Risky BabyNCT07063966
Are Developmentally At Risky Babies Environmentally Disadvantaged?
An observational study of Risky Baby and Motor Development, run by Abant Izzet Baysal University at 3 sites in Turkey (Türkiye).
Trial summary
A study conducted on infants aged between 3 and 11 months revealed a positive relationship between the home environment and developmental outcomes. Similarly, another study found that variability in motor and cognitive development could be better explained by environmental factors and parental knowledge and practices. Read more about this study
- Who is it for?
- Ages 7 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Risky Baby, Motor Development, Sensory Profiles
- How many people
- 52 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 3 Jul 2025to 10 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants who were developmentally at risk, aged between 7 and 18 months, and whose parents consented voluntarily were included in the study. Infants who were hospitalized or had unstable vital signs were excluded. Typically developing infants aged 7 to 18 months with parental consent were included as the control group. Written informed consent was obtained from the parents of all participating infants.
Who may be able to join
- Infants classified as developmentally at risk
- Aged between 7 and 18 months
- Parental consent for participation in the study
- Aged between 7 and 18 months
- Parental consent for participation in the study
Who cannot join
- Infants with unstable vital signs
- Infants currently hospitalized
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites
Bolu Abant İzzet Baysal University
Bolu
Seda AYAZ TAŞ, 05495458040, seda.ayaztas@ibu.edu.tr
Düzce Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi
Düzce
Seda AYAZ TAŞ, 05495458040
Kdz. Ereğli Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi
Zonguldak, Ereğli
Seda AYAZ TAŞ, 05495458040, seda.ayaztas@ibu.edu.tr
About this study
A study conducted on infants aged between 3 and 11 months revealed a positive relationship between the home environment and developmental outcomes. Similarly, another study found that variability in motor and cognitive development could be better explained by environmental factors and parental knowledge and practices. It has also been shown that the opportunities provided in the home environment of preterm infants may be associated with motor development and sensory processing skills. In the literature, it is generally observed that studies evaluate either term infants or both preterm and term infants together. In the present study, however, infants at developmental risk and typically developing infants will be evaluated separately.
The aim of this study is to assess whether infants at developmental risk are disadvantaged in terms of their home environment.
Read more
The hypotheses of this study are as follows:
H1-1: There is a difference in environmental arrangements between typically developing infants and those at developmental risk.
H1-2: There is a relationship between home environmental arrangements and motor development.
H1-3: There is a relationship between home environmental arrangements and sensory profile.
Read the detailed description
A "high-risk infant" is defined as a baby who has experienced any adverse environmental or biological factors in their medical history and is therefore at increased risk for neurodevelopmental problems. Exposure to various factors during the prenatal, natal, and postnatal periods may negatively affect the development of these infants.
In the prenatal period, maternal use of medications, alcohol, or tobacco; chronic maternal illnesses (such as diabetes, hypertension, congenital heart disease, or renal failure); infections during pregnancy; congenital anomalies; intrauterine growth restriction; multiple pregnancies; preeclampsia; eclampsia; and placenta previa are considered risk factors for the baby. During the natal period, complications such as preterm or postterm birth, premature rupture of membranes, birth trauma, perinatal asphyxia, intrauterine hemorrhage, and meconium aspiration may threaten infant health. In the postnatal period, birth weight below 2500 grams or above 4000 grams, neonatal sepsis and meningitis, intraventricular hemorrhage, feeding difficulties, hypoglycemia, respiratory distress syndrome, respiratory failure, a history of ventilator support, and hyperbilirubinemia are considered developmental risk factors.
Infants diagnosed with Down syndrome, rare genetic disorders, epilepsy/seizure disorders, or neuromuscular diseases are also classified as developmentally at-risk. Due to these diverse factors, infants at risk may not develop typically. These infants are vulnerable to developmental delays and neurodevelopmental disorders that may affect motor skills, cognitive abilities, and sensory processing. High-risk infants, such as those born prematurely, often demonstrate impairments in both gross and fine motor skills. It has been reported that individuals born very preterm and with very low birth weight, but without cerebral palsy, still exhibit significant motor impairments compared to their term-born peers.
