Are Developmentally At Risky Babies Environmentally Disadvantaged?

NCT07063966 | Not Yet Recruiting

• 1 other identifier: BAIBU-FTR-SAT-12
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 3

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.

Conditions

Risky Baby; Motor Development; Sensory Profiles; Environmental Conditions

Keywords

risky baby; motor development; sensory profiles; environmental conditions

Outcome Measures

Primary Outcomes (1)

• 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.

  2 year

Secondary Outcomes (3)

• Alberta Infant Motor Scale (AIMS):

  2 year

• Sensory Profile Assessment:

  2 year

• Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III):

  2 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 7 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Infants with unstable vital signs
• Infants currently hospitalized

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (3)

Kdz. Ereğli Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi

Zonguldak, Ereğli, Turkey (Türkiye)

Location

Bolu Abant İzzet Baysal University

Bolu, Turkey (Türkiye)

Location

Düzce Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi

Düzce, Turkey (Türkiye)

Location

Central Study Contacts

Seda AYAZ TAŞ

CONTACT

05495458040; seda.ayaztas@ibu.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: July 3, 2025
• Primary Completion: September 10, 2025
• Study Completion: November 10, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)