Early Neurological Outcome in Newborns With Mild Encephalopathy:a Regional Network

NCT05785481 | Unknown

• 1 other identifier: 2631
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic Encephalopathy

Keywords

Mild Hypoxic Encephalopathy

Outcome Measures

Primary Outcomes (6)

• early neurological outcome

  the percentage of patients with mild asphyxia with evidence of brain damage, defined by MRI

  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

  at the 6th month

• early neurological outcome

  the percentage of patients with mild asphyxia with evidence of brain damage, defined by EEG abnormalities

  at 12th month.

• early neurological outcome

  the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination

  at the 3th month

• early neurological outcome

  the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination

  at the 6th month.

• early neurological outcome

  the percentage of patients with mild asphyxia with evidence of brain damage, defined by neurological examination

  at the 12th month.

Secondary Outcomes (4)

• Electroencephalographic and epilepsy outcome

  between the 6 hours of life and 12th month.

• Neurodevelopmental outcome

  12th month

• Hospitalization

  between birth until 12th month

• adverse events

  between birth until 12th month

Study Arms (1)

Patients with early diagnosis (within 6 hours of life) of mild HIE

Diagnostic Test: Clinical and instrumental neurological assessment

Interventions

Clinical and instrumental neurological assessment DIAGNOSTIC_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.

Patients with early diagnosis (within 6 hours of life) of mild HIE

Eligibility Criteria

• Age: 10 Minutes - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli -IRRCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Hypoxia, Brain

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Domenico M Romeo, MD,PHD

  ChatolicUIT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Principal investigator

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 27, 2023
• Study Start: February 27, 2020
• Primary Completion: November 7, 2022
• Study Completion: December 31, 2024
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

IT (1)