Clinical trial NCT04889846: The Effects of SAFE Early Intervention Approach in Premature Infants in Turkey
Official title: Investigation of the Effectiveness of Family Collaborative Early Intervention Approach Based on Sensory Strategies, Activity Based Motor Training and Environmental Enrichment in Premature Infants: SAFE National Early Intervention Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 24
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind randomised controlled trial
Primary purpose: TREATMENT

Brief summary: In this study, it was aimed to develop the SAFE treatment approach, which is a family collaborative early intervention approach based on sensory strategies, activity-based motor training and environmental enrichment, and to examine the effects of this approach on sensory, motor, cognitive and language development in premature infants.

Detailed description: Early intervention practices in Turkey is widely based on the principle of neuro-developmental therapy (NDT). It has been reported in recent years that the NDT approach has minimal effect on the development of risky premature infants. For these reasons, it was necessary to develop an early intervention program that does not include passive interventions and includes sensory and motor strategies in our country.

Within the scope of this study, a new early intervention approach that can be applied to infants between 0-24 months has been developed based on the shortcomings in the literature. Sensory strategies, activity-based motor training, family collaboration and environmental enrichment constitute the basic principles of this early intervention program. The name of the early intervention program was formed from the English initials of these basic principles and was determined as SAFE early intervention approach (S: Sensory Strategies, A: Activity Based Motor Training, F: Family Collaboration, E: Environmental Enrichment).

In this study, it was planned to establish the theoretical and practical foundations of the SAFE early intervention approach developed by the Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Also we aimed to examine the effects of this approach on sensory, motor, cognitive and language development in preterm infants with corrected ages of 9-10 months.

Eligibility criteria: Inclusion Criteria:

* Being born before 37 weeks
* A history of Neonatal Intensive Care Unit (NICU) for 15 days or more
* Adjusted age to be between 9-10 months
* Family's willingness to participate in the study

Exclusion Criteria:

* Having a congenital anomaly or systemic disease
* Having a high risk for the diagnosis of Cerebral Palsy (Intraventriculer hemorrhage (IVH) Stage 4 or periventricular leukomalacia (PVL) Stage 3-4, such as the absence of fidgety movements).

Primary outcomes:
measure: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
timeFrame: 10 weeks
Secondary outcomes:
measure: Hammersmith Infant Neurological Examination (HINE)
timeFrame: 10 weeks
measure: The Test of Sensory Functions in Infants (TSFI)
timeFrame: 10 weeks
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 10 weeks
measure: Affordances in the Home Environment for Motor Development - Infant Scale (AHEMD-IS)
timeFrame: 10 weeks
measure: The Depression, Anxiety and Stress Scales-Short Form (DASS-21)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Pyhsiotherapy and Rehabilitation
Study officials:
affiliation: Gazi University Faculty of Health Sciences
name: Bülent Elbasan, Prof
role: STUDY_DIRECTOR
References:
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citation: Morgan C, Novak I, Badawi N. Enriched environments and motor outcomes in cerebral palsy: systematic review and meta-analysis. Pediatrics. 2013 Sep;132(3):e735-46. doi: 10.1542/peds.2012-3985. Epub 2013 Aug 19.
citation: Morgan C, Novak I, Dale RC, Guzzetta A, Badawi N. Single blind randomised controlled trial of GAME (Goals - Activity - Motor Enrichment) in infants at high risk of cerebral palsy. Res Dev Disabil. 2016 Aug;55:256-67. doi: 10.1016/j.ridd.2016.04.005. Epub 2016 May 7.
citation: Dusing SC, Burnsed JC, Brown SE, Harper AD, Hendricks-Munoz KD, Stevenson RD, Thacker LR, Molinini RM. Efficacy of Supporting Play Exploration and Early Development Intervention in the First Months of Life for Infants Born Very Preterm: 3-Arm Randomized Clinical Trial Protocol. Phys Ther. 2020 Aug 12;100(8):1343-1352. doi: 10.1093/ptj/pzaa077.
citation: Pekcetin S, Aki E, Ustunyurt Z, Kayihan H. The Efficiency of Sensory Integration Interventions in Preterm Infants. Percept Mot Skills. 2016 Oct;123(2):411-23. doi: 10.1177/0031512516662895. Epub 2016 Aug 10.