Neonatal Hypoxic Ischemic Encephalopathy

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Review clinical trials related to Neonatal Hypoxic Ischemic Encephalopathy. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia

This prospective observational pilot study aims to evaluate the feasibility, accuracy, and safety of the SteadyTemp® wireless adhesive thermometer for continuous, non-invasive body temperature monitoring in neonates undergoing therapeutic hypothermia following hypoxic-ischemic encephalopathy. Currently, body temperature during therapeutic hypothermia is monitored using an invasive rectal temperature probe, which carries risks such as tissue injury, perforation, infection, and patient discomfort. The study will enroll ten neonates born at ≥36 weeks of gestation who require therapeutic hypothermia. During the rewarming phase of treatment, the SteadyTemp® adhesive thermometer will be applied to the right axillary area for approximately 10 hours while routine rectal temperature monitoring continues. Temperature measurements obtained with the adhesive thermometer will be compared with simultaneous rectal core temperature measurements. In addition, skin condition after removal of the adhesive patch will be assessed using the Neonatal Skin Condition Scale (NSCS) to evaluate local tolerability. The study seeks to answer the following research questions: Can the SteadyTemp® adhesive thermometer continuously and reliably monitor body temperature in neonates during therapeutic hypothermia? Do temperature measurements obtained with the non-invasive adhesive thermometer show sufficient agreement with standard invasive rectal temperature measurements, including temperatures below 36°C? Is prolonged application of the adhesive thermometer safe and well tolerated, without causing clinically relevant skin irritation? The findings from this pilot study will provide preliminary evidence on the feasibility and agreement of this non-invasive monitoring method and will inform the design of larger validation studies investigating whether the SteadyTemp® adhesive thermometer could serve as a safe alternative to invasive rectal temperature monitoring during therapeutic hypothermia in neonates.

Participants needed: 10
Trial details
Age: 3-1Biological sex: AllType: ObservationalSponsor: Medical University of GrazUpdated: Aug 11, 2026Locations: 1
Eligibility criteria

Neonates born at ≥36+0 weeks of gestation. [+2]

Gestational age <36+0 weeks. [+3]

Status: Recruiting

Neonatal Brain Ultrasound With CEUS and Elastography

The aim of our study is to investigate changes of brain perfusion and elasticity in neonates during the time that a neonate is adapting to live outside the womb and during diseases that are suspected to affect neonatal brain perfusion. We use contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography to evaluate the state of brain perfusion. We will study neonates recruited from the Neonatal Units of Turku University Hospital.

Participants needed: 100
Trial details
Phase: Phase 3Age: 1-6Biological sex: AllType: InterventionalSponsor: Turku University HospitalUpdated: Jan 15, 2026Locations: 1
Eligibility criteria

Babies less than 7 months treated at the neonatal units of Turku University hosp...

Pre-known genetic disease [+7]

Status: Recruiting

Feasibility and Safety of Intranasally Administered Breast Milk in HIE

This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.

Participants needed: 10
Trial details
Phase: Early Phase 1Age: Up to 48Biological sex: AllType: InterventionalSponsor: Semmelweis UniversityUpdated: May 22, 2025Locations: 1
Eligibility criteria

Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypo... [+4]

Congenital malformation [+5]

Status: Recruiting

Intranasal Breast Milk Therapy in HIE

This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term neurodevelopmental outcome compared to standard care.

Participants needed: 80
Trial details
Phase: Early Phase 1Age: Up to 48Biological sex: AllType: InterventionalSponsor: Semmelweis UniversityUpdated: Dec 24, 2024Locations: 1
Eligibility criteria

Moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypot... [+2]

Congenital malformation [+5]

Status: Not yet recruiting

Erythropoietin in HIE Neonate

this study is aim to delineate the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy the study is conducted to answer the question : is erythropoietin will improve neonatal hypoxic ischemic encephalopathy?

Participants needed: 3
Trial details
Phase: Early Phase 1Age: 1-1Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Sep 19, 2024Locations: 1
Eligibility criteria

neonates who more than 1 month [+1]