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

NCT04889846 | Completed

• 1 other identifier: E-77082166-302.08.01-48434
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature, Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Hammersmith Infant Neurological Examination (HINE)

  10 weeks

• The Test of Sensory Functions in Infants (TSFI)

  10 weeks

• Canadian Occupational Performance Measure (COPM)

  10 weeks

• Affordances in the Home Environment for Motor Development - Infant Scale (AHEMD-IS)

  10 weeks

• The Depression, Anxiety and Stress Scales-Short Form (DASS-21)

  10 weeks

Study Arms (2)

SAFE early intervention group

EXPERIMENTAL

A family collaborative treatment program based on sensory strategies, activity-based motor training and environmental enrichment principles was created for the infants in the treatment group. Within the scope of the SAFE treatment approach, appropriate activities were explained to the families. Families were asked to do these activities every day for 10 weeks. The compliance of the families with the program was monitored every week via phone calls or the WhatsApp phone program. In addition, families were asked to keep a diary and note the duration of the activity. The homes of the families in the treatment group were visited at least once. During this visit, home environment was evaluated. In order to create an enriched home environment, families were informed about the toys and materials that can be obtained. The family's questions about the program were answered.

Procedure: SAFE early intervention approach

Control group

EXPERIMENTAL

Within the scope of this study, the infants in the control group were given an NDT-based family training program in accordance with their corrected months and current functional levels. In this context, appropriate activities were taught to families. Families were asked to do these activities every day for 10 weeks. The compliance of the families with the program was monitored every week via phone calls or the WhatsApp phone program. In addition, families were asked to keep a diary and note the duration of the activity. One visit was made to the homes of the families in the control group. The family's questions about the program were answered.

Procedure: SAFE early intervention approach

Interventions

SAFE early intervention approach PROCEDURE

SAFE approach is a national early intervention approach which is based on sensory strategies, activity based motor training, family collaboration and environmental enrichment.

Control group; SAFE early intervention group

Eligibility Criteria

• Age: 9 Months - 10 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Health Sciences Department of Pyhsiotherapy and Rehabilitation

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 21291457 BACKGROUND

• 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.

  PMID: 23958771 BACKGROUND

• 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.

  PMID: 27164480 BACKGROUND

• 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.

  PMID: 32329778 BACKGROUND

• 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.

  PMID: 27511923 BACKGROUND

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bülent Elbasan, Prof

  Gazi University Faculty of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant, PhD, PT.

Model Details: Single blind randomised controlled trial

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 17, 2021
• Study Start: October 15, 2019
• Primary Completion: October 17, 2021
• Study Completion: November 2, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)