NCT05767476 Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
| NCT ID | NCT05767476 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Encephalopathy, Hypoxic Ischemic |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-04-28 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2021-04-28 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria:All infants with gestational age ≥ 35 weeks and with a body weight ≥ 1800 g were considered eligible, if they satisfied the following criteria: * Intrapartum hypoxia defined as follows: potential of hydrogen (pH)≤ 7.0 or B.E. ≥ 16 millimole liters (mmo/L) in the 1st hour of life, obtained from cord or arterial blood, or (ii) pathological intra-partum course (e.g., abnormal foetal heart rate, cord prolapse, uterine rupture, maternal haemorrhage/trauma/epileptic seizures/cardiorespiratory arrest, shoulder dystocia, fluid meconium-stained amniotic), or Apgar score ≤5 or continuous respiratory support at 10 minutes. * Signs of moderate or severe encephalopathy according to the Sarna (t) score and Sarna (t) staging, performed at 30-60 minutes of life: stage 2 (lethargic, poor spontaneous activity, distal flexion posture, hypotonia, weak primitive reflexes, myotic pupils, bradycardia or periodic breathing) or stage 3 (stupor/coma, decerebrate posture, spontaneous activity absent, flaccidity, primitive reflexes absent, non-reactive pupils or apnoea). * Amplitude integrated electroencephalogram( aEEG ) by Cerebral Functional Monitoring (CFM) or electroencephalogram (EEG) for at least 30 minutes, which shows either moderate or severe electroencephalographic anomalies, or the presence of convulsions. All enrolled infants underwent therapeutic hypothermia according to the international guideline for 72 hours. Exclusion Criteria: 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
Contact & Investigator
Domenico M Romeo, MD,PHD
PRINCIPAL INVESTIGATOR
ChatolicUIT
Frequently Asked Questions
Who can join the NCT05767476 clinical trial?
This trial is open to participants of all sexes, aged 10 Minutes or older, up to 6 Hours, studying Encephalopathy, Hypoxic Ischemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05767476 currently recruiting?
Yes, NCT05767476 is actively recruiting participants. Contact the research team at domenicomarco.romeo@policlinicogemelli.it for enrollment information.
Where is the NCT05767476 trial being conducted?
This trial is being conducted at Rome, Italy, Rome, Italy.
Who is sponsoring the NCT05767476 clinical trial?
NCT05767476 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Domenico M Romeo, MD,PHD at ChatolicUIT. The trial plans to enroll 70 participants.