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Are Developmentally At Risky Babies Environmentally Disadvantaged?

A

Abant Izzet Baysal University

Status

Not yet enrolling

Conditions

Sensory Profiles
Risky Baby
Environmental Conditions
Motor Development

Study type

Observational

Funder types

Other

Identifiers

NCT07063966
BAIBU-FTR-SAT-12

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

7 to 18 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Inclusion Criteria (Developmentally At-Risk Infants):

Infants classified as developmentally at risk

Aged between 7 and 18 months

Parental consent for participation in the study

Inclusion Criteria (Typically Developing Infants):

Aged between 7 and 18 months

Parental consent for participation in the study

Exclusion criteria

  • Infants with unstable vital signs

Infants currently hospitalized

Trial design

52 participants in 2 patient groups

risky babies
Description:
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
Description:
Typically developing children were included as the control group to provide a comparative baseline for assessing developmental differences.

Trial contacts and locations

3

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Central trial contact

Seda AYAZ TAŞ

Data sourced from clinicaltrials.gov

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