Clinical trial NCT06866249: Investigation of the Development of Infants with a History of Colic
Official title: Investigation of Motor Development, Sleep Characteristics and Sensory Processing Skills of Infants with a History of Colic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colic, Infantile
Motor Development
Sleep
Sensory Integration Dysfunction
Keywords: Infantile colic
developmental outcomes
motor development
sensory processing
sleep
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 44
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Peabody Developmental Motor Scales | Second Edition (PDMS-2)
timeFrame: 10-15 months
measure: Test of Sensory Functıons ın Infants
timeFrame: 10-15 months
measure: Brief Infant Sleep Questionnaire
timeFrame: 10-15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
city: Nigde
country: Turkey
facility: Nigde Omer Halisdemir University
Study officials:
affiliation: Nigde Omer Halisdemir University
name: Rabia ZORLULAR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: Folio, M.R., Peabody developmental motor scales. DLM Teaching Resources, 1983.
citation: 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.