Randomized trial of a parenting intervention for very preterm infants: outcome at 2 years.

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, 3.2) or Psychomotor Development Index (2.5; -3.3, 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/> or =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.