Pyritinol for post asphyxial encephalopathy in term babies-- a randomized double-blind controlled trial.
OBJECTIVE
To evaluate the efficacy of pyritinol in improving the neurodevelopmental outcome at one year of age among term babies with post-asphyxial encephalopathy.


METHODS
Level II Neonatal Nursery and Child Development Centre, Medical College, Thiruvananthapuram.


METHODS
Randomised placebo controlled double blind trial.


METHODS
108 term babies with post-asphyxial encephalopathy, stratified into three grades based on clinical criteria.


METHODS
The treatment group (n=54) received pyritinol and the control group (n=54) received placebo, in exactly the same increasing dosage schedule of 1 to 5 mL liquid drug (20-100 mg) from 8th postnatal day until the end of six months.


METHODS
Mean Mental Development Index (MDI) and mean Psychomotor Development Index (PDI) measured on Bayley Scales of Infant Development at one year of age.


RESULTS
No statistically significant difference was observed in MDI or PDI scores at one year between the treatment and control groups. The confidence interval for the differences ranged from -6.3 to 8.7 for MDI and from - 4.1 to 12.7 for PDI. On multiple regression analysis using one year MDI and PDI scores, even after controlling for birthweight, there was no statistically significant difference between the treatment and control groups.


CONCLUSIONS
Pyritinol is not useful in improving the neurodevelopmental status of babies with post-asphyxial encephalopathy at one year of age.
Nair
M K C
MK
Child Development Centre, Medical College, Thiruvananthapuram, Kerala, India. nairmkc@rediffmail.com
George
Babu
B
Jeyaseelan
L
L
D001238:Asphyxia Neonatorum / Q000150:complications*; D002657:Child Development; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D002534:Hypoxia, Brain / Q000188:drug therapy* / Q000209:etiology; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011746:Pyrithioxin / Q000627:therapeutic use*; D047929:Term Birth; D017211:Treatment Failure
D011746:Pyrithioxin