NCT06866249

Investigation of the Development of Infants With a History of Colic

Investigation of Motor Development, Sleep Characteristics and Sensory Processing Skills of Infants With a History of Colic

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Nigde Omer Halisdemir University · Academic / Other
• Sex: All
• Age: 10 Months – 15 Months
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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
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.
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.

Timeline

• Start date: 2025-03-12
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2025-03-10
• Last updated: 2025-06-26

Locations

2 sites across 1 country: Turkey (Türkiye)