Assessing brain development in newborns with oxygen deprivation treated with cooling therapy
Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
This study is trying to find early signs of brain problems in newborns who had a lack of oxygen and were treated with cooling therapy to help plan better care for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 10 Minutes to 6 Hours |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 2 sites (Rome and 1 other locations) |
| Trial ID | NCT05767476 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify early indicators of poor neurodevelopmental outcomes in newborns suffering from hypoxic-ischemic encephalopathy who are treated with therapeutic hypothermia. It involves a series of neurological, neurophysiological, and neuroimaging assessments conducted before and after the cooling therapy. The study seeks to pinpoint infants at risk for neuromotor, cognitive, and epileptic issues, enabling the planning of early rehabilitation programs and future neuroprotection trials. Key assessments include neurological scoring, electroencephalogram monitoring, and cranial ultrasonography.
Who should consider this trial
Good fit: Ideal candidates include infants with a gestational age of 35 weeks or more and a body weight of at least 1800 grams who exhibit signs of moderate to severe encephalopathy due to intrapartum hypoxia.
Not a fit: Patients who do not meet the eligibility criteria, such as those with less than 35 weeks of gestation or those without signs of encephalopathy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early interventions for newborns at risk of neurodevelopmental disabilities.
How similar studies have performed: Other studies have shown promise in using therapeutic hypothermia for similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rome and 1 other locations
- Domenico Marco Romeo — Rome, Italy (Recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli -IRRCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Domenico M Romeo, MD,PHD — ChatolicUIT
- Study coordinator: Domenico M Romeo, MD,PHD
- Email: domenicomarco.romeo@policlinicogemelli.it
- Phone: 00390630156391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.