Original ArticleRandomized Trial of a Parenting Intervention for Very Preterm Infants: Outcome at 2 Years
Section snippets
Methods
The study design (ISRCTN56341521) has been described in detail previously.14 Briefly, a cluster-randomized, controlled trial with a cross-over design was conducted in 6 neonatal centers (incorporating 7 NICUs) in 2 regions of the United Kingdom (3 each in the South West and Trent regions). Approval was obtained from the South West multi-center ethics committee and the local research ethics committees at each center. Within regions, 2 centers were paired on the basis of deprivation indices, and
Results
The derivation of this cohort has been described previously.14 Of 496 babies born at <32 weeks at participating centers, 156 were excluded and 33 died before obtaining consent. Of the remaining 307 babies, 233 (76%) were recruited to the study: 112 (81% of those eligible) to the intervention group and 121 (72% of those eligible) to the control. There were no significant differences in sex, birth weight, gestational age and multiple births between babies who were and were not recruited to the
Discussion
In this rigorous randomized, controlled trial, there was no significant effect of the PBIP16 on cognitive development at 2 years' corrected age in very preterm infants. This result is perhaps not entirely unexpected because trials investigating the efficacy of parenting interventions for very preterm infants have generally produced variable and conflicting results. Although some studies have reported beneficial effects of intervention on cognitive outcomes,11, 12, 21 others have failed to
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Cited by (0)
Supported by the Health Foundation, London, United Kingdom
The authors have no conflicts of interest to declare.