All term infants with physiologic criteria of perinatal asphyxia will be enrolled who borned on January 2017 to January 2018 perinatal asphyxia
Conditions
Interventions
All enrolled infants will be randomized to a single dose of intravenous aminophylline 8 mg/kg or placebo within the first hour of life.
Renal function will be accessed by serum creatinine,
GFR,
urine output and urine beta2 microglobulin during the first 5 days. At 1 month old,
renal function will be evaluated.
Experimental Drug
Aminophylline
Sponsors
Faculty of medicine Ramathibodi hospital
Division of Neonatology
Eligibility
Sex/Gender
All
Age
1 Years to 1 Hours
Inclusion criteria
Inclusion criteria: 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¸”
Exclusion criteria
Exclusion criteria: small for gestational age (SGA), KUB anomaly, polycythemia, chromosomal disorders, and parent of subject did not agreed or quit to study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactKiengkwan Amphaiphan
Faculty of Pediatric Ramathibodi hospital, division of neonatology
Outcome results
None listed