Multicentre prospective randomised single-blind controlled study protocol of the effect of an additional

Karine Pelc1,2, Irit Daniel2, Bernard Wenderickx2

  • 1Department of Paediatrics, Centre Hospitalier Universitaire Saint-Pierre, Université libre de Bruxelles (ULB), Brussels, Belgium.

BMJ Open
|December 6, 2017
PubMed

Insights

This study evaluates a parent-led stimulation program for preterm infants to improve neurodevelopment. The intervention aims to optimize motor and neurophysiological outcomes in high-risk newborns.

Area of Science:

  • Neonatology
  • Developmental Neuroscience
  • Pediatric Rehabilitation

Background:

  • Preterm and very low birthweight infants face elevated risks for neurodevelopmental disorders.
  • Early interventions are crucial for optimizing neurological development in these vulnerable infants.
  • Interventions should consider parental mental health, parent-child interaction, and duration.

Purpose of the Study:

  • To evaluate the effects of a parent-administered stimulation program on preterm infants' motor and neurophysiological development.
  • To assess the impact of the intervention from 37 weeks' gestation to 6 months' corrected age.
  • To investigate the long-term neurodevelopmental outcomes up to 24 months' corrected age.

Main Methods:

  • Randomized controlled trial involving infants born <32 weeks' gestation or <1500g.
  • Intervention group received a stimulation program; control group received standard follow-up.
  • Data collection included perinatal, clinical, neuroimaging, Bayley Scales of Infant Development, Parental Stress Index, and high-density EEG.

Main Results:

  • (Pre-results: Study ongoing)
  • Analysis will focus on spatiotemporal frequency bands and source localization from EEG data.
  • Neurodevelopmental assessments and parental stress will be tracked over 24 months corrected age.

Conclusions:

  • The study will provide insights into the efficacy of parent-led early intervention for preterm infants.
  • Findings may inform clinical practice and policy for optimizing neurodevelopmental outcomes.
  • Results will be disseminated to stakeholders, families, healthcare providers, and policymakers.
Abstract

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