Evaluating the Development of Infants with Colic
Investigation of Motor Development, Sleep Characteristics and Sensory Processing Skills of Infants with a History of Colic
This study looks at how infants who had colic develop in terms of movement, sleep, and sensory skills compared to babies who didn’t have colic.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 44 (estimated) |
| Ages | 10 Months to 15 Months |
| Sex | All |
| Sponsor | Nigde Omer Halisdemir University Academic / other |
| Locations | 2 sites (Ankara and 1 other locations) |
| Trial ID | NCT06866249 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the motor development, sleep characteristics, and sensory processing skills of infants who have a history of colic, comparing them to peers without such a history. Infantile colic is characterized by excessive crying and restlessness in otherwise healthy infants, which can lead to long-term behavioral issues. The study utilizes standardized assessments such as the Peabody Developmental Motor Scales-2 and the Test Of Sensory Functions In Infants to gather data on developmental outcomes. By focusing on infants aged 10-15 months, the research seeks to understand the implications of early colic on later developmental milestones.
Who should consider this trial
Good fit: Ideal candidates include term infants diagnosed with colic who are between 10-15 months old.
Not a fit: Patients who are premature or have congenital malformations or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term developmental impacts of infantile colic, potentially guiding early interventions.
How similar studies have performed: While there is existing literature on the effects of infantile colic, this specific observational approach focusing on developmental outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ankara and 1 other locations
- Gazi University — Ankara, Turkey (Recruiting)
- Nigde Omer Halisdemir University — Nigde, Turkey (Recruiting)
Study contacts
- Principal investigator: Rabia ZORLULAR — Nigde Omer Halisdemir University
- Study coordinator: Rabia ZORLULAR
- Email: rabiaeraslan118@gmail.com
- Phone: +5424362082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.