Preterm infants are also at increased risk for difficulties in social-emotional, cognitive, language, and sensory processing domains. It has been shown that infants born before 32 weeks of gestation often experience challenges in sensory processing. In one study, preterm infants demonstrated altered sensory processing patterns, with reduced responses to deep tactile pressure and vestibular input. A positive association has been observed between motor development and sensory processing, and delayed gross motor development is more likely in preterm infants who display abnormal sensory processing and poor postural control. These developmental limitations can worsen as the child grows, especially in environments lacking sufficient developmental stimulation.
Environmental factors encompass the physical, social, and behavioral settings in which an individual lives. A rich and stimulating environment during early life has been shown to support stronger neural connections in the brain and contribute positively to a child's overall development-including motor, language, cognitive, and literacy skills. During the first years of life, children spend most of their time in the home environment. Therefore, the home plays a critical role in early childhood development, and the presence of various stimulating materials during this period is of great importance. A supportive home environment includes educational materials such as toys and books, adequate physical space, and stimuli provided by family members. Research has shown that family support, environmental conditions, and interactions with toys positively influence children's motor, social, and cognitive development. During infancy and early childhood, sensory processing enables learning by integrating experiences and forms the foundation for more advanced perceptual and cognitive abilities. In this context, motor development and sensory processing are complementary and mutually supportive developmental processes.
- Keywords
- risky baby, motor development, sensory profiles, environmental conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| risky babies | High-risk infants are defined as those exposed to adverse biological or environmental factors that increase the risk of neurodevelopmental issues. Prenatal risk factors include maternal substance use, chronic illnesses, infections, and complications such as intrauterine growth restriction or multiple pregnancies. Natal risks involve preterm or postterm birth, birth trauma, and perinatal asphyxia. Postnatal risks include low or high birth weight, neonatal infections, respiratory problems, and feeding difficulties. Additionally, infants with genetic conditions like Down syndrome, epilepsy, or neuromuscular diseases are considered developmentally at risk. | |
| control group | Typically developing children were included as the control group to provide a comparative baseline for assessing developmental differences. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Home Environment Supporting Motor Development - Infant Scale (AHEMD-IS):
The AHEMD-SR, developed in 2005, evaluates the home environment of children aged 18-42 months. Recently, the 3-18 month version (AHEMD-IS) was validated to assess the quality and quantity of motor development opportunities at home. The scale has 41 items across four domains: Physical Space (indoor/outdoor), Variety of Stimulation, Gross Motor Toys, and Fine Motor Toys. Home environments are rated as excellent, adequate, moderate, or inadequate. For infants 3-11 months, 32 items are applicable; 12-18 months respond to all items. Responses include yes/no (0/1) and frequency scales from never (0) to always (3). Maximum scores are 66 for under 12 months and 93 for older infants; higher scores indicate better environmental enrichment. Turkish validity and reliability were confirmed with Cronbach's alpha of 0.846 and ICC of 0.830. Author permission was obtained.
Measured: 2 year
Secondary outcomes (3)
Alberta Infant Motor Scale (AIMS):
AIMS is a standardized tool assessing gross motor development from birth to independent walking (up to 18 months). It identifies motor delays, monitors progress pre- and post-intervention, and evaluates rehabilitation effectiveness. Infants are observed in four positions: prone, supine, sitting, and standing. Movements related to weight-bearing, posture, and antigravity are scored. Each observed movement scores 1, unobserved 0, focusing on the "developmental window" of the two most mature movements. Scores per position are summed for a raw score, converted to age-based percentiles to assess motor level. Assessment takes 20-30 minutes, ideally with caregiver present for infant comfort. AIMS is widely used to profile infant motor development.
Measured: 2 year
Sensory Profile Assessment:
The Toddler Sensory Profile-2 (7-35 months) is a parent-report questionnaire designed to evaluate sensory processing in infants. It consists of 54 items and takes approximately 15 minutes to complete. In this study, it will be applied to infants aged 7-18 months. Parents rate the frequency of their child's responses to various sensory experiences on a 5-point scale: Almost Always (5), Often (4), Sometimes (3), Rarely (2), Almost Never (1), with an additional "Not Applicable" option. Total raw scores are classified using normative curves and sensory classification as follows: (i) Much less than others (<2%), (ii) Less than others (1-2 SD below mean), (iii) Similar to most (±1 SD), (iv) More than others (1-2 SD above mean), (v) Much more than others (>98%).
