Investigation of the Development of Infants with a History of Colic

Last updated: March 19, 2025
Sponsor: Nigde Omer Halisdemir University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Treatment

Peabody Developmental Motor Scales-2

Brief Infant Sleep Questionnaire

Test Of Sensory Functions In Infants (Tsfı)

Clinical Study ID

NCT06866249
colic infant and development
  • Ages 10-15
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Term infatns born at term

  • Infants diagnosed with colic

  • Post-term infants between 10-15 months

Exclusion

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

Study Design

Total Participants: 44
Treatment Group(s): 3
Primary Treatment: Peabody Developmental Motor Scales-2
Phase:
Study Start date:
March 12, 2025
Estimated Completion Date:
May 15, 2025

Study 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.

Connect with a study center

  • Gazi University

    Ankara,
    Turkey

    Active - Recruiting

  • Nigde Omer Halisdemir University

    Nigde,
    Turkey

    Active - Recruiting

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