Hypoxic EncephalopathyNCT05785481
Early Neurological Outcome in Newborns With Mild Encephalopathy:a Regional Network
An observational study of Hypoxic Encephalopathy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This is a multicenter prospective observational study that aims to determine the natural history of patients with early diagnosis (within 6 hours of life) of mild hipoxic ischemic encephalopaty (HIE), who are not candidates for treatment with therapeutic hypothermia. Read more about this study
- Who is it for?
- Ages 10 minutes to 6 hours
- Conditions the study is for
- Hypoxic Encephalopathy
- What is being tested?
- Clinical and instrumental neurological assessment
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- 27 Feb 2020to 31 Dec 2024
- Phase
- Observational
- 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 10 minutes to 6 hours
- All sexes
- No healthy volunteers
- Child
Study population: patients with early diagnosis (within 6 hours of life) of mild HIE, who are not candidates for treatment with therapeutic hypothermia
Who may be able to join
- patients born after the 36th week of gestational age, with signs of encephalopathy found between the 10th minute of life and 6h, presenting with one or more of the following signs of intrapartum hypoxia with a potential of hydrogeb (pH) ≤ 7 or an excess of bases (BE) ≥ 12 mmol/l in the first hour of life, measured on cord or arterial blood or an abnormal course of delivery (eg: fetal heart rate abnormalities, cord prolapse, uterine tear, haemorrhage/ trauma/ convulsive seizures/ maternal cardiorespiratory arrest; shoulder dystocia; meconium-dyed amniotic fluid or protracted second stage and the presence of an Apgar at 10 min ≤5 or the need for continuous respiratory support at 10 minutes.
Who cannot join
- mutes neurological objectivity;
- impossibility of recruitment within 6h;
- major congenital anomalies, brain malformations;
- neonatal abstinence syndrome;
- metabolic encephalopathies and severe growth restriction (birth weight ≤1800g);
- treatment with therapeutic hypothermia;
- refusal of consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli -IRRCS
Rome, 00168
About this study
This is a multicenter prospective observational study that aims to determine the natural history of patients with early diagnosis (within 6 hours of life) of mild hipoxic ischemic encephalopaty (HIE), who are not candidates for treatment with therapeutic hypothermia. The goal of this study is to learn about the early neurological outcome in babies with mild encephalopathy, as recent studies have shown how there is an increased risk of brain damage with a high incidence of resonance magnetic nuclear (RMN) anomalies and possible neurodevelopmental complications including learning or neuropsychological disorders, epilepsy, visual and sensory deficits. The main question aimed to answer is the identification of early possible predictive factors for an unfavorable outcome in order to undertake early rehabilitation programs and for the future planning of trials on early neuroprotection in the investigated population. Babies with early diagnosis (within 6h of life) of mild grade HIE not candidate for hypothermic treatment are subjected to clinical and instrumental assessments during the neonatal period:
- neurological objective exam according to the modified "Sarnat" score, Thompson score and Hammersmith Neonatal Neurological Examination (HINE) within 6 hours of life, 24 hours of life and before resignation;
- an Amplitude Electroencephalogram (aEEG) study within 6 hours of life, for 6 hours;
- cerebral ultrasound within 6 hours of life, in the third and seventh day of life;
- a brain magnetic resonance imaging study between the seventh and 14th day of life;
- an Electroencephalogram (EEG) evaluation within 7 days.
Read more
After resignation, all patients will be included in a minimum duration follow-up program of 12 months, with assessments at 3rd, 6th and 12th month of age:
- Hammersmith Neonatal Neurological Examination (HINE) and evaluation of the General Movements;
- evaluation of psychomotor development through Griffiths/Bayley III scales at the 12th month;
- EEG evaluation at the 6th and 12th month.
- Conditions
- Hypoxic Encephalopathy
- Being tested
- Clinical and instrumental neurological assessment
- Keywords
- Mild Hypoxic Encephalopathy
- Medical subject headings
- Hypoxia, 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
During the neonatal period:
neurological objective exam according to the modified Sarnat score, Thompson score and Hammersmith Neonatal Neurological Examination (HINE) within 6 hours of life, 24 hours of life and before resignation; an AEEG study within 6 hours of life, for 6 hours; cerebral ultrasound within 6 hours of life, in the third and seventh day of life; a brain magnetic resonance imaging study between the seventh and 14th day of life; an EEG evaluation within 7 days.
After resignation, all patients will be included in a minimum duration follow-up program of 12 months, with assessments at 3rd, 6th and 12th month of age:
Hammersmith Neonatal Neurological Examination (HINE) and evaluation of the General Movements; evaluation of psychomotor development through Griffiths/Bayley III scales at the 12th month; EEG evaluation at the 6th and 12th month.
| Study group | Role | What they receive |
|---|---|---|
| Patients with early diagnosis (within 6 hours of life) of mild HIE | 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.
early neurological outcome
the percentage of patients with mild asphyxia with evidence of brain damage, defined by MRI
Measured: between the seventh and 14th day of life
early neurological outcome
the percentage of patients with mild asphyxia with evidence of brain damage, defined by EEG abnormalities
Measured: at the 6th month
early neurological outcome
the percentage of patients with mild asphyxia with evidence of brain damage, defined by EEG abnormalities
Measured: at 12th month.
early neurological outcome
the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination
Measured: at the 3th month
early neurological outcome
the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination
Measured: at the 6th month.
early neurological outcome
the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination
Measured: at the 12th month.
Secondary outcomes (4)
Electroencephalographic and epilepsy outcome
percentage of abnormalities at electroencephalographic checks and presence of critical events
Measured: between the 6 hours of life and 12th month.
