination outcome
The score in Movement ABC (m-ABC)
Measured: between 42th and 48th months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start28 Apr 2021
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Encephalopathy, Hypoxic IschemicStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romeo Domenico Marco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Domenico M Romeo, MD,PHD, Principal investigator, ChatolicUIT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767476
- Sponsor's protocol ID
- 3544
- Status last verified
- Feb 2023
- First submitted
- 3 Mar 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
- ClinicalTrials.gov ID
- NCT05767476
- Acronym / sponsor ID
- 3544
- Conditions
- Encephalopathy, Hypoxic Ischemic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Mar 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.
The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia.
The main questions it aims to answer are:
- Identify patients at risk of neuromotor, cognitive and epileptic sequelae
- Plan early rehabilitation programs and future trials on early neuroprotection in infant at risk of neurodevelopmental disability
Participants will be involved in serial assessment:
- Before and after therapeutic hypothermia and before discharge: neurological assessment, according to the modified Sarna (t) score, Thompson's score and Hammersmith Neonatal Neurological Examination (HNNE); General Movement Assessment
- Amplitude integrated electroencephalogram (aEEG) within 6 hours of life, for 6 hours.
- Neonatal Cranial Ultrasonography within 6 hours of life, in the third and seventh day of life.
- Brain magnetic resonance imaging between 7 and 14 days.
- Electroencephalogram (EEG) within 7 days.
After discharge study population will perform:
- EEG between 3 and 6 months.
- Neurological assessment using Hammersmith Infant Neurological Examination (HINE) at 3-6-9-12 months.
- General Movement Assessment at 3 months.
- Neurodevelopmental assessment using the Griffiths Mental Development Scales at 24 months.
- Cognitive assessment using the Wechsler Preschool and Primary Scale of Intelligence between 36 and 41 months.
- Motor performance assessment using Movement ABC between 42 and 48 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia | – | Diagnostic Test: Clinical and instrumental neurological assessment |
Who may qualify
- Ages
- 10 minutes to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypotermia
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- gestational age <35 weeks,
- severe foetal growth restriction (body weight <1800 g),
- inability to start therapeutic hypothermia within 6 hours of birth,
- other known causes of encephalopathy (chromosomopathies, brain malformations, metabolic encephalopathies, major congenital anomalies, neonatal withdrawal syndrome), - incoercible bleeding,
- refusal of consent by the parent/guardian/legal representative
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 |
|---|---|---|
| Clinical and instrumental neurological assessmentParticipants will be involved in serial assessment: * Neonatal Cranial Ultrasonography * Brain magnetic resonance imaging * Neurological assessment * Neurodevelopmental and cognitive assessment * Electroencephalogram (EEG) * Motor performance assessment | Diagnostic test | Newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia |
Primary outcome
Neurodevelopmental outcome
Time frame: 24th months
the score in Griffiths Mental Development Scales (GMDS)
2 secondary outcomes
Neurodevelopmental outcome
Time frame: between 36th and 42th months
Motor coordination outcome
Time frame: between 42th and 48th months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
Related trials for Encephalopathy, Hypoxic Ischemic
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
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.
Domenico M Romeo, MD,PHD principal investigator
ChatolicUIT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalopathy, Hypoxic Ischemic, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 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 0 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: looking for participants now, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domenico M Romeo, MD,PHD (00390630156391, domenicomarco.romeo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopmental outcome (time frame: 24th months). 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 14 Mar 2023.