PretermNCT06232811
Mother-to-infant Bonding and Prematurity Are Associated With Sensory Processing at 12 Months of Age
An observational study of Preterm and Sensory Disorder, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Preterm, Sensory Disorder, Attachment Disorder
- What is being tested?
- Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2023to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm and term children aged 12 months
Who may be able to join
- preterm children with a gestational age <34 weeks Term children with a gestational age between 37 and 41 weeks
Who cannot join
- infants with chromosomal defects, metabolic or neuromuscular disease,
- hydrocephalus, cerebral palsy, congenital heart disease,
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Preterm, Sensory Disorder, Attachment Disorder
- Being tested
- Assessment
- Medical subject headings
- Premature Birth, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentBehavioural
Sensory processing skills of children in the preterm and term groups will be evaluated. Additionally, the attachment between mother and baby will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Preterm | preterm infants with gestational age <34 weeks Receives: Behavioral: Assessment | |
| Term | term infants with gestational age >37 weeks Receives: Behavioral: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother-to-Infant Bonding Scale
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.
Measured: 15 minutes
Test of Sensory Functions in Infants
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start21 Apr 2023
- Primary completion21 Nov 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Simsek, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232811
- Sponsor's protocol ID
- E-77082166-604.01.02-639350
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mother-to-infant Bonding and Prematurity Are Associated With Sensory Processing at 12 Months of Age
- ClinicalTrials.gov ID
- NCT06232811
- Acronym / sponsor ID
- E-77082166-604.01.02-639350
- Conditions
- Preterm, Sensory Disorder, Attachment Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm | – | Behavioral: Assessmentpreterm infants with gestational age <34 weeks |
| Term | – | Behavioral: Assessmentterm infants with gestational age >37 weeks |
Who may qualify
- Ages
- 12 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm and term children aged 12 months
Key inclusion criteria (1 listed)
- preterm children with a gestational age <34 weeks Term children with a gestational age between 37 and 41 weeks
Key exclusion criteria (2 listed)
- infants with chromosomal defects, metabolic or neuromuscular disease,
- hydrocephalus, cerebral palsy, congenital heart disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentSensory processing skills of children in the preterm and term groups will be evaluated. Additionally, the attachment between mother and baby will be evaluated. | Behavioural | Preterm, Term |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm and Sensory Disorder, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother-to-Infant Bonding Scale (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.