The Effects of SAFE Early Intervention Approach in Premature Infants in Turkey

Infant, Premature, Diseases Clinical Trial

— SAFE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889846
• Other study ID #: E-77082166-302.08.01-48434
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: November 2, 2021

Study information

• Verified date: November 2021
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2, 2021
• Est. primary completion date: October 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 10 Months

Eligibility

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).

Related Conditions & MeSH terms

• Infant, Premature, Diseases
• Premature Birth

Intervention

Procedure:
• SAFE 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.

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Health Sciences Department of Pyhsiotherapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

Hielkema T, Blauw-Hospers CH, Dirks T, Drijver-Messelink M, Bos AF, Hadders-Algra M. Does physiotherapeutic intervention affect motor outcome in high-risk infants? An approach combining a randomized controlled trial and process evaluation. Dev Med Child Neurol. 2011 Mar;53(3):e8-15. doi: 10.1111/j.1469-8749.2010.03876.x. — View 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. Review. — View 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. — View Citation

Pekçetin S, Aki E, Üstünyurt 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)	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.	10 weeks
Secondary	Hammersmith Infant Neurological Examination (HINE)	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).	10 weeks
Secondary	The Test of Sensory Functions in Infants (TSFI)	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.	10 weeks
Secondary	Canadian Occupational Performance Measure (COPM)	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.	10 weeks
Secondary	Affordances in the Home Environment for Motor Development - Infant Scale (AHEMD-IS)	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.	10 weeks
Secondary	The Depression, Anxiety and Stress Scales-Short Form (DASS-21)	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.	10 weeks