Neurodevelopmental outcome
percentage of abnormalities at Neurodevelopmental evaluation
Measured: 12th month
Hospitalization
Duration of Hospitalization
Measured: between birth until 12th month
adverse events
Death
Measured: between birth until 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start27 Feb 2020
- Primary completion7 Nov 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic EncephalopathyStudies 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
- 27 participants (actual)
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
- NCT05785481
- Sponsor's protocol ID
- 2631
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 27 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 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Neurological Outcome in Newborns With Mild Encephalopathy:a Regional Network
- ClinicalTrials.gov ID
- NCT05785481
- Acronym / sponsor ID
- 2631
- Conditions
- Hypoxic Encephalopathy
- Keywords
- Mild Hypoxic Encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 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.
This is a multicenter prospective observational study that aims to determine the natural history of patients with early diagnosis (within 6 hours of life) of mild hipoxic ischemic encephalopaty (HIE), who are not candidates for treatment with therapeutic hypothermia. The goal of this study is to learn about the early neurological outcome in babies with mild encephalopathy, as recent studies have shown how there is an increased risk of brain damage with a high incidence of resonance magnetic nuclear (RMN) anomalies and possible neurodevelopmental complications including learning or neuropsychological disorders, epilepsy, visual and sensory deficits. The main question aimed to answer is the identification of early possible predictive factors for an unfavorable outcome in order to undertake early rehabilitation programs and for the future planning of trials on early neuroprotection in the investigated population. Babies with early diagnosis (within 6h of life) of mild grade HIE not candidate for hypothermic treatment are subjected to clinical and instrumental assessments during the neonatal period:
- neurological objective exam according to the modified "Sarnat" score, Thompson score and Hammersmith Neonatal Neurological Examination (HINE) within 6 hours of life, 24 hours of life and before resignation;
- an Amplitude Electroencephalogram (aEEG) study within 6 hours of life, for 6 hours;
- cerebral ultrasound within 6 hours of life, in the third and seventh day of life;
- a brain magnetic resonance imaging study between the seventh and 14th day of life;
- an Electroencephalogram (EEG) evaluation within 7 days.
After resignation, all patients will be included in a minimum duration follow-up program of 12 months, with assessments at 3rd, 6th and 12th month of age:
- Hammersmith Neonatal Neurological Examination (HINE) and evaluation of the General Movements;
- evaluation of psychomotor development through Griffiths/Bayley III scales at the 12th month;
- EEG evaluation at the 6th and 12th month.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with early diagnosis (within 6 hours of life) of mild HIE | – | 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
- patients with early diagnosis (within 6 hours of life) of mild HIE, who are not candidates for treatment with therapeutic hypothermia
Key inclusion criteria (1 listed)
- patients born after the 36th week of gestational age, with signs of encephalopathy found between the 10th minute of life and 6h, presenting with one or more of the following signs of intrapartum hypoxia with a potential of hydrogeb (pH) ≤ 7 or an excess of bases (BE) ≥ 12 mmol/l in the first hour of life, measured on cord or arterial blood or an abnormal course of delivery (eg: fetal heart rate abnormalities, cord prolapse, uterine tear, haemorrhage/ trauma/ convulsive seizures/ maternal cardiorespiratory arrest; shoulder dystocia; meconium-dyed amniotic fluid or protracted second stage and the presence of an Apgar at 10 min ≤5 or the need for continuous respiratory support at 10 minutes.
Key exclusion criteria (7 listed)
- mutes neurological objectivity;
- impossibility of recruitment within 6h;
- major congenital anomalies, brain malformations;
- neonatal abstinence syndrome;
- metabolic encephalopathies and severe growth restriction (birth weight ≤1800g);
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 assessmentDuring the neonatal period: neurological objective exam according to the modified Sarnat score, Thompson score and Hammersmith Neonatal Neurological Examination (HINE) within 6 hours of life, 24 hours of life and before resignation; an AEEG study within 6 hours of life, for 6 hours; cerebral ultrasound within 6 hours of life, in the third and seventh day of life; a brain magnetic resonance imaging study between the seventh and 14th day of life; an EEG evaluation within 7 days. After resignation, all patients will be included in a minimum duration follow-up program of 12 months, with assessments at 3rd, 6th and 12th month of age: Hammersmith Neonatal Neurological Examination (HINE) and evaluation of the General Movements; evaluation of psychomotor development through Griffiths/Bayley III scales at the 12th month; EEG evaluation at the 6th and 12th month. | Diagnostic test | Patients with early diagnosis (within 6 hours of life) of mild HIE |
Primary outcome
early neurological outcome
Time frame: between the seventh and 14th day of life
the percentage of patients with mild asphyxia with evidence of brain damage, defined by MRI
early neurological outcome
Time frame: at the 6th month
the percentage of patients with mild asphyxia with evidence of brain damage, defined by EEG abnormalities
early neurological outcome
Time frame: at 12th month.
the percentage of patients with mild asphyxia with evidence of brain damage, defined by EEG abnormalities
early neurological outcome
Time frame: at the 3th month
the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination
early neurological outcome
Time frame: at the 6th month.
the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination
early neurological outcome
Time frame: at the 12th month.
the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination
4 secondary outcomes
Electroencephalographic and epilepsy outcome
Time frame: between the 6 hours of life and 12th month.
Neurodevelopmental outcome
Time frame: 12th month
Hospitalization
Time frame: between birth until 12th month
adverse events
Time frame: between birth until 12th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
Related trials for Hypoxic Encephalopathy
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
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
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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. This study is not recruiting at the moment.
Domenico M Romeo, MD,PHD principal investigator
ChatolicUIT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic Encephalopathy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 1 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: status not confirmed, as of the sponsor's last update on 27 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 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. 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?
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?
early neurological outcome (time frame: between the seventh and 14th day of life). The study lists 6 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 27 Mar 2023.