NCT03155360

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

May 18, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

May 15, 2017

Last Update Submit

August 8, 2017

Conditions

Colic, InfantileMigraineMigraine Equivalents

Keywords

Colicsinfant colicsMigraine equivalentMigraineEpisodic symptoms associated to migraineColic

Outcome Measures

Primary Outcomes (2)

  • Proportion of real colics according to Wessel definition

    At the inclusion

  • Proportion of migrainous parents

    Proportion of migrainous parents in each group

    At the inclusion

Secondary Outcomes (6)

  • Proportion of Infant colics according the feeling parents

    At the inclusion

  • Proportion of maternal migraine

    At the inclusion

  • Proportion of partenal migraine

    At the inclusion

  • Age of begining of colics

    At the inclusion

  • Age of ending of colics

    At the inclusion

  • +1 more secondary outcomes

Study Arms (2)

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

Infant without colics

Other: Non interventional study

Interventions

Non interventional studyOTHER

Non interventional study

Infant with colicsInfant without colics

Eligibility Criteria

Age60 Days - 180 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Language barrier of parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr BORSA-DORION Anne

Nancy, 54500, France

RECRUITING

MeSH Terms

Conditions

ColicMigraine Disorders

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

François BREZIN

CONTACT

00 33 6 63 78 08 87francois.brezin@gmail.com

Anne BORSA-DORION

CONTACT

00 33 3 83 15 47 33a.borsa-dorion@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 16, 2017

Study Start

May 18, 2017

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

August 9, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)