Are Developmentally At Risky Babies Environmentally Disadvantaged?

NCT ID: NCT07063966

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-03
• Study Completion Date: 2025-11-10

Brief 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. 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.

Conditions

Risky Baby; Motor Development; Sensory Profiles; Environmental Conditions

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

control group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Infants with unstable vital signs

Infants currently hospitalized

• Minimum Eligible Age: 7 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Seda AYAZ TAŞ

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kdz. Ereğli Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi

Zonguldak, Ereğli, Turkey (Türkiye)

Bolu Abant İzzet Baysal University

Bolu, , Turkey (Türkiye)

Düzce Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi

Düzce, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Seda AYAZ TAŞ

Role: CONTACT

seda.ayaztas@ibu.edu.tr

05495458040

Facility Contacts

Seda AYAZ TAŞ

Role: primary

seda.ayaztas@ibu.edu.tr

05495458040

Seda AYAZ TAŞ

Role: primary

seda.ayaztas@ibu.edu.tr

05495458040

Seda AYAZ TAŞ

Role: primary

05495458040

Other Identifiers

BAIBU-FTR-SAT-12

Identifier Type: -

Identifier Source: org_study_id