Infant, Premature, Diseases
Conditions
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.
Interventions
PROCEDURESAFE early intervention approach
SAFE approach is a national early intervention approach which is based on sensory strategies, activity based motor training, family collaboration and environmental enrichment.
Sponsors
Gazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single blind randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
9 Months to 10 Months
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) | 10 weeks | Bayley-III is a widely used test battery to assess cognitive, receptive and expressive language, gross and fine motor development in children aged 1 to 42 months. The items in each section are scored as 1 (can do the desired skill) and 0 (cannot do the desired skill). The raw scores obtained from all items are converted into scale points ranging from 1 to 19 points. Then, a composite score is obtained according to this scale score. It is the composite score commonly used in studies. Composite scores range from 40 to 160. The higher the score, the better the improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hammersmith Infant Neurological Examination (HINE) | 10 weeks | HINE is an easy-to-apply, standardized and scorable test used for clinical neurological evaluation of babies aged 2-24 months. The test consists of 3 parts. The first part is the scoring neurological examination section, which consists of 26 items that evaluate cranial nerve function, posture, movements, tone, reflexes and reactions. The second section is the motor milestones section and consists of 8 items that cannot be scored. The third part is the behavior section that cannot be scored and consists of 3 items. The first 26-item section can be scored as 0,1,2,3. The total score that can be obtained in HINE is 78. While the optimal score for 9-12 month infants is 73, this score is 70 for 6 month infants. Scores below 57 points per month indicate a great risk for the diagnosis of Cerebral Palsy (CP). |
| The Test of Sensory Functions in Infants (TSFI) | 10 weeks | TSFI evaluates sensory processing and reactivity in infants aged 4-18 months. TSFI consists of 5 subtests: response to tactile deep pressure, adaptive motor response, visual-tactile integration, oculo-motor test, and response to vestibular stimulation. All subtests consist of a total of 24 items. The total score ranges from 0 to 49. In 10-12 month-old infants, a score between 44-49 indicates good sensory function, 41-43 points indicate risky status, 0-40 points indicate sensory processing problem. |
| Canadian Occupational Performance Measure (COPM) | 10 weeks | Secondary outcomes included the COPM an individualised criterion-referenced measure of performance and satisfaction with performance of a parent-selected range of activities. In this study COPM was used at baseline to prioritise parent goals for their infants development and assess parents perception of their infants performance on identified goals and their own satisfaction with the infants current ability. |
| Affordances in the Home Environment for Motor Development - Infant Scale (AHEMD-IS) | 10 weeks | Enrichment of the home environment was assessed with the AHEMD-IS. AHEMD-IS identifies opportunities available within the home to promote motor development, including characteristics of the indoor and outdoor environment and the presence of a range of toys and equipment. Total score possible for infants younger than 11 months is 66 while from 12 months possible total score is 93, to account for the expected increase in available learning materials. |
| The Depression, Anxiety and Stress Scales-Short Form (DASS-21) | 10 weeks | DASS-21 is a questionnaire that evaluates the depression, anxiety and stress states of individuals. DASS-21 is a 21-item assessment tool developed from the 42-item long form of the scale. DASS-21 is specified as an easily applicable and low-cost scale. It has been shown to be effective in detecting patients with depressive and anxiety disorders. |
Countries
Turkey (Türkiye)
Outcome results
None listed