Ghazi S, Sadeghi Z, Soleimani F, Lessen Knoll B, Darui A, Abdollahi I et al . Impact of Premature Infant Oral Motor Intervention on Swallowing Muscle Activity and Developmental Outcomes: A Study Protocol. J. Pediatr. Rev 2026; 14 (3) :309-318
URL:
http://jpr.mazums.ac.ir/article-1-796-en.html
1- Department of Speech Therapy, Faculty of Rehabilitation Sciences, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.
2- Department of Speech Therapy, Faculty of Rehabilitation Sciences, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. , zah.sadeghi@uswr.ac.ir
3- Pediatric Neurorehabilitation Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.
4- Department of Nursing, Illinois Wesleyan University, Bloomington, United States of America.
5- Department of Physiotherapy, Faculty of Rehabilitation Sciences, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.
6- Department of Biostatistics and Epidemiology, Faculty of Rehabilitation Sciences, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.
Abstract: (18 Views)
Background: Motor control in infancy begins with feeding and swallowing, which can affect later cognitive, language, social-communication, and motor development. Feeding disorders in preterm infants increase the risk of developmental delays. The premature infant oral motor intervention (PIOMI) is a structured method developed to enhance oral feeding in preterm infants, but its effects on swallowing muscle activity and long-term developmental outcomes remain unclear.
Objectives: This study provides a protocol for a randomized controlled trial (RCT) that will evaluate the impact of PIOMI on swallowing muscle activity and developmental outcomes in preterm infants with feeding disorders.
Methods: This is a protocol for a single-blind RCT with a pre-test/post-test/follow-up design, with the participation of 60 preterm infants with feeding disorders from the neonatal intensive care unit (NICU) of a medical center in Babol, Iran. They will be randomly allocated to the PIOMI and control groups. The PIOMI group will receive daily oral-motor intervention for seven days along with routine care, while the control group will receive only routine care. Swallowing muscle activity will be assessed using surface electromyography (sEMG) pre- and post-intervention. Developmental outcomes, including cognitive, receptive/expressive language, social-communication, and motor skills, will be evaluated at 3 and 6 months post-intervention using the Newsha development scale, the ages and stages questionnaire, third edition (ASQ-3), and the Bayley scales of infant and toddler development, third edition (Bayley-III).
Results: Recruitment began in April 2025, and the intervention and follow-up are expected to conclude in December 2025. The results of data analysis will be ready by summer 2026.
Conclusions: We assume that PIOMI may enhance developmental outcomes, support independent oral feeding, and improve long-term developmental outcomes in preterm infants. Findings of the RCT are expected to inform clinical practice and standards of NICU care.
Type of Study:
Protocol |
Subject:
Pediatrics Received: 2025/09/14 | Accepted: 2026/05/12 | Published: 2026/09/19