We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Infants Colics : Towards a Migrainous Origin ? (COLIGRAINE)

This study is currently recruiting participants.
Verified August 2017 by Central Hospital, Nancy, France
Sponsor:
ClinicalTrials.gov Identifier:
NCT03155360
First Posted: May 16, 2017
Last Update Posted: August 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Central Hospital, Nancy, France
  Purpose
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.

Condition Intervention
Colic, Infantile Migraine Migraine Equivalents Other: Non interventional study

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Association Between Infant Colics and Parental Migraine ? Non Interventional Study in the Pediatric Emergency Unit of Nancy (France) University Hospital

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • Proportion of real colics according to Wessel definition [ Time Frame: At the inclusion ]
  • Proportion of migrainous parents [ Time Frame: At the inclusion ]
    Proportion of migrainous parents in each group


Secondary Outcome Measures:
  • Proportion of Infant colics according the feeling parents [ Time Frame: At the inclusion ]
  • Proportion of maternal migraine [ Time Frame: At the inclusion ]
  • Proportion of partenal migraine [ Time Frame: At the inclusion ]
  • Age of begining of colics [ Time Frame: At the inclusion ]
    average and median age

  • Age of ending of colics [ Time Frame: At the inclusion ]
    average and median age

  • 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 ]

Estimated Enrollment: 300
Actual Study Start Date: May 18, 2017
Estimated Study Completion Date: November 1, 2017
Estimated Primary Completion Date: November 1, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Days to 180 Days   (Child)
Sexes 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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155360


Contacts
Contact: François BREZIN 00 33 6 63 78 08 87 francois.brezin@gmail.com
Contact: Anne BORSA-DORION 00 33 3 83 15 47 33 a.borsa-dorion@chru-nancy.fr

Locations
France
Dr BORSA-DORION Anne Recruiting
Nancy, France, 54500
Contact: François BREZIN         
Sponsors and Collaborators
Central Hospital, Nancy, France
  More Information

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03155360     History of Changes
Other Study ID Numbers: 2017-A00185-48
First Submitted: May 15, 2017
First Posted: May 16, 2017
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Central Hospital, Nancy, France:
Colics
infant colics
Migraine equivalent
Migraine
Episodic symptoms associated to migraine
Colic

Additional relevant MeSH terms:
Migraine Disorders
Colic
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Infant, Newborn, Diseases