Preterm BirthNCT05210985
Examination of the Relationship Between Home Affordances With Development
An observational study of Preterm Birth, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 4 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Affordances in the Home Environment for Motor Development-Infant Scale, Peabody Developmental Motor Scales-2 and Test Of Sensory Functions In Infants (Tsfı)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: It was planned to include infants who applied to Gazi University Faculty of Health Sciences Physiotherapy and Rehabilitation Department Pediatric Rehabilitation unit in the study. 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. Babies with chromosomal anomalies, serious congenital problems, and whose parents are not willing to work will not be included in the study. In the evaluations, the demographic characteristics of the babies (sex, gestational age, corrected age, birth weight, parental information, mother's pregnancy type, pregnancy history, Apgar score, treatments received, history of staying in the intensive care unit, risk factors) will be recorded in the file and by interviewing the family.
Who may be able to join
None listed.
Who cannot join
- Babies with chromosomal anomaly, serious congenital problems and whose parents are not willing to work will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of the Relationship Between Home Affordances With Motor Development and Sensory Processing in Preterm Infants
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.
Read the detailed 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.
- Conditions
- Preterm Birth
- Being tested
- Affordances in the Home Environment for Motor Development-Infant Scale, Peabody Developmental Motor Scales-2, Test Of Sensory Functions In Infants (Tsfı)
- Keywords
- Preterm, home affordances, Sensory development, motor development
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affordances in the Home Environment for Motor Development-Infant ScaleBehavioural
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-2Behavioural
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 (Tsfı)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| premature babies | 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. Babies with the chromosomal anomalies, serious congenital problems, and whose parents are not willing to work will not be included in the study. Receives: Behavioral: Affordances in the Home Environment for Motor Development-Infant Scale; Behavioral: Peabody Developmental Motor Scales-2; Behavioral: Test Of Sensory Functions In Infants (Tsfı) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-18 months
Test of Sensory Functıons ın 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.
Measured: 4-18 months
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.
Measured: 4-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Eraslan, Gazi University
- Investigators
- Rabia Eraslan, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210985
- Sponsor's protocol ID
- Home affordances
- Status last verified
- Dec 2023
- First submitted
- 14 Jan 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16914704Noble 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.
PubMed 22142216Kaya-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.
PubMed 31916718Cacola 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.
PubMed 25524875Cacola 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.
PubMed 21507146
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Relationship Between Home Affordances With Motor Development and Sensory Processing in Preterm Infants
- ClinicalTrials.gov ID
- NCT05210985
- Acronym / sponsor ID
- Home affordances
- Conditions
- Preterm Birth
- Keywords
- Preterm, home affordances, Sensory development, motor development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premature babies | – | Behavioral: Affordances in the Home Environment for Motor Development-Infant Scale, Behavioral: Peabody Developmental Motor Scales-2, Behavioral: Test Of Sensory Functions In Infants (Tsfı)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. Babies with the chromosomal anomalies, serious congenital problems, and whose parents are not willing to work will not be included in the study. |
Who may qualify
- Ages
- 4 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- It was planned to include infants who applied to Gazi University Faculty of Health Sciences Physiotherapy and Rehabilitation Department Pediatric Rehabilitation unit in the study. 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. Babies with chromosomal anomalies, serious congenital problems, and whose parents are not willing to work will not be included in the study. In the evaluations, the demographic characteristics of the babies (sex, gestational age, corrected age, birth weight, parental information, mother's pregnancy type, pregnancy history, Apgar score, treatments received, history of staying in the intensive care unit, risk factors) will be recorded in the file and by interviewing the family.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Babies with chromosomal anomaly, serious congenital problems and whose parents are not willing to work will not be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affordances in the Home Environment for Motor Development-Infant ScaleAffordances 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. | Behavioural | premature babies |
| Peabody Developmental Motor Scales-2Peabody 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. | Behavioural | premature babies |
| Test Of Sensory Functions In Infants (Tsfı)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 | Behavioural | premature babies |
Primary outcome
Affordances in the Home Environment for Motor Development-Infant Scale
Time frame: 4-18 months
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.
Test of Sensory Functıons ın Infants
Time frame: 4-18 months
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.
Peabody Developmental Motor Scales | Second Edition
Time frame: 4-18 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 16914704Woodward 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.
- Background: PubMed 22142216Noble 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.
- Background: PubMed 31916718Kaya-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.
- Background: PubMed 25524875Cacola 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.
- Background: PubMed 21507146Cacola 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia Eraslan principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affordances in the Home Environment for Motor Development-Infant Scale (time frame: 4-18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05210985, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.