Perioperative risk factors were inconsistently associated with developmental outcomes .
INTERPRETATION The literature on children undergoing surgery in early infancy suggests that infants with a single ventricle are at highest risk of adverse developmental outcomes .
WHAT THIS PAPER ADDS Children with complex congenital heart disease ( CHD ) are at increased risk of impaired developmental outcome .
Children with single-ventricle CHD have worse outcomes than children with two-ventricle CHD .
Children with two-ventricle CHD gradually grow out of their initial developmental impairment .
Perioperative factors are inconsistently associated with outcome
AIM ( 1 ) To systematic ally review the literature on developmental outcomes from infancy to adolescence of children with complex congenital heart disease ( CHD ) who underwent early surgery ; ( 2 ) to run a meta-regression analysis on the Bayley Scales of Infant Development , Second Edition Mental Developmental Index and Psychomotor Developmental Index ( PDI ) of infants up to 24 months and IQs of preschool-aged children to adolescents ; ( 3 ) to assess associations between perioperative risk factors and outcomes .
Erythropoietin neuroprotection in neonatal cardiac surgery: a phase I/II safety and efficacy trial.
OBJECTIVES Neonates undergoing complex congenital heart surgery have a significant incidence of neurologic problems . Erythropoietin has antiapoptotic , antiexcitatory , and anti-inflammatory properties to prevent neuronal cell death in animal models , and improves neurodevelopmental outcomes in full-term neonates with hypoxic ischemic encephalopathy . We design ed a prospect i ve phase I/II trial of erythropoietin neuroprotection in neonatal cardiac surgery to assess safety and indicate efficacy . METHODS Neonates undergoing surgery for D-transposition of the great vessels , hypoplastic left heart syndrome , or aortic arch reconstruction were r and omized to 3 perioperative doses of erythropoietin or placebo . Neurodevelopmental testing using the Bayley Scales of Infant and Toddler Development III was performed at age 12 months . RESULTS Fifty-nine patients received the study drug . Safety profile , including magnetic resonance imaging brain injury , clinical events , and death , was not different between groups . Three patients in each group died . Forty-two patients ( 22 in the erythropoietin group and 20 in the placebo group ; 79 % of survivors ) returned for 12-month follow-up . In the group receiving erythropoietin , mean Cognitive Scale scores were 101.1 ± 13.6 , Language Scale scores were 88.5 ± 12.8 , and Motor Scale scores were 89.9 ± 12.3 . In the group receiving placebo  , Cognitive Scale scores were 106.3 ± 10.8 ( P = .19 ) , Language Scores were 92.4 ± 12.4 ( P = .33 ) , and Motor Scale scores were 92.6 ± 14.1 ( P = .51 ) . CONCLUSIONS Safety profile for erythropoietin administration was not different than placebo . Neurodevelopmental outcomes were not different between groups ; however , this pilot study was not powered to definitively address this outcome . Lessons learned suggest optimized study design features for a larger prospect i ve trial to definitively address the utility of erythropoietin for neuroprotection in this population
Perioperative risk factors were inconsistently associated with developmental outcomes .
INTERPRETATION The literature on children undergoing surgery in early infancy suggests that infants with a single ventricle are at highest risk of adverse developmental outcomes .
WHAT THIS PAPER ADDS Children with complex congenital heart disease ( CHD ) are at increased risk of impaired developmental outcome .
Children with single-ventricle CHD have worse outcomes than children with two-ventricle CHD .
Children with two-ventricle CHD gradually grow out of their initial developmental impairment .
Perioperative factors are inconsistently associated with outcome
AIM ( 1 ) To systematic ally review the literature on developmental outcomes from infancy to adolescence of children with complex congenital heart disease ( CHD ) who underwent early surgery ; ( 2 ) to run a meta-regression analysis on the Bayley Scales of Infant Development , Second Edition Mental Developmental Index and Psychomotor Developmental Index ( PDI ) of infants up to 24 months and IQs of preschool-aged children to adolescents ; ( 3 ) to assess associations between perioperative risk factors and outcomes .