Infants Colics : Towards a Migrainous Origin ? (COLIGRAINE)

August 8, 2017 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54500
        • Recruiting
        • Dr BORSA-DORION Anne
        • Contact:
          • François BREZIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 5 months (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infant with colics

Infants with colics according to Wessel definition :

  • Recurrent episodes of irritability, fussing or crying from birth to 4 months of age
  • Episodes last for 3 hours per day ; on 3 days per week ; for 3 weeks
  • Episodes can not be attributed to another disorder
Other: Non interventional study
Non interventional study
Infant without colics
Other: Non interventional study
Non interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of real colics according to Wessel definition
Time Frame: At the inclusion
At the inclusion
Proportion of migrainous parents
Time Frame: At the inclusion
Proportion of migrainous parents in each group
At the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Infant colics according the feeling parents
Time Frame: At the inclusion
At the inclusion
Proportion of maternal migraine
Time Frame: At the inclusion
At the inclusion
Proportion of partenal migraine
Time Frame: At the inclusion
At the inclusion
Age of begining of colics
Time Frame: At the inclusion
average and median age
At the inclusion
Age of ending of colics
Time Frame: At the inclusion
average and median age
At the inclusion
Proportion of real colics according to Wessel definition in the subgroup of parents who report that their child has colic
Time Frame: at the inclusion
at the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 18, 2017

Primary Completion (ANTICIPATED)

November 1, 2017

Study Completion (ANTICIPATED)

November 1, 2017

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (ACTUAL)

May 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A00185-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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