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Thirteen-year outcomes of a randomized clinical trial of early preventive care for very preterm infants and their parents
Stedall PM, Spencer-Smith MM, Mainzer RM, Treyvaud K, Burnett AC, Doyle LW, Spittle AJ, Anderson PJ
The Journal of Pediatrics 2022 Jul;246:80.e84-88.e84
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; 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*

OBJECTIVES: To evaluate 13-year outcomes of a randomized controlled trial of preventive care (VIBeS Plus) for infants born very preterm and their parents, and whether effects of intervention varied by family social risk. STUDY DESIGN: Families were randomized to intervention (n = 61) or standard care (n = 59). The intervention was delivered at home by psychologists and physiotherapists over the infants' first year, focusing on infant development and parental mental health. At 13-years' corrected age, cognitive, motor, and behavioral outcomes, and parental mental health were assessed. Primary estimands were between-group mean differences (MDs), estimated using multiple imputed regression models. RESULTS: Follow-up included 81 (69%) surviving children. There was little evidence for intervention benefits for IQ, attention, and executive function, working memory, and academic skills, regardless of level of social risk. Specifically, MDs in adolescent cognitive outcomes ranged from -2.0 units (95% CI -9.9 to 5.9) in favor of standard treatment to 5.1 (-2.3 to 12.5) units favoring the intervention. A group-by-social risk interaction was observed only for adolescent motor outcomes, with MDs favoring the intervention for those at higher social risk (balance: 4.9 (95% CI 1.3 to 8.5); total motor: 3.2 (95% CI 0.3 to 6.2)), but not those at lower social risk (balance: -0.3 (95% CI -2.4 to 1.9), total motor: 0.03 (95% CI -1.9 to 2.0)). MDs in adolescent behavior and parental mental health ranged from -6.6 (95% CI -13.8 to 0.5) to -0.2 (95% CI -1.9 to 1.4) and -1.8 (95% CI -4.1 to 0.6) to -1.7 (95% CI -4.3 to 1.0), respectively, indicating a pattern of fewer symptoms in the intervention group. CONCLUSIONS: Intervention benefits persist for adolescent behavior, with better motor outcomes observed in those from socially disadvantaged families. Replication with larger samples, multiple informant-report, and assessment of quality of life-related outcomes are warranted.

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