Neonatal Cerebral Oxygenation and Electrical Activity at Different Altitude Levels
- Conditions
- Altitude HypoxiaNeonatal Encephalopathy
- Registration Number
- NCT05966714
- Lead Sponsor
- Children's Hospital of Fudan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Singleton term infants (gestational age between 37 0/7 and 41 6/7 weeks) born in the<br> participating hospital.<br><br> 2. Infants appear well as defined by normal vital signs (heart rate ranging from 110 to<br> 180 beats/min, respiratory rate ranging from 30 to 60 breaths/min, temperature<br> ranging from 36.5°C to 37.5°C), absence of signs of illness such as cyanosis,<br> respiratory distress and heart murmur.<br><br> 3. The mother is permanent residence of the current altitude level and live in the<br> study area for the entire duration of pregnancy.<br><br>Exclusion Criteria:<br><br> 1. Need for supplemental oxygen or assisted ventilation.<br><br> 2. Any evidence of intrauterine distress such as meconium-stained amniotic fluid, Apgar<br> score <7 at 1 or 5 min.<br><br> 3. Referred to neonatal intensive care unit or neonatology department for any reason<br> other than observation.<br><br> 4. With major congenital anomaly.<br><br> 5. Probes cannot be properly placed due to scalp lesions or hematomas.<br><br> 6. Reject or withdraw from the study.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in cerebral oxygenation in neonates within three days after birth at different altitudes
- Secondary Outcome Measures
Name Time Method Differences in tissue oxygen extraction in neonates within three days after birth at different altitudes;Differences in cerebral fractional tissue oxygen extraction in neonates within three days after birth at different altitudes;Differences in aEEG indicators in neonates within three days after birth at different altitudes;Establish reference values for each altitude level