Clinical Trials Logo
  1. Home
  2. Infant Development
  3. NCT05749796
  4. Details
NCT05749796 Clinical Trial

Investigation of the Relationship Between Development, Neurological Assessment and Object Permanence in High Risk Infants.

Infant Development Clinical Trial

Official title:
Investigation of the Relationship Between Development, Neurological Assessment and Object Permanence in High Risk Infants.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05749796
Other study ID # GaziosmanpasaU_Erol_04
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date May 31, 2024

Study information
Verified date September 2023
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to examine the relationship between development, neurological assessment and object permanence in risky infants aged 7-16 months. The sample of the study will consist of babies between 7-16 months at risk (preterm, low birth weight, asphyxia, hyperbillirubinemia, etc.). Inclusion criteria for the study: Between 7-16 months, having at least one risk factor. Exclusion criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder. Parents who agreed to participate in the study will be asked to fill out the demographic information questionnaire. Object permanence scale, Bayley III infant and toddler development scale and Hammersmith infant neurologic assessment will be applied to infants.

Recruitment information / eligibility
Status Recruiting
Enrollment 32
Est. completion date May 31, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers
Gender All
Age group 7 Months to 16 Months
Eligibility Inclusion Criteria: - Between 7-16 months, having at least one risk factor Exclusion Criteria: - Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Faculty of Health Sciences, Tokat Gaziosmanpasa University Tokat

Sponsors (1)
Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Object Permanence Scale The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome. Baseline
Primary The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales Cognitive subscale consists of 91 items and Motor subscale consists of 138 items. Items are scored as 1 (done) and 0 not able to). Higher scores indicate better outcome. Baseline
Primary Hammersmith infant neurological assessment Each item is individually scored from zero to three, and individual scores are summed to obtain a global optimality score. The overall score can range from a minimum of 0 to a maximum of 78 points. Baseline
See also
  Status Clinical Trial Phase
Recruiting NCT05793112 - INF108F in Infants With Food Protein Induced Proctocolitis Phase 4
Recruiting NCT03828708 - Early Iron Exposure on the Gut Microbiota in Young Infants N/A
Recruiting NCT06018064 - Investigating Fit and Satisfaction of the Prone Positioner N/A
Not yet recruiting NCT06335524 - Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants N/A
Not yet recruiting NCT05039918 - Neonatal Experience of Social Touch N/A
Completed NCT01166867 - A Pilot Study Using Photo-plethysmographic (PPG) Camera
Completed NCT00791466 - Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development N/A
Completed NCT03331276 - Growth and Safety Study of an Infant Formula for Healthy Term Infants N/A
Completed NCT05157633 - Oral Exploration of Objects and Food Diversification
Completed NCT05217186 - Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
Recruiting NCT05006989 - Blueberry Intake and Infant Gut Health N/A
Completed NCT04901611 - Parental Touch Trial (Petal) N/A
Completed NCT03082313 - Movement-based Infant Intervention N/A
Recruiting NCT06053515 - Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication N/A
Completed NCT05394883 - The SPROUT (Pilot) Project N/A
Completed NCT03991949 - Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula N/A
Active, not recruiting NCT03851120 - Brain Probiotic and LC-PUFA Intervention for Optimum Early Life Phase 2
Completed NCT03662048 - Improving Infant Sleep Safety With the Electronic Health Record N/A
Active, not recruiting NCT04749888 - Impact of the Korea Early Childhood Home-visiting Intervention N/A
Recruiting NCT06230848 - Multisensory Early Oral Administration of Human Milk in Preterm Infants N/A