Efficacy of the Small Step Program in a Randomized Controlled Trial for Infants under 12 Months Old at Risk of...

Area of Science:

• Pediatrics
• Developmental Pediatrics
• Neuroscience

Background:

• Infants at risk for cerebral palsy (CP) or neurodevelopmental disorders require early intervention.
• The Small Step Program is a novel intervention designed to enhance development in at-risk infants.
• Standard care provides a baseline for comparison in evaluating new therapeutic programs.

Purpose of the Study:

• To evaluate the efficacy of the Small Step Program compared to Standard Care.
• To assess the impact of the intervention on the general development of infants at risk for neurodevelopmental disorders.
• To determine if the Small Step Program aids in catching up developmental delays.

Main Methods:

• A randomized controlled trial was conducted with infants aged 4-9 months corrected age (CA).
• The intervention group received the 35-week Small Step Program, while the control group received Standard Care.
• The Peabody Developmental Motor Scales (PDMS-2) was the primary outcome measure, with follow-up at 2 years using PDMS-2 and PEDI mobility scale.

Main Results:

• No overall group effect was found on the PDMS-2 at the end of treatment.
• A significant interaction between group and baseline PDMS-2 scores was observed (p < 0.02).
• Infants in the Small Step group developed independently of their baseline scores, indicating a catch-up effect, particularly for more affected children. This was sustained at 2 years.

Conclusions:

• The Small Step Program demonstrates potential in helping infants at risk for neurodevelopmental disorders, especially those with greater initial delays.
• Early intervention through programs like Small Step may mitigate developmental deficits in at-risk populations.
• Long-term follow-up confirms sustained benefits in motor and mobility outcomes.