Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03155360
Other study ID # 2017-A00185-48
Secondary ID
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05525611 - Cabergoline as a Preventive Treatment for Chronic Migraine N/A
Completed NCT06192173 - Patent Foramen Ovale Closure in Migraine
Recruiting NCT03832998 - Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine Phase 3
Enrolling by invitation NCT04196933 - Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma N/A
Not yet recruiting NCT06428838 - Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context Phase 3
Completed NCT06304675 - Manageable Environmental Factors in Migraine
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Recruiting NCT05517200 - Pilot Study for a Machine Learning Test for Migraine
Completed NCT04179474 - Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine Phase 1
Recruiting NCT04603976 - Registry for Migraine - Clinical Core Phase 4
Completed NCT03597529 - CHOCOlate MeLatonin for AdolescenT MigrainE Phase 2
Completed NCT04197349 - Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman Phase 1
Recruiting NCT05891808 - miR-155 Expression in Episodic and Chronic Migraine
Active, not recruiting NCT05064371 - Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan Phase 3
Suspended NCT04069572 - Vibratory Stimulation for the Treatment of Chronic Pain N/A
Not yet recruiting NCT04859374 - Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach N/A
Not yet recruiting NCT03083860 - Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions. N/A
Completed NCT02905227 - A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder Phase 1
Enrolling by invitation NCT02532023 - The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients Phase 4
Completed NCT02108678 - One-Day Intervention for Depression and Impairment in Migraine Patients N/A