NCT06232811

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

January 22, 2024

Last Update Submit

January 22, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    30 minutes

Study Arms (2)

Preterm

preterm infants with gestational age \<34 weeks

Behavioral: Assessment

Term

term infants with gestational age \>37 weeks

Behavioral: Assessment

Interventions

AssessmentBEHAVIORAL

Sensory processing skills of children in the preterm and term groups will be evaluated. Additionally, the attachment between mother and baby will be evaluated.

PretermTerm

Eligibility Criteria

Age12 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preterm and term children aged 12 months

You may qualify if:

  • preterm children with a gestational age \<34 weeks Term children with a gestational age between 37 and 41 weeks

You may not qualify if:

  • infants with chromosomal defects, metabolic or neuromuscular disease,
  • hydrocephalus, cerebral palsy, congenital heart disease,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum Technical University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature BirthSensation Disorders

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gazi University

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 31, 2024

Study Start

April 21, 2023

Primary Completion

November 21, 2023

Study Completion

January 15, 2024

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations