Child BehaviorNNSHNCT03054493
Prevalence of NNSH in a Group of Egyptian Children Aged 3-8 Years Old in Giza Governorate: A Cross Sectional Study.
An observational study of Child Behavior, run by Cairo University at 1 site in Egypt.
Trial summary
1. Prevalence of non-nutritive sucking habits (NNSH) in a group of Egyptian children aged 3-8 years old in Giza Governorate. 2. Assessment of factors associated with NNSH. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Child Behavior
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,023 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2017to Mar 2018
- 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 3 to 8 years
- All sexes
- Child
Study population: A group of Egyptian children aged 3-8 years in Giza Governorate.
Who may be able to join
- 3-8 years old children.
- Children free of systemic diseases.
- Positive patient/parents acceptance for participation in the study.
- Both sexes will be included.
Who cannot join
- Disabled children.
- Children with cleft lip \& palate.
- TMJ disorders.
- Children undergoing orthodontic/orthopedic treatment.
- Participants who were exposed to thumb sucking prevention programs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Non-Nutritive Sucking Habits in a Group of Egyptian Children Aged 3-8 Years Old in Giza Governorate: A Cross Sectional Study.
- Prevalence of non-nutritive sucking habits (NNSH) in a group of Egyptian children aged 3-8 years old in Giza Governorate.
- Assessment of factors associated with NNSH.
Read the detailed description
Several studies have reported on the prevalence of non-nutritive sucking behaviors among infants and young children in different populations. Non-nutritive sucking is regarded as a normal part of development, and early studies of its prevalence generally found that 70-90% of children had some history of a non-nutritive sucking habit. Like these early studies, most recent studies have used retrospective methods to assess the prevalence of non-nutritive sucking habits.
Prolonged duration of non-nutritive sucking behaviors may have consequences in regard to the developing orofacial structures and occlusion. Little is known as to why some children have sucking habits beyond the first 2 to 3 years of life.
Prevalence of NNSH and associated factors in Egyptian children might be different.
- Conditions
- Child Behavior
- Being tested
- no intervention
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionBehavioural
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
non-nutritive sucking habits
child sucking one or more of his/her digits and/or object beyond 36 months old.
Measured: 20 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start10 Feb 2017
- Primary completionJun 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afnan Mohammad Nassar, Cairo University
- Investigators
- Afnan Mo Nassar, Bechlor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054493
- Sponsor's protocol ID
- AMNassar
- Acronym
- NNSH
- Status last verified
- Feb 2017
- First submitted
- 11 Feb 2017
- Last updated
- 16 Feb 2017
- Results posted
- No
- Individual data sharing
- No
Publications
de Holanda AL, dos Santos SA, Fernandes de Sena M, Ferreira MA. Relationship between breast- and bottle-feeding and non-nutritive sucking habits. Oral Health Prev Dent. 2009;7(4):331-7.
PubMed 20011750Maia-Nader M, Silva de Araujo Figueiredo C, Pinheiro de Figueiredo F, Moura da Silva AA, Thomaz EB, Saraiva MC, Barbieri MA, Bettiol H. Factors associated with prolonged non-nutritive sucking habits in two cohorts of Brazilian children. BMC Public Health. 2014 Jul 22;14:743. doi: 10.1186/1471-2458-14-743.
PubMed 25053157Medeiros AP, Ferreira JT, Felicio CM. Correlation between feeding methods, non-nutritive sucking and orofacial behaviors. Pro Fono. 2009 Oct-Dec;21(4):315-9. doi: 10.1590/s0104-56872009000400009.
PubMed 20098950
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Non-Nutritive Sucking Habits in a Group of Egyptian Children Aged 3-8 Years Old in Giza Governorate: A Cross Sectional Study.
- ClinicalTrials.gov ID
- NCT03054493
- Acronym / sponsor ID
- NNSH / AMNassar
- Conditions
- Child Behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,023 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 15 Feb 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.
- Prevalence of non-nutritive sucking habits (NNSH) in a group of Egyptian children aged 3-8 years old in Giza Governorate.
- Assessment of factors associated with NNSH.
Detailed description
Several studies have reported on the prevalence of non-nutritive sucking behaviors among infants and young children in different populations. Non-nutritive sucking is regarded as a normal part of development, and early studies of its prevalence generally found that 70-90% of children had some history of a non-nutritive sucking habit. Like these early studies, most recent studies have used retrospective methods to assess the prevalence of non-nutritive sucking habits.
Prolonged duration of non-nutritive sucking behaviors may have consequences in regard to the developing orofacial structures and occlusion. Little is known as to why some children have sucking habits beyond the first 2 to 3 years of life.
Prevalence of NNSH and associated factors in Egyptian children might be different.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Age groups
- Child
- Study population
- A group of Egyptian children aged 3-8 years in Giza Governorate.
Key inclusion criteria (4 listed)
- 3-8 years old children.
- Children free of systemic diseases.
- Positive patient/parents acceptance for participation in the study.
- Both sexes will be included.
Key exclusion criteria (5 listed)
- Disabled children.
- Children with cleft lip \& palate.
- TMJ disorders.
- Children undergoing orthodontic/orthopedic treatment.
- Participants who were exposed to thumb sucking prevention programs.
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 |
|---|---|---|
| no interventionno intervention | Behavioural | – |
Primary outcome
non-nutritive sucking habits
Time frame: 20 mins
child sucking one or more of his/her digits and/or object beyond 36 months old.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Background: PubMed 20011750de Holanda AL, dos Santos SA, Fernandes de Sena M, Ferreira MA. Relationship between breast- and bottle-feeding and non-nutritive sucking habits. Oral Health Prev Dent. 2009;7(4):331-7.
- Background: PubMed 25053157Maia-Nader M, Silva de Araujo Figueiredo C, Pinheiro de Figueiredo F, Moura da Silva AA, Thomaz EB, Saraiva MC, Barbieri MA, Bettiol H. Factors associated with prolonged non-nutritive sucking habits in two cohorts of Brazilian children. BMC Public Health. 2014 Jul 22;14:743. doi: 10.1186/1471-2458-14-743.
- Background: PubMed 20098950Medeiros AP, Ferreira JT, Felicio CM. Correlation between feeding methods, non-nutritive sucking and orofacial behaviors. Pro Fono. 2009 Oct-Dec;21(4):315-9. doi: 10.1590/s0104-56872009000400009.
- Individual participant dataSharing planned: No
Related trials for Child Behavior
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
Study of Psychoeducation and Reading for Kids (SPARK)
Reading Difficulties, Behavioral Problems
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.
Afnan Mo Nassar, Bechlor principal investigator
Cairo University
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 Child Behavior, run by Cairo 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 4 inclusion and 5 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 16 Feb 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 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?
Results are not available in the source record.
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?
non-nutritive sucking habits (time frame: 20 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03054493, which also lists 3 linked publications.
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 16 Feb 2017.