Infants Colics : Towards a Migrainous Origin ?

Migraine Clinical Trial

— COLIGRAINE  

Official title:

Association Between Infant Colics and Parental Migraine ? Non Interventional Study in the Pediatric Emergency Unit of Nancy (France) University Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03155360
• Other study ID #: 2017-A00185-48
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2017
• Last updated: August 8, 2017
• Start date: May 18, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: August 2017
• Source: Central Hospital, Nancy, France
• Contact: François BREZIN
• Phone: 00 33 6 63 78 08 87
• Email: francois.brezin[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

According to recent studies, we want to find evidences that infant colics could be a episodic symptom associated to migraine as cyclic vomiting syndrome or abdominal migraine are. The main purpose is to compare the presence of colics in infants between 60 days and 180 days of life and the presence of migraine in their parents to determine if colicky children's parents are more migrainous than other parents.

Description:

Recent studies shows that :

• Infants with colics have more probability to become migrainous when they will grow up

• Migrainous children have more colic history in their past

• Migrainous parents have more babies with colics than non-migrainous parents

According to these studies, we want to find othen evidences that infant colics could be a migraine equivalent as cyclic vomiting syndrome or abdominal migraine are. Recently, the international classification of headache disease IIIbeta added in its appendix colics in the episodic symptoms associated to migraine

The main purpose of our study in the pediatric emergency unit of Nancy is to compare the presence of colics in infants and the presence of migraine in their parents to determine if colicky children's parents are more migrainous than other parents. The data collection will be made thanks to a survey which will be completed by the parents.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Gender: All
• Age group: 60 Days to 180 Days

Eligibility

Inclusion Criteria:

• All infants between 60 days and 180 days of life who comes to the Nancy University Hospital pediatric emergency unit

Exclusion Criteria:

• Language barrier of parents

Related Conditions & MeSH terms

• Colic
• Colic, Infantile
• Migraine
• Migraine Disorders
• Migraine Equivalents

Intervention

Other:
• Non interventional study
Non interventional study

Locations

Country	Name	City	State
France	Dr BORSA-DORION Anne	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of real colics according to Wessel definition		At the inclusion
Primary	Proportion of migrainous parents	Proportion of migrainous parents in each group	At the inclusion
Secondary	Proportion of Infant colics according the feeling parents		At the inclusion
Secondary	Proportion of maternal migraine		At the inclusion
Secondary	Proportion of partenal migraine		At the inclusion
Secondary	Age of begining of colics	average and median age	At the inclusion
Secondary	Age of ending of colics	average and median age	At the inclusion
Secondary	Proportion of real colics according to Wessel definition in the subgroup of parents who report that their child has colic		at the inclusion