ColicCOLONECHOGENENCT04983069
Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity
An observational study of Colic and Nephropathy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Fetal colic hyper-echogenicity is a presenting symptoms for cystinuria lysinuria. A few cases of fetuses with dibasic protein intolerance (more complex prognosis) presented with colic hyper-echogenicity antenatal. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Colic, Nephropathy
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 1 May 2022
- 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 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Foetuses with prenatal colic hyperechogenicity
Who may be able to join
- Fetuses with prenatal colic hyperechogenicity
- Between January 2011 and January 2021
- Born without term limitation.
Who cannot join
- Intestinal hyperechogenicity
- polymalformative syndrome
- Patients Age<15 years
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Florent Fuchs, PhD, f-fuchs@chu-montpellier.fr
Alexis RODRIGUEZ, 668591043 ext. 33, alexis-rodriguez@chu-montpellier.fr
About this study
Fetal colic hyper-echogenicity is a presenting symptoms for cystinuria lysinuria.
A few cases of fetuses with dibasic protein intolerance (more complex prognosis) presented with colic hyper-echogenicity antenatal.
The aim of this retrospective study is to assess the outcome of fetuses with colic hyperechogenicity in order to increase prenatal counseling
Read the detailed description
Observational multicenter retrospective study from january 2011 to january 2021.
No supplementary visit, directly related to the research, will be necessary. This study does not change the usual management of the patient.
Patients will be included after their usual medical check-up.
- Conditions
- Colic, Nephropathy
- Keywords
- Gynecology-Obstetrics, Ultrasound, Medical genetics, Pediatrics, Nephropathy, Colic hyperechogenicity, Antenatal, Lysinuria-cystinuria, lysinuric protein intolerance
- Medical subject headings
- Colic, Kidney Diseases, Lysinuric Protein Intolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
Postnatal outcome of fetuses
Postnatal outcome of fetuses with hyperechogenic colon.
Measured: day 1 (End of follow up)
Secondary outcomes (2)
Rate of lysinuria/cystinuria
Rate of lysinuria/cystinuria
Measured: day 1 (End of follow up)
Rate of dibasic protein intolerance
Rate of dibasic protein intolerance
Measured: day 1 (End of follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Jul 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColicStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent FUCHS, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983069
- Sponsor's protocol ID
- RECHMPL21_0376
- Acronym
- COLONECHOGENE
- Status last verified
- Nov 2021
- First submitted
- 5 Jul 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity
- ClinicalTrials.gov ID
- NCT04983069
- Acronym / sponsor ID
- COLONECHOGENE / RECHMPL21_0376
- Conditions
- Colic, Nephropathy
- Keywords
- Gynecology-Obstetrics, Ultrasound, Medical genetics, Pediatrics, Nephropathy, Colic hyperechogenicity, Antenatal, Lysinuria-cystinuria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 30 Jul 2021 (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.
Fetal colic hyper-echogenicity is a presenting symptoms for cystinuria lysinuria.
A few cases of fetuses with dibasic protein intolerance (more complex prognosis) presented with colic hyper-echogenicity antenatal.
The aim of this retrospective study is to assess the outcome of fetuses with colic hyperechogenicity in order to increase prenatal counseling
Detailed description
Observational multicenter retrospective study from january 2011 to january 2021.
No supplementary visit, directly related to the research, will be necessary. This study does not change the usual management of the patient.
Patients will be included after their usual medical check-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Foetuses with prenatal colic hyperechogenicity
Key inclusion criteria (3 listed)
- Fetuses with prenatal colic hyperechogenicity
- Between January 2011 and January 2021
- Born without term limitation.
Key exclusion criteria (3 listed)
- Intestinal hyperechogenicity
- polymalformative syndrome
- Patients Age<15 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postnatal outcome of fetuses
Time frame: day 1 (End of follow up)
Postnatal outcome of fetuses with hyperechogenic colon.
2 secondary outcomes
Rate of lysinuria/cystinuria
Time frame: day 1 (End of follow up)
Rate of dibasic protein intolerance
Time frame: day 1 (End of follow up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Colic
RecruitingPhase 3
Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED
Renal Colic
Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
Active, not recruiting
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Infantile Colic
Recruiting
Contribution of Preserving the Superior Left Colic Artery to the Vascularization of the Descending Colon Prior to Colorectal Anastomosis During Left-Sided or Rectal Resections for Colorectal or Ovarian Cancer. (Revascularisation Colique)
Rectal Cancer, Colon Cancer
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic
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.
Florent FUCHS, PhD principal investigator
University Hospital, Montpellier
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 and Nephropathy, run by University Hospital, Montpellier 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 3 inclusion and 3 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 15 Nov 2021. 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 Florent FUCHS, PhD (04 67 33 09 80 ext. 33, f-fuchs@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postnatal outcome of fetuses (time frame: day 1 (End of follow up)). 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 15 Nov 2021.