Colic, InfantileCOLIGRAINENCT03155360
Infants Colics : Towards a Migrainous Origin ?
An observational study of Colic, Infantile and Migraine, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 60 to 180 days
- Conditions the study is for
- Colic, Infantile, Migraine, Migraine Equivalents
- What is being tested?
- Non interventional study
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2017to 1 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 180 days
- All sexes
- Child
Study population: All infants between 60 days and 180 days of life who comes to the Nancy University Hospital pediatric emergency unit
Who may be able to join
- All infants between 60 days and 180 days of life who comes to the Nancy University Hospital pediatric emergency unit
Who cannot join
- Language barrier of parents
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Dr BORSA-DORION Anne
Nancy, 54500
François BREZIN
About this study
Official title: 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.
Read the 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.
- Conditions
- Colic, Infantile, Migraine, Migraine Equivalents
- Being tested
- Non interventional study
- Keywords
- Colics, infant colics, Migraine equivalent, Migraine, Episodic symptoms associated to migraine, Colic
- Medical subject headings
- Colic, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
Non interventional study
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Non interventional study | |
| Infant without colics | Not described Receives: Other: Non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of real colics according to Wessel definition
Measured: At the inclusion
Proportion of migrainous parents
Proportion of migrainous parents in each group
Measured: At the inclusion
Secondary outcomes (6)
Proportion of Infant colics according the feeling parents
Measured: At the inclusion
Proportion of maternal migraine
Measured: At the inclusion
Proportion of partenal migraine
Measured: At the inclusion
Age of begining of colics
average and median age
Measured: At the inclusion
Age of ending of colics
average and median age
Measured: At the inclusion
Proportion of real colics according to Wessel definition in the subgroup of parents who report that their child has colic
Measured: at the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start18 May 2017
- Primary completion1 Nov 2017 (estimated)
- Study completion1 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colic, InfantileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155360
- Sponsor's protocol ID
- 2017-A00185-48
- Acronym
- COLIGRAINE
- Status last verified
- Aug 2017
- First submitted
- 15 May 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Infant Colics and Parental Migraine ? Non Interventional Study in the Pediatric Emergency Unit of Nancy (France) University Hospital
- ClinicalTrials.gov ID
- NCT03155360
- Acronym / sponsor ID
- COLIGRAINE / 2017-A00185-48
- Conditions
- Colic, Infantile, Migraine, Migraine Equivalents
- Keywords
- Colics, infant colics, Migraine equivalent, Migraine, Episodic symptoms associated to migraine, Colic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 18 May 2017 (actual)
- Primary completion
- 1 Nov 2017 (estimated)
- Study completion
- 1 Nov 2017 (estimated)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant with colics | – | Other: Non interventional studyInfants 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 |
| Infant without colics | – | Other: Non interventional study |
Who may qualify
- Ages
- 60 to 180 days
- Sex
- All
- Age groups
- Child
- Study population
- All infants between 60 days and 180 days of life who comes to the Nancy University Hospital pediatric emergency unit
Key inclusion criteria (1 listed)
- All infants between 60 days and 180 days of life who comes to the Nancy University Hospital pediatric emergency unit
Key exclusion criteria (1 listed)
- Language barrier of parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventional studyNon interventional study | Other | Infant with colics, Infant without colics |
Primary outcome
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
6 secondary outcomes
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
Age of ending of colics
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colic, Infantile and Migraine, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François BREZIN (00 33 6 63 78 08 87, francois.brezin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of real colics according to Wessel definition (time frame: At the inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.