- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06232811
Mother-to-infant Bonding and Prematurity Are Associated With Sensory Processing at 12 Months of Age
January 22, 2024 updated by: Ayse Simsek, Gazi University
Establishing a strong bond between mother and infant is crucial for fostering healthy relationships in the future.
This research sought to investigate the correlation between mother-to-infant bonding and sensory processing, as well as the connection between prematurity and sensory processing in 12-month-old infants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
At the age of four months, mothers will utilize the Mother-Infant Attachment Scale (MIBS) to evaluate the bonding between themselves and their infants.
Subsequently, at 12 months old, the sensory processing abilities of the infants will be assessed using the Test of Sensory Functions in Infants (TSFI).
The study will encompass both preterm and term-born children.
Study Type
Observational
Enrollment (Actual)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Erzurum, Turkey
- Erzurum Technical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Preterm and term children aged 12 months
Description
Inclusion Criteria:
preterm children with a gestational age <34 weeks Term children with a gestational age between 37 and 41 weeks
Exclusion Criteria:
- infants with chromosomal defects, metabolic or neuromuscular disease,
- hydrocephalus, cerebral palsy, congenital heart disease,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Preterm
preterm infants with gestational age <34 weeks
|
Sensory processing skills of children in the preterm and term groups will be evaluated.
Additionally, the attachment between mother and baby will be evaluated.
|
|
Term
term infants with gestational age >37 weeks
|
Sensory processing skills of children in the preterm and term groups will be evaluated.
Additionally, the attachment between mother and baby will be evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mother-to-Infant Bonding Scale
Time Frame: 15 minutes
|
The Mother-to-Infant Bonding Scale is a tool designed for evaluating mother-infant bonding.
Comprising 10 items on a 4-point scale, this scale yields a total score ranging from 0 to 30.
Higher scores on the scale are indicative of poorer mother-to-infant bonding.
|
15 minutes
|
|
Test of Sensory Functions in Infants
Time Frame: 30 minutes
|
The test consists of 24 items divided into five subtests: sensory processing and reactivity.
subtests include: deep pressure, adaptive motor functions, visual-tactile integration, ocular-motor control, and vestibular stimulation.
By observing the baby's response, items are scored from negative to normal according to the criteria provided; Items are given 0, 1 or 2 points depending on the baby's reaction.
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 21, 2023
Primary Completion (Actual)
November 21, 2023
Study Completion (Actual)
January 15, 2024
Study Registration Dates
First Submitted
January 22, 2024
First Submitted That Met QC Criteria
January 22, 2024
First Posted (Actual)
January 31, 2024
Study Record Updates
Last Update Posted (Actual)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 22, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-77082166-604.01.02-639350
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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