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RecruitingNCT05767476Updated Mar 14, 2023

Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia

An observational study in Encephalopathy, Hypoxic Ischemic, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 2 sites in Italy. Open to participants aged 10 Minutes to 6 Hours. Per ClinicalTrials.gov, last updated 2023-03-14.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Apr 2021; still recruiting 5 years 6 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
10 Minutes to 6 Hours
Sex
All
01

Study 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.
02

Conditions studied

  • Encephalopathy, Hypoxic Ischemic
03

In context

Hypoxia-Ischemia, Brain

261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.

This study's planned enrollment of 70 is below the median of 89 across 92 observational studies indexed under Hypoxia-Ischemia, Brain.

Browse Hypoxia-Ischemia, Brain studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Browse Fondazione Policlinico Universitario Agostino Gemelli IRCCS studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Minutes to 6 Hours
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypotermia

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • Newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia

    Diagnostic Test: Clinical and instrumental neurological assessment

Interventions

  • Diagnostic testClinical and instrumental neurological assessment

    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

06

What researchers measure

Primary outcomes

  1. Neurodevelopmental outcome

    the score in Griffiths Mental Development Scales (GMDS)

    Time frame: 24th months

Secondary outcomes

  1. Neurodevelopmental outcome

    the score in Wechsler Preschool and Primary Scale of Intelligence (WPPSI)

    Time frame: between 36th and 42th months

  2. Motor coordination outcome

    The score in Movement ABC (m-ABC)

    Time frame: between 42th and 48th months.

07

Study locations

2 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2021 (actual). Primary completion is estimated for Aug 2025, 52 months after the start.

Of 46 non-industry observational studies under Hypoxia-Ischemia, Brain, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20. This study's planned 52 months is above that.

Counting every sponsor, half of 50 studies reached it within 43 months; a quarter within 20.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2023
First posted
Mar 14, 2023
StartActual
Apr 28, 2021
Primary completionEst.
Aug 31, 2025
CompletionEst.
Dec 31, 2027
Last update
Mar 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05767476
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Romeo Domenico Marco (MD, PHD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Mar 14, 2023
Start date
Apr 28, 2021
Primary completion
Aug 31, 2025 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Mar 14, 2023

Study contacts

Domenico M Romeo, MD,PHD
Contact
domenicomarco.romeo@policlinicogemelli.it
00390630156391
Domenico M Romeo, MD,PHD
principal investigator · ChatolicUIT

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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