Status:
COMPLETED
Neonatal Electrical Activity at Different Altitude Levels
Lead Sponsor:
Children's Hospital of Fudan University
Conditions:
Altitude Hypoxia
Neonatal Encephalopathy
Eligibility:
All Genders
Up to 72 years
Brief Summary
In this study, the objective is to compare neonatal cerebral electrical activity within 3 days after birth across different altitude areas using amplitude-integrated electroencephalography (aEEG), and...
Eligibility Criteria
Inclusion
- Singleton term infants (gestational age between 37 0/7 and 41 6/7 weeks) born in the participating hospital.
- Infants appear well as defined by normal vital signs (heart rate ranging from 110 to 180 beats/min, respiratory rate ranging from 30 to 60 breaths/min, temperature ranging from 36.5°C to 37.5°C), absence of signs of illness such as cyanosis, respiratory distress and heart murmur.
- The mother is permanent residence of the current altitude level and live in the study area for the entire duration of pregnancy.
Exclusion
- Need for supplemental oxygen or assisted ventilation.
- Any evidence of intrauterine distress such as meconium-stained amniotic fluid, Apgar score \<7 at 1 or 5 min.
- Referred to neonatal intensive care unit or neonatology department for any reason other than observation.
- With major congenital anomaly.
- Probes cannot be properly placed due to scalp lesions or hematomas.
- Reject or withdraw from the study.
Key Trial Info
Start Date :
June 12 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 8 2024
Estimated Enrollment :
531 Patients enrolled
Trial Details
Trial ID
NCT05966714
Start Date
June 12 2023
End Date
October 8 2024
Last Update
February 19 2025
Active Locations (2)
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1
Yangfang Li
Kunming, Yunnan, China
2
Children Hospital of Fudan University
Shanghai, China, 201102