Prophylactic aminophylline on renal function in term neonates with perinatal asphyxia: a randomized controlled trial
- Conditions
- All term infants with physiologic criteria of perinatal asphyxia will be enrolled who borned on January 2017 to January 2018perinatal asphyxia
- Registration Number
- TCTR20171219002
- Lead Sponsor
- Faculty of medicine Ramathibodi hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 40
All term infants with physiologic criteria of perinatal asphyxia will be enrolled who borned on January 2017 to January 2018
Perinatal asphyxia will have at least 1 to 3 condition:
1) blood gas from umbilical cord blood or blood gas at first hour of life have pH ≤ 7 or base deficit ≥ 16 mEq/L
2)blood gas from umbilical cord blood or blood gas at first hour of life have pH = 7.01-7.15 or base deficit 10-15.9 mEq/L
and have Acute Perinatal Event (1 of the following)
Late หรืภvariable decelerations
Cord prolapsed หรืภcord rupture
Uterine rupture
Maternal trauma หรืภhemorrhage
Cardiorespiratory arrest
and Apgar score at 10 min ≤ 5 or assisted ventilation needed beyond 10 min or seizure within 1 hour of life
3)if no blood gas:use criteria Acute Perinatal Event (1 of the following)
Late หรืภvariable decelerations
Cord prolapsed หรืภcord rupture
Uterine rupture
Maternal trauma หรืภhemorrhage
Cardiorespiratory arrest
and Apgar score at 10 min ≤ 5 or assisted ventilation needed beyond 10 min or seizure ภายใน 1 ชั่วโมงหลังเà¸à¸´à¸”
small for gestational age (SGA), KUB anomaly, polycythemia, chromosomal disorders, and parent of subject did not agreed or quit to study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate renal function in all asphyxiated infants who receiveseither TH or no TH within the f day 1 to day 5 of life serum creatinine
- Secondary Outcome Measures
Name Time Method To evaluate renal outcomes at 1 month old. day 28 of life serum creatinine,To evaluate metabolic disturbance, diuretic use and hospital stay. day 1 to day 5 of life serum electrolyte,To evaluate renal tubular function at first 5 days of life day 1 to day 5 of life urine beta2 microglobulin