Clinical trial NCT05785481: Early Neurological Outcome in Newborns With Mild Encephalopathy:a Regional Network
Official title: Early Neurological Outcome in Newborns With Mild Encephalopathy:a Regional Network
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypoxic Encephalopathy
Keywords: Mild Hypoxic Encephalopathy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 27
Sex: ALL
Minimum age (years): 10
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with early diagnosis (within 6 hours of life) of mild HIE, who are not candidates for treatment with therapeutic hypothermia

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: early neurological outcome
timeFrame: between the seventh and 14th day of life
measure: early neurological outcome
timeFrame: at the 6th month
measure: early neurological outcome
timeFrame: at 12th month.
measure: early neurological outcome
timeFrame: at the 3th month
measure: early neurological outcome
timeFrame: at the 6th month.
measure: early neurological outcome
timeFrame: at the 12th month.
Secondary outcomes:
measure: Electroencephalographic and epilepsy outcome
timeFrame: between the 6 hours of life and 12th month.
measure: Neurodevelopmental outcome
timeFrame: 12th month
measure: Hospitalization
timeFrame: between birth until 12th month
measure: adverse events
timeFrame: between birth until 12th month
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli -IRRCS
Study officials:
affiliation: ChatolicUIT
name: Domenico M Romeo, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: