Investigation of the Development of Infants With a History of Colic

NCT ID: NCT06866249

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-12
• Study Completion Date: 2025-05-01

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.

Detailed Description

Infantile colic (IC) is a condition characterized by incessant crying and restlessness in healthy, normally growing infants. Prolonged and intense crying in an otherwise healthy infant is a significant challenge for families. Infantile colic was first described by Wessel nearly 50 years ago. According to Wessel, episodes of crying and restlessness that last three hours a day, at least three days a week, for a minimum of three weeks are classified as infantile colic.

The long-term effects of IC include an increased risk of behavioral problems in children. A meta-analysis found that children with a history of excessive crying are more likely to develop general behavioral problems, internalizing problems (such as anxiety, depression, or withdrawal), and externalizing problems (such as aggression or disruptive behavior). Additionally, these difficulties are exacerbated by adverse family environments, including parental stress or poor maternal mental health. As these infants approach preschool age, they may struggle with sustaining attention, engaging in reciprocal play interactions, and tolerating change and separation.

The first two years of life are a critical period for supporting infant development, as brain growth and neural plasticity progress rapidly. When children reach 10-15 months of age and begin exploring their environment through walking and trial-and-error experiences, assessing sensory processing skills becomes particularly important. At this stage, children actively expand their motor repertoire, especially while developing skills such as crawling and walking. However, a review of existing studies reveals a lack of evaluations conducted during the toddler, preschool, and school-age periods. Furthermore, most studies focus primarily on behavioral problems and attention deficit hyperactivity disorder (ADHD). For this reason, 10-15-month-old infants were included in this study to assess early-stage development.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Peabody Developmental Motor Scales-2

Intervention Type: 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

Test Of Sensory Functions In Infants (Tsfı)

Intervention Type: 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.

Brief Infant Sleep Questionnaire

Intervention Type: 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

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.

Peabody Developmental Motor Scales-2

Intervention Type: 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

Test Of Sensory Functions In Infants (Tsfı)

Intervention Type: 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.

Brief Infant Sleep Questionnaire

Intervention Type: 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.

Interventions

Peabody Developmental Motor Scales-2

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

Intervention Type: BEHAVIORAL

Test Of Sensory Functions In Infants (Tsfı)

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.

Intervention Type: BEHAVIORAL

Brief Infant Sleep Questionnaire

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 10 Months
• Maximum Eligible Age: 15 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nigde Omer Halisdemir University

OTHER

Sponsor Role: lead

Responsible Party

Rabia ZORLULAR

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rabia ZORLULAR

Role: PRINCIPAL_INVESTIGATOR

Nigde Omer Halisdemir University

Locations

Gazi University

Ankara, , Turkey (Türkiye)

Nigde Omer Halisdemir University

Niğde, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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

Reference Type: 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.

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 10677050 (View on PubMed)

Other Identifiers

colic infant and development

Identifier Type: -

Identifier Source: org_study_id