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Prospective cohort study on mild neonatal hypoxic-ischemic encephalopathy treated with hypothermia

Prospective cohort study on mild neonatal hypoxic-ischemic encephalopathy treated with hypothermia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089920
Enrollment
Unknown
Registered
2024-09-19
Start date
2024-08-06
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxic ischemic encephalopathy, HIE

Interventions

Mild hypothermia treatment group:None
Non hypothermia treatment group:None

Sponsors

Peking University First Hospital Ningxia Women and Children’s Hospital (Ningxia Hui Autonomous Region Maternal and Child Health Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: All children diagnosed with mild HIE Diagnosis criteria for mild HIE in newborns: Diagnosed as mild HIE according to the modified Sarnat criteria. The specific criteria are: ? level of consciousness: excitement, irritability; ? Autonomous activities: frequent and symmetrical; ? Autonomic nervous system function (sympathetic nervous system): dilated pupils, tachycardia, normal or weakened gastrointestinal motility; ? Primitive reflex: weak suction reflex, strong embrace reflex, weak tension neck reflex; ? Strong olfactory response; ? Tendon reflex is active; ? Neuromuscular control: normal muscle tone, normal posture, or mild distal curvature.

Exclusion criteria

Exclusion criteria: Excluding those who meet one of the following criteria: ? gestational age<35 weeks, birth weight<2000g; ? Severe congenital malformations such as complex congenital heart disease, complex neurological abnormalities, trisomy 21, and other chromosomal abnormalities; ? The newborn survived upon discharge, but was lost to follow-up after discharge.

Design outcomes

Primary

MeasureTime frame
Neurodevelopmental indicators of two groups during follow-up up to 6 and 12 months of age (Griffiths Developmental Assessment Scale);

Secondary

MeasureTime frame
Two groups were followed up on physical development indicators (head circumference, length, weight) at 42 days, 3, 6, 9, and 12 months of age after birth;Mortality rate, presence of sepsis or not, coagulation dysfunction requiring transfusion therapy or not, thrombocytopenia;Mechanical ventilation time, duration of use of vasoactive drugs, days of parenteral nutrition;Is there a difference in the occurrence of liver injury and kidney injury;

Countries

China

Contacts

Public ContactYongjia Ji

Peking University First Hospital Ningxia Women and Children’s Hospital (Ningxia Hui Autonomous Region Maternal and Child Health Hospital)

jiyongjia_0824@126.com+86 138 9533 4450

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026