Delayed Language in Cleft PalateNCT06151340
Delayed Language Development in Children With Cleft Palate at Sohag University Hospital
An observational study of Delayed Language in Cleft Palate, run by Sohag University at 1 site in Egypt.
Trial summary
This is a retrospective study on children with cleft palate who came to the multidisciplinary cleft clinic at Sohag University Hospital from September 2017 to September 2023 Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Delayed Language in Cleft Palate
- What is being tested?
- Data collection
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 1 Sep 2023
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: cleft palate children
Who may be able to join
- cleft palate children's
Who cannot join
- cleft lip only
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective study on children with cleft palate who came to the multidisciplinary cleft clinic at Sohag University Hospital from September 2017 to September 2023
- Conditions
- Delayed Language in Cleft Palate
- Being tested
- Data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation analysis between IQ with degree of delayed language in children with cleft palate (CCP).
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Sep 2017
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Language in Cleft PalateStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeel Ezeldin Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151340
- Sponsor's protocol ID
- Soh-Med-23-11-06MS
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 30 Nov 2023
- 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 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Language Development in Children With Cleft Palate at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06151340
- Acronym / sponsor ID
- Soh-Med-23-11-06MS
- Conditions
- Delayed Language in Cleft Palate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 30 Nov 2023 (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 is a retrospective study on children with cleft palate who came to the multidisciplinary cleft clinic at Sohag University Hospital from September 2017 to September 2023
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- cleft palate children
Key inclusion criteria (1 listed)
- cleft palate children's
Key exclusion criteria (1 listed)
- cleft lip only
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 |
|---|---|---|
| Data collectionData collection | Other | – |
Primary outcome
Correlation analysis between IQ with degree of delayed language in children with cleft palate (CCP).
Time frame: 6 years
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 30 Nov 2023.
- Individual participant dataSharing planned: No
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 Delayed Language in Cleft Palate, run by Sohag University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 30 Nov 2023. 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 Egypt. 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?
Correlation analysis between IQ with degree of delayed language in children with cleft palate (CCP). (time frame: 6 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 30 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.