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Investigation of the Development of Infants with a History of Colic

N

Nigde Omer Halisdemir University

Status

Enrolling

Conditions

Colic, Infantile
Sensory Integration Dysfunction
Motor Development
Sleep

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06866249
colic infant and development

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 estimated patients

Sex

All

Ages

10 to 15 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

44 participants in 2 patient groups

Infantile colic
Description:
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.
Treatment:
Behavioral: Test Of Sensory Functions In Infants (Tsfı)
Behavioral: Brief Infant Sleep Questionnaire
Behavioral: Peabody Developmental Motor Scales-2
Healthy infants
Description:
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.
Treatment:
Behavioral: Test Of Sensory Functions In Infants (Tsfı)
Behavioral: Brief Infant Sleep Questionnaire
Behavioral: Peabody Developmental Motor Scales-2

Trial contacts and locations

2

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Central trial contact

Rabia ZORLULAR

Data sourced from clinicaltrials.gov

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