Examination of the Relationship Between Home Affordances With Development

Preterm Birth Clinical Trial

Official title:

Examination of the Relationship Between Home Affordances With Motor Development and Sensory Processing in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05210985
• Other study ID #: Home affordances
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: December 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Babies with a history of premature birth and low birth weight are at risk for developmental disorders. These infants may have motor, cognitive and behavioral problems compared to their term peers. Although advances in technology lead to an increase in survival rate, 50% of these infants may have developmental delays in motor, cognitive and behavioral areas. Premature birth does not accelerate any of the early sensory development processes, but exposure to intense, unusual stimuli of unusual character may delay or inhibit sensory development. Therefore, children born prematurely may be at risk in terms of sensory processing. The physical, sensory and social environment of the infant and young child is critical in supporting the healthy and appropriate development of the brain and nerve-sensory systems.

Description:

A newborn baby reacts involuntarily or reflexively to its environment. During the first few years of life, through physical growth and learning experiences, the child learns to participate actively in the world. Motor skills and sensory experiences begin to develop after birth, and development continues as children grow. Having good motor control also helps children explore the world around them, which can help many other areas of development. There are many environmental and biological factors that affect motor development. Especially the home environment where the child spends most of his time is one of the key factors affecting motor development. The home environment is known to be a very important factor for motor development in infants. At the same time, the variety of equipment and environmental conditions help children provide different sensory experiences. Exploring the home environment can have important developmental implications, as it is common practice for physiotherapists to advise patients on home activities. Environmental factors can affect the motor development of preterm children as well as other developmental areas. The number of studies examining the effects of environmental factors on motor and sensory development in preterm infants is limited in the literature. This study was planned to examine whether there is a relationship between the environmental conditions and equipment variety and the motor and sensory development of the preterm child.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 18 Months

Eligibility

Inclusion Criteria: Fifty infants between 4-18 months with a history of premature birth and with the consent of their parents will be included in the study.

Exclusion Criteria:

Babies with chromosomal anomaly, serious congenital problems and whose parents are not willing to work will not be included in the study.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• Affordances in the Home Environment for Motor Development-Infant Scale
Affordances in the Home Environment for Motor Development-Infant Scale is a parent-filled assessment to determine the nature and amount of factors affecting infant motor skill development in the home environment, including the availability of toys, materials, and the availability of spaces.
• Peabody Developmental Motor Scales-2
Peabody Developmental Motor Scales | Second Edition (PDMS-2) combines in-depth assessment with training or remediation of gross and fine motor skills of children from birth through 5 years.
• Test Of Sensory Functions In Infants (Tsfi)
This test helps you identify infants with sensory integrative dysfunction-including those at risk for developing learning disabilities as they grow older. The TSFI provides objective criteria that allow you to determine whether, and to what extent, an infant has deficits in sensory functioning. Designed for use with children from 4 months to 18 months old, the TSFI provides an overall measure of sensory processing and reactivity, as well as scores on the following subdomains: Reactivity to Tactile Deep Pressure Visual Tactile Integration Adaptive Motor Function Ocular Motor Control Reactivity to Vestibular Stimulation

Locations

Country	Name	City	State
Turkey	Rabia Eraslan	Yeni?mahalle	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Cacola P, Gabbard C, Santos DC, Batistela AC. Development of the Affordances in the Home Environment for Motor Development-Infant Scale. Pediatr Int. 2011 Dec;53(6):820-5. doi: 10.1111/j.1442-200X.2011.03386.x. — View Citation

Cacola PM, Gabbard C, Montebelo MI, Santos DC. Further Development and Validation of the Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS). Phys Ther. 2015 Jun;95(6):901-23. doi: 10.2522/ptj.20140011. Epub 2014 Dec 18. — View Citation

Kaya-Kara O, Kerem-Gunel M, Yigit S. Correlation of the Bayley scales of infant-toddler development-3rd edition and neuro-sensory motor assessment in preterm infants during the first year of life. Turk J Pediatr. 2019;61(3):399-406. doi: 10.24953/turkjped.2019.03.012. — View Citation

Noble Y, Boyd R. Neonatal assessments for the preterm infant up to 4 months corrected age: a systematic review. Dev Med Child Neurol. 2012 Feb;54(2):129-39. doi: 10.1111/j.1469-8749.2010.03903.x. Epub 2011 Dec 5. — View Citation

Woodward LJ, Anderson PJ, Austin NC, Howard K, Inder TE. Neonatal MRI to predict neurodevelopmental outcomes in preterm infants. N Engl J Med. 2006 Aug 17;355(7):685-94. doi: 10.1056/NEJMoa053792. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Affordances in the Home Environment for Motor Development-Infant Scale	Affordances in the Home Environment for Motor Development-Infant Scale is a parent-filled assessment to determine the nature and amount of factors affecting infant motor skill development in the home environment, including the availability of toys, materials, and the availability of spaces. The scale consists of 41 items in total. For babies aged 3-12 months, questions up to the first 32 items are answered. It is stated that other substances are not suitable for babies under 12 months. All substances are applied to babies between 12-18 months. Questions answered as yes or no are scored as 0.1 (0: no, 1: yes). Other questions are scored as 0, 1, 2, 3. For babies up to 12 months, a total of 66 points is obtained. For babies older than 12 months, a total of 93 points is obtained. A higher score indicates better environmental enrichment.	4-18 months
Primary	Test of Sensory Functions in Infants	This test helps you identify infants with sensory integrative dysfunction-including those at risk for developing learning disabilities as they grow older. All subtests consist of a total of 24 items. In the tactile deep pressure response section, it is scored as 0: reverse response, 1: mild defensive response, and 2: integrated response. In the adaptive motor response section, it is scored as 0: no response, 1: disorganized, 2: partial, 3: organized. In the visual-tactile integration section, it is scored as 0: hyperactive, 1: hyporeactive, and 2: normal. The oculomotor test section is scored as 0: no response or poorly integrated, 1: well integrated. Response to vestibular stimulation is scored as 0: adverse response, 1: mild defensive response, and 2: integrated response. The total score ranges from 0 to 49. In 10-12-month-old babies, 44-49 points indicate good sensory function, 41-43 points indicate risky status, 0-40 points sensory processing problem.	4-18 months
Primary	Peabody Developmental Motor Scales | Second Edition	Peabody Developmental Motor Scales | Second Edition (PDMS-2) combines in-depth assessment with training or remediation of gross and fine motor skills of children from birth through 5 years. It consists of gross motor and fine motor parts. The Gross motor section includes 151 items from 4 subtests: reflexes, stasis, locomotion, and object manipulation. The fine motor section consists of 2 subtests and 98 items: comprehension and visual-motor integration. The total motor part is the sum of the items in the gross and fine 25 motor parts. Items are scored with 0, 1, and 2 points. When the child performs the item according to the specified item criteria, 2 points are given. 1 point is awarded when the behavior occurs but the criteria for successful performance are not fully met. A score of 0 is given when the child is unable to try the item or does not reveal any skills when he tries it. Results are expressed as a raw score, standard score, or total motor score.	4-18 months