Neonatal Electrical Activity at Different Altitude Levels

Fudan University

Status: Completed

Conditions: Altitude Hypoxia; Neonatal Encephalopathy

Treatments: Device: aEEG

Study type: Observational

Funder types: Other

Identifiers

NCT05966714

20230509-z

Details and patient eligibility

About

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 establish reference value for each altitude level.

Enrollment: 531 patients

Sex: All

Ages: Under 72 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Singleton term infants (gestational age between 37 0/7 and 41 6/7 weeks) born in the participating hospital.
2. 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.
3. The mother is permanent residence of the current altitude level and live in the study area for the entire duration of pregnancy.

Exclusion criteria

1. Need for supplemental oxygen or assisted ventilation.
2. Any evidence of intrauterine distress such as meconium-stained amniotic fluid, Apgar score <7 at 1 or 5 min.
3. Referred to neonatal intensive care unit or neonatology department for any reason other than observation.
4. With major congenital anomaly.
5. Probes cannot be properly placed due to scalp lesions or hematomas.
6. Reject or withdraw from the study.

Trial design

531 participants in 2 patient groups

Group 1

Description:

Lijiang(2500m)

Treatment:

Device: aEEG

Group 2

Description:

Shangri-La (3500 m)

Treatment:

Device: aEEG