EARLY PHYSIOTHERAPY INTERVENTION IN PRETERM INFANTS: A RANDOMIZED CONTROLLED TRIAL PILOT STUDY

Ochandorena-Acha M1,2, Casas-Baroy JC1,2, Terradas-Monllor M3, Agut-Quijano T4, Cazorla-Sanchez ME4, Iriondo-Sanz M4, Gómara-Toldrà N5
1University of Vic - Central University of Catalonia, Faculty of Health Science and Welfare, Vic, Spain, 2Research Group Methodology, Methods, Models of Health and Social Outcomes (M3O), Vic, Spain, 3University of Barcelona, Barcelona, Spain, 4Hospital Sant Joan de Déu, Neonatology Department, Barcelona, Spain, 5School of Health Science Blanquerna, Ramon Llull University, Barcelona, Spain

Background: Preterm infants are children with high biological risks for developmental delay, such as: motor, cognitive, learning and behavioural problems. In addition, these alterations have a considerable impact on the family and society. Early physiotherapy intervention aims to improve and/or prevent the negative consequences, and favour the motor development and infants' functionality, as well as the mother-child interaction.

Purpose: The purpose of this randomized controlled trial pilot study was to evaluate the initial short-term efficacy of early and multimodal physiotherapy intervention to improve motor development, and decrease the risk of developmental delay of preterm infants and mothers' stress degree.

Methods: 20 preterm infants were recruited, with a gestational age between 28 and 34 weeks, admitted to the Neonatal Intensive Care Unit (NICU) of the Hospital Sant Joan de Déu, Barcelona (Spain). Exclusion criteria included: infants with neonatal diagnosis of a brain injury or a congenital disease, a diagnosis of a genetic syndrome or musculoskeletal deformity or major surgery. The infants were randomized either to the intervention group (IG) which received the early multimodal physiotherapy intervention in addition to the usual care, or the control group (CG) which received only the usual care. No infants had to be excluded (IG; n= 10; CG n= 10).
The early multimodal physiotherapy intervention is divided in three parts: firstly, parent education sessions, to empower them on infant development. Secondly, tactile and kinesthetic stimulation managed by parents. These two were performed during the stay at the NICU. Thirdly, home psychomotor development program for the baby, started at 40 weeks postmenstrual age (PMA) until 1 month of corrected age. Primary patient-outcomes were development and risk of development delay, evaluated with the General Movement Assessment (GMA) and The Ages and Stages Questionnaires Third Edition (ASQ-3), measured at 40 weeks PMA and 1 month of corrected age, respectively. Secondary outcome measures were mothers' stress index regarding her role as a main carer, evaluated with the Spanish adaptation of the scale Parent Stress Index - Short Form (PSI-SF). Data were analysed using a descriptive analysis of the baseline data, and comparison of means for the outcome variables.

Results: No differences were observed between groups at baseline. At 1 month of corrected age, the ASQ-3 showed statistically significant differences between groups (p 0,05) in communication, fine motor, problem solving and socio-individual areas. Within group analyses IG showed a higher score in these four domains. However, between groups no differences were observed in the gross motor domain neither regarding GMA and PSI-SF evaluations.

Conclusion(s): While further research is needed, this pilot study showed promising short-term results for the effectiveness of early multimodal physiotherapy intervention to improve preterm infant development at 1 month of corrected age. Nevertheless, there were no differences in gross motor development between groups.

Implications: This is the first study that examined the effectiveness of early physiotherapy intervention that includes intervention for the premature infant and for the parents, which starts in the NICU and has continuity at home. Broad implementation of this physiotherapy intervention might have huge effects on preterm infant development.

Keywords: early physiotherapy intervention, preterm infant, neonatal intensive care unit

Funding acknowledgements: This work was not funded.

Topic: Paediatrics

Ethics approval required: Yes
Institution: Clinical Research Ethics Committee Fundación Sant Joan de Déu (Barcelona)
Ethics committee: Clinical Research Ethics Committee Fundación Sant Joan de Déu (Barcelona)
Ethics number: PIC-139-17


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