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Effect of child development centre model early stimulation among at risk babies -- a randomized controlled trial [with consumer summary]
Nair MKC, Philip E, Jeyaseelan L, George B, Mathews S, Padma K
Indian Pediatrics 2009 Jan;46(Suppl):s20-s26
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To study the effectiveness of child development centre (CDC) model early stimulation therapy done in the first year of postnatal life, in improving the developmental outcome of at-risk neonates at one and two years of age. DESIGN: Randomized controlled trial. SETTING AND SUBJECTS: The study participants included a consecutive sample of 800 babies discharged alive from the level II nursery of Medical College, Thiruvananthapuram. INTERVENTION: The control group received routine postnatal check-up as per hospital practice. Intervention group in addition received CDC model early stimulation therapy (home-based). RESULTS: The intervention group of babies had a statistically significant higher score for mental developmental index (MDI) and psychomotor developmental index (PDI) at one and two years of age. After adjusting all significant risk factors for development, the babies who had intervention had significantly higher Bayley scores, 5.8 units at one year and 2.8 units at two year, as compared to control babies. CONCLUSION: Early stimulation therapy was effective at one year. The beneficial effect also persisted at two years, without any additional interventions in the second year.

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