OBJECTIVES: To determine the efficacy of a neonatal parenting intervention for improving development in very preterm infants. STUDY DESIGN: A cluster-randomized, controlled trial with a cross-over design and washout period was conducted in 6 neonatal centers. Two hundred thirty-three babies < 32 weeks' gestation were recruited (intervention = 112; control = 121). Intervention families received weekly Parent Baby Interaction Programme (PBIP) sessions during neonatal intensive care unit admission and up to 6 weeks after discharge. Control families received standard care. All 195 infants remaining in the study at 24 months' corrected age were assessed by psychologists blinded to group allocation. RESULTS: There was no significant difference in Mental Development Index (-0.9 points; 95% CI -5.0 to 3.2) or Psychomotor Development Index (2.5; -3.3 to 8.4) scores between the intervention and control groups and no significant effect of intervention on Mental Development Index or Psychomotor Development Index scores for subgroups dichotomized by gestational age (< 28 weeks, >= 28 weeks), parity (1st, other child) or mother's cohabiting status (supported, unsupported). CONCLUSIONS: There was no effect of PBIP on infant development at 2 years' corrected age. Parenting interventions may be better delivered after discharge or targeted for preterm infants with high biological and social risk.

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