Atopic DermatitisNCT04218877
The Factors Affecting Atopic Dermatitis in Children Age 1-3
An observational study of Atopic Dermatitis, run by Akusherstvo Pro at 1 site in Russia.
Trial summary
This study evaluates the influence of different triggers on atopic dermatitis manifestation in children under 3 years old. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- 10 Mar 2020to 10 Dec 2020
- 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 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients A Medclinic
Who may be able to join
- children 1-3 age without rash, without atopic dermatitis
- children 1-3 age with recurrent atopic dermatitis
Who cannot join
- children 1-3 age with non-specific rush
- children age 1-2 with atopic dermatitis without rush during previous year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trigger's Influence on Atopic Dermatitis Manifestation in Children Under 3 Years Old
This study evaluates the influence of different triggers on atopic dermatitis manifestation in children under 3 years old.
Read the detailed description
In this study investigators evaluate the influence of atopic dermatitis triggers before labour, right after labour, in firsts weeks after labour, in first year. Investigators want to find the most popular and most important factors witch provoke atopic dermatitis manifestation and comparison the results with children without atopic dermatitis but with genetic predisposition to it.
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
There will be no intervention, only observation
| Study group | Role | What they receive |
|---|---|---|
| Children with atopic dermatitis | Children 1-3 years old with atopic dermatitis | |
| Children without atopic dermatitis | Not described | |
| Children with genetic predisposition | Children with genetic predisposition to atopic dermatitis, but without manifestations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trigger's factors for atopic dermatitis
Vitamins during pregnancy; probiotics during pregnancy; school for future parents; vaginal birth; cesarian section; "golden hour" after delivery; antibiotics for mother and child right away after delivery; vaccination; breastfeeding; time after delivery for discharging hospital; using herbs for child's bathing; cosmetics for child; mother's diet after delivery; air's moisture; newborn's acne; pets; in what age child taste egg, cow's milk, fish, wheat, peanut, seafood; breastfeeding durations; infant formula in first year. All this factor will be aggregated as "yes" and "no"
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start10 Mar 2020
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akusherstvo Pro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218877
- Sponsor's protocol ID
- AkusherstvoPro
- Status last verified
- Feb 2022
- First submitted
- 30 Dec 2019
- Last updated
- 2 Feb 2022
- 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 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigger's Influence on Atopic Dermatitis Manifestation in Children Under 3 Years Old
- ClinicalTrials.gov ID
- NCT04218877
- Acronym / sponsor ID
- AkusherstvoPro
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Akusherstvo ProUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 6 Jan 2020 (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.
This study evaluates the influence of different triggers on atopic dermatitis manifestation in children under 3 years old.
Detailed description
In this study investigators evaluate the influence of atopic dermatitis triggers before labour, right after labour, in firsts weeks after labour, in first year. Investigators want to find the most popular and most important factors witch provoke atopic dermatitis manifestation and comparison the results with children without atopic dermatitis but with genetic predisposition to it.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children with atopic dermatitis | – | –Children 1-3 years old with atopic dermatitis |
| Children without atopic dermatitis | – | – |
| Children with genetic predisposition | – | –Children with genetic predisposition to atopic dermatitis, but without manifestations |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients A Medclinic
Key inclusion criteria (2 listed)
- children 1-3 age without rash, without atopic dermatitis
- children 1-3 age with recurrent atopic dermatitis
Key exclusion criteria (2 listed)
- children 1-3 age with non-specific rush
- children age 1-2 with atopic dermatitis without rush during previous year
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 |
|---|---|---|
| There will be no intervention, only observation | Other | Children with atopic dermatitis, Children with genetic predisposition, Children without atopic dermatitis |
Primary outcome
Trigger's factors for atopic dermatitis
Time frame: 3 years
Vitamins during pregnancy; probiotics during pregnancy; school for future parents; vaginal birth; cesarian section; "golden hour" after delivery; antibiotics for mother and child right away after delivery; vaccination; breastfeeding; time after delivery for discharging hospital; using herbs for child's bathing; cosmetics for child; mother's diet after delivery; air's moisture; newborn's acne; pets; in what age child taste egg, cow's milk, fish, wheat, peanut, seafood; breastfeeding durations; infant formula in first year. All this factor will be aggregated as "yes" and "no"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atopic Dermatitis, run by Akusherstvo Pro at 1 site in Russia.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 2 Feb 2022. 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trigger's factors for atopic dermatitis (time frame: 3 years). 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 2 Feb 2022.