Investigation of the Development of Infants With a History of Colic

NCT06866249 | Completed

• 1 other identifier: colic infant and development
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study was to evaluate the motor development, sleep characteristics and sensory processing skills of infants with a history of colic and to compare them with their peers without a history of colic.

Conditions

Colic, Infantile; Motor Development; Sleep; Sensory Integration Dysfunction

Keywords

Infantile colic; developmental outcomes; motor development; sensory processing; sleep

Outcome Measures

Primary Outcomes (3)

• Peabody Developmental Motor Scales | Second Edition (PDMS-2)

  Peabody Developmental Motor Scales \| Second Edition (PDMS-2) in-depth assessment with training or remediation of gross and fine motor skills of children from birth through 5 years. It consists of gross motor and fine motor parts. The Gross motor section includes 151 items from 4 subtests: reflexes, stasis, locomotion, and object manipulation. The fine motor section consists of 2 subtests and 98 items: comprehension and visual-motor integration. The total motor part is the sum of the items in the gross and fine 25 motor parts. Items are scored with 0, 1, and 2 points. When the child performs the item according to the specified item criteria, 2 points are given. One point is awarded when the behavior occurs, but the criteria for successful performance are not fully met. A score of 0 is given when the child is unable to try the item or does not reveal any skills when he tries it. Results are expressed as raw, standard, or total motor scores.

  10-15 months

• Test of Sensory Functıons ın Infants

  This test helps you identify infants with sensory integrative dysfunction-including those at risk for developing learning disabilities as they grow older. All subtests consist of a total of 24 items. In the tactile deep pressure response section, it is scored as 0: reverse response, 1: mild defensive response, and 2: integrated response. In the adaptive motor response section, it is scored as 0: no response, 1: disorganized, 2: partial, 3: organized. In the visual-tactile integration section, it is scored as 0: hyperactive, 1: hyporeactive, and 2: normal. The oculomotor test section is scored as 0: no response or poorly integrated, 1: well integrated. Response to vestibular stimulation is scored as 0: adverse response, 1: mild defensive response, and 2: integrated response. The total score ranges from 0 to 49. In 10-12-month-old babies, 44-49 points indicate good sensory function, 41-43 points indicate risky status, 0-40 points sensory processing problem.

  10-15 months

• Brief Infant Sleep Questionnaire

  The Brief Infant Sleep Questionnaire will be used to assess sleep. Infant sleep problems are among the most common problems presented to pediatricians. The extended version of the "Brief Infant Sleep Questionnaire" is a questionnaire developed by Sadeh to assess sleep problems and their causes in early childhood. This questionnaire has been translated into Turkish and assessed sleep environment and sleep problems in infants. It consists of 33 items, is based on parental reports of infant or toddler sleep patterns and is used to validate the data. It is associated with daily records and parental sleep reports. Its sensitivity in documenting developmental sleep trends is well established

  10-15 months

Study Arms (2)

Infantile colic

The study planned to include infants with a history of colic and their families. Evaluations will cover the demographic characteristics of the infants, sensory processing skills, motor development, and sleep patterns.

Behavioral: Peabody Developmental Motor Scales-2; Behavioral: Test Of Sensory Functions In Infants (Tsfı); Behavioral: Brief Infant Sleep Questionnaire

Healthy infants

A control group consisting of healthy infants born at term with no history of colic will be established. Evaluations will include the demographic characteristics of the infants, sensory processing skills, motor development, and sleep patterns.

Behavioral: Peabody Developmental Motor Scales-2; Behavioral: Test Of Sensory Functions In Infants (Tsfı); Behavioral: Brief Infant Sleep Questionnaire

Interventions

Peabody Developmental Motor Scales-2 BEHAVIORAL

Peabody Developmental Motor Scales \| Second Edition (PDMS-2) combines in-depth assessment with training or remediation of gross and fine motor skills of children. The test is designed to identify de

Healthy infants; Infantile colic

Test Of Sensory Functions In Infants (Tsfı) BEHAVIORAL

Test Of Sensory Functions In Infants (TSFI) provides objective criteria that allow you to determine whether, and to what extent, an infant has deficits in sensory functioning. Designed for use with children from 4 months to 18 months old.

Healthy infants; Infantile colic

Brief Infant Sleep Questionnaire BEHAVIORAL

Infant sleep problems are among the most common problems presented to pediatricians. The extended version of the "Brief Infant Sleep Questionnaire" is a questionnaire developed by Sadeh to assess sleep problems and their causes in early childhood.

Healthy infants; Infantile colic

Eligibility Criteria

• Age: 10 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

It was planned to include infants and families with a history of colic in the study. Children between 10-15 months of age and whose parents' consent was obtained will be included in the study.Additionally, infants and their families between 10 and 15 months of age with no history of colic will be included to compare their development.

You may qualify if:

• Term infatns born at term
• Infants diagnosed with colic
• Post-term infants between 10-15 months

You may not qualify if:

• Premature infants
• Infants with congenital malformations
• Infants diagnosed with metabolic, neurological and genetic diseases
• Children whose parents do not volunteer for the study

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (2)

Gazi University

Ankara, Turkey (Türkiye)

Location

Nigde Omer Halisdemir University

Niğde, Turkey (Türkiye)

Location

Related Publications (4)

• DeGangi, G.A. and S.I. Greenspan, The development of sensory functions in infants. Physical & Occupational Therapy in Pediatrics, 1989. 8(4): p. 21-33

  BACKGROUND

• Boran, P., et al., Translation into Turkish of the expanded version of the "Brief Infant Sleep Questionnaire" and its application to infants. Marmara Medical Journal, 2014. 27(3): p. 178-183.

  BACKGROUND

• Folio, M.R., Peabody developmental motor scales. DLM Teaching Resources, 1983.

  BACKGROUND

• Canivet C, Jakobsson I, Hagander B. Infantile colic. Follow-up at four years of age: still more "emotional". Acta Paediatr. 2000 Jan;89(1):13-7. doi: 10.1080/080352500750028988.

  PMID: 10677050 BACKGROUND

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rabia ZORLULAR

  Nigde Omer Halisdemir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: March 12, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)