Lisbeth Hauglann1, Bjørn Helge Handegaard2, Stein Erik Ulvund3, Marianne Nordhov4, John A Rønning5, Per Ivar Kaaresen4. 1. Division of Child and Adolescent Health, Department of Child and Adolescent Psychiatry, University Hospital of North Norway, Tromsø, Norway. 2. Regional Centre for Child and Youth Mental Health and Child Welfare, The Arctic University of Norway, Tromsø, Norway. 3. Regional Centre for Child and Youth Mental Health and Child Welfare, The Arctic University of Norway, Tromsø, Norway Department of Educational Research, University of Oslo, Oslo, Norway. 4. Pediatric Department, University Hospital of North Norway, Tromsø, Norway Pediatric Research Group, Faculty of Health Sciences, The Arctic University of Norway, Tromsø, Norway. 5. Pediatric Research Group, Faculty of Health Sciences, The Arctic University of Norway, Tromsø, Norway.
Abstract
OBJECTIVE: Examine the effect of an early intervention programme on cognitive outcome at 7 and 9 years in children with birth weight (BW) <2000 g. DESIGN: A randomised controlled trial of a modified version of the Mother-Infant Transaction Program. SETTING: A single tertiary neonatal unit. PATIENTS: 146 infants were randomised into a preterm control group (74) or a preterm intervention group (72). INTERVENTIONS: The intervention consisted of eight sessions shortly before discharge and four home visits by specially trained nurses focusing on the infants' unique characteristics, temperament, developmental potential and the interaction between infants and parents. MAIN OUTCOME MEASURES: Outcomes were assessed with the Wechsler Intelligence Scale for Children (WISC-III). RESULTS: Mean BWs were 1396 (429) g in the intervention group and 1381(436) g in the control group. After adjusting for the possible clustering effects of twin pairs and maternal education, there were no significant differences in WISC-III scores at age 7 or 9. The mean difference was 4.1 points (95% CI -1.5 to 9.8 points) in favour of the intervention group at 7 years and 2.2 points (95% CI -3.4 to 7.6 points) at 9 years. At 7 years, a 6.8 points difference in the Verbal Comprehension Index (95% CI 0.5 to 13.0 points) was found in favour of the intervention group. Loss to follow-up at age 7 and 9 was 11% and 14%, respectively. CONCLUSIONS: This intervention programme did not have a sustained significant effect on overall cognitive outcomes in preterm children at age 7 and 9. TRIAL REGISTRATION NUMBER: The trial has been registered at http://www.clinicaltrials.gov (identifier NCT00222456). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
OBJECTIVE: Examine the effect of an early intervention programme on cognitive outcome at 7 and 9 years in children with birth weight (BW) <2000 g. DESIGN: A randomised controlled trial of a modified version of the Mother-Infant Transaction Program. SETTING: A single tertiary neonatal unit. PATIENTS: 146 infants were randomised into a preterm control group (74) or a preterm intervention group (72). INTERVENTIONS: The intervention consisted of eight sessions shortly before discharge and four home visits by specially trained nurses focusing on the infants' unique characteristics, temperament, developmental potential and the interaction between infants and parents. MAIN OUTCOME MEASURES: Outcomes were assessed with the Wechsler Intelligence Scale for Children (WISC-III). RESULTS: Mean BWs were 1396 (429) g in the intervention group and 1381(436) g in the control group. After adjusting for the possible clustering effects of twin pairs and maternal education, there were no significant differences in WISC-III scores at age 7 or 9. The mean difference was 4.1 points (95% CI -1.5 to 9.8 points) in favour of the intervention group at 7 years and 2.2 points (95% CI -3.4 to 7.6 points) at 9 years. At 7 years, a 6.8 points difference in the Verbal Comprehension Index (95% CI 0.5 to 13.0 points) was found in favour of the intervention group. Loss to follow-up at age 7 and 9 was 11% and 14%, respectively. CONCLUSIONS: This intervention programme did not have a sustained significant effect on overall cognitive outcomes in preterm children at age 7 and 9. TRIAL REGISTRATION NUMBER: The trial has been registered at http://www.clinicaltrials.gov (identifier NCT00222456). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Entities:
Keywords:
Child Psychology; Neurodevelopment; Outcomes research