Measured: 2 year
Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III):
Bayley-III is a reliable and valid tool for assessing cognitive, language, and motor development in children aged 0-42 months. It identifies developmental delays and aids intervention planning. The scale provides raw scores, standard scores, percentile ranks, and growth scores, detailing performance in subscales: Cognitive, Receptive and Expressive Communication, Fine Motor, and Gross Motor. Scoring awards 1 point for correct and 0 for incorrect responses. Developmental scores range from 200 to 800 (mean=500, SD=100). The test follows basal and ceiling rules for item administration. Assessment requires a quiet, well-lit environment, fostering a warm, trusting interaction. Materials are engaging and hygienically maintained. Bayley-III is widely used by multidisciplinary teams for diagnosis and research, especially in early intervention. The research team's certified examiner will conduct the assessment.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start3 Jul 2025 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risky BabyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda AYAZ TAŞ, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063966
- Sponsor's protocol ID
- BAIBU-FTR-SAT-12
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Developmentally At Risky Babies Environmentally Disadvantaged?
- ClinicalTrials.gov ID
- NCT07063966
- Acronym / sponsor ID
- BAIBU-FTR-SAT-12
- Keywords
- risky baby, motor development, sensory profiles, environmental conditions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 3 Jul 2025 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Nov 2025 (estimated)
- First posted
- 14 Jul 2025 (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.
A study conducted on infants aged between 3 and 11 months revealed a positive relationship between the home environment and developmental outcomes. Similarly, another study found that variability in motor and cognitive development could be better explained by environmental factors and parental knowledge and practices. It has also been shown that the opportunities provided in the home environment of preterm infants may be associated with motor development and sensory processing skills. In the literature, it is generally observed that studies evaluate either term infants or both preterm and term infants together. In the present study, however, infants at developmental risk and typically developing infants will be evaluated separately.
The aim of this study is to assess whether infants at developmental risk are disadvantaged in terms of their home environment.
The hypotheses of this study are as follows:
H1-1: There is a difference in environmental arrangements between typically developing infants and those at developmental risk.
H1-2: There is a relationship between home environmental arrangements and motor development.
H1-3: There is a relationship between home environmental arrangements and sensory profile.
Detailed description
A "high-risk infant" is defined as a baby who has experienced any adverse environmental or biological factors in their medical history and is therefore at increased risk for neurodevelopmental problems. Exposure to various factors during the prenatal, natal, and postnatal periods may negatively affect the development of these infants.
In the prenatal period, maternal use of medications, alcohol, or tobacco; chronic maternal illnesses (such as diabetes, hypertension, congenital heart disease, or renal failure); infections during pregnancy; congenital anomalies; intrauterine growth restriction; multiple pregnancies; preeclampsia; eclampsia; and placenta previa are considered risk factors for the baby. During the natal period, complications such as preterm or postterm birth, premature rupture of membranes, birth trauma, perinatal asphyxia, intrauterine hemorrhage, and meconium aspiration may threaten infant health. In the postnatal period, birth weight below 2500 grams or above 4000 grams, neonatal sepsis and meningitis, intraventricular hemorrhage, feeding difficulties, hypoglycemia, respiratory distress syndrome, respiratory failure, a history of ventilator support, and hyperbilirubinemia are considered developmental risk factors.
Infants diagnosed with Down syndrome, rare genetic disorders, epilepsy/seizure disorders, or neuromuscular diseases are also classified as developmentally at-risk. Due to these diverse factors, infants at risk may not develop typically. These infants are vulnerable to developmental delays and neurodevelopmental disorders that may affect motor skills, cognitive abilities, and sensory processing. High-risk infants, such as those born prematurely, often demonstrate impairments in both gross and fine motor skills. It has been reported that individuals born very preterm and with very low birth weight, but without cerebral palsy, still exhibit significant motor impairments compared to their term-born peers.
Preterm infants are also at increased risk for difficulties in social-emotional, cognitive, language, and sensory processing domains. It has been shown that infants born before 32 weeks of gestation often experience challenges in sensory processing. In one study, preterm infants demonstrated altered sensory processing patterns, with reduced responses to deep tactile pressure and vestibular input. A positive association has been observed between motor development and sensory processing, and delayed gross motor development is more likely in preterm infants who display abnormal sensory processing and poor postural control. These developmental limitations can worsen as the child grows, especially in environments lacking sufficient developmental stimulation.
Environmental factors encompass the physical, social, and behavioral settings in which an individual lives. A rich and stimulating environment during early life has been shown to support stronger neural connections in the brain and contribute positively to a child's overall development-including motor, language, cognitive, and literacy skills. During the first years of life, children spend most of their time in the home environment. Therefore, the home plays a critical role in early childhood development, and the presence of various stimulating materials during this period is of great importance. A supportive home environment includes educational materials such as toys and books, adequate physical space, and stimuli provided by family members. Research has shown that family support, environmental conditions, and interactions with toys positively influence children's motor, social, and cognitive development. During infancy and early childhood, sensory processing enables learning by integrating experiences and forms the foundation for more advanced perceptual and cognitive abilities. In this context, motor development and sensory processing are complementary and mutually supportive developmental processes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| risky babies | – | –High-risk infants are defined as those exposed to adverse biological or environmental factors that increase the risk of neurodevelopmental issues. Prenatal risk factors include maternal substance use, chronic illnesses, infections, and complications such as intrauterine growth restriction or multiple pregnancies. Natal risks involve preterm or postterm birth, birth trauma, and perinatal asphyxia. Postnatal risks include low or high birth weight, neonatal infections, respiratory problems, and feeding difficulties. Additionally, infants with genetic conditions like Down syndrome, epilepsy, or neuromuscular diseases are considered developmentally at risk. |
| control group | – | –Typically developing children were included as the control group to provide a comparative baseline for assessing developmental differences. |
Who may qualify
- Ages
- 7 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants who were developmentally at risk, aged between 7 and 18 months, and whose parents consented voluntarily were included in the study. Infants who were hospitalized or had unstable vital signs were excluded. Typically developing infants aged 7 to 18 months with parental consent were included as the control group. Written informed consent was obtained from the parents of all participating infants.
Key inclusion criteria (5 listed)
- Infants classified as developmentally at risk
- Aged between 7 and 18 months
- Parental consent for participation in the study
- Aged between 7 and 18 months
- Parental consent for participation in the study
Key exclusion criteria (2 listed)
- Infants with unstable vital signs
- Infants currently hospitalized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Home Environment Supporting Motor Development - Infant Scale (AHEMD-IS):
Time frame: 2 year
The AHEMD-SR, developed in 2005, evaluates the home environment of children aged 18-42 months. Recently, the 3-18 month version (AHEMD-IS) was validated to assess the quality and quantity of motor development opportunities at home. The scale has 41 items across four domains: Physical Space (indoor/outdoor), Variety of Stimulation, Gross Motor Toys, and Fine Motor Toys. Home environments are rated as excellent, adequate, moderate, or inadequate. For infants 3-11 months, 32 items are applicable; 12-18 months respond to all items. Responses include yes/no (0/1) and frequency scales from never (0) to always (3). Maximum scores are 66 for under 12 months and 93 for older infants; higher scores indicate better environmental enrichment. Turkish validity and reliability were confirmed with Cronbach's alpha of 0.846 and ICC of 0.830. Author permission was obtained.
3 secondary outcomes
Alberta Infant Motor Scale (AIMS):
Time frame: 2 year
Sensory Profile Assessment:
Time frame: 2 year
Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III):
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Risky Baby
Not yet recruiting
Synchronous vs. Asynchronous Telerehabilitation for High-Risk Infants
Risky Baby, Premature Birth of Newborn
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risky Baby and Motor Development, run by Abant Izzet Baysal University at 3 sites 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seda AYAZ TAŞ (05495458040, seda.ayaztas@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Home Environment Supporting Motor Development - Infant Scale (AHEMD-IS): (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2025.