SIDNCT02040688
Sensory Integration (Processing) Disorder Among Children With Behavioral Insomnia and Children With Feeding Disorder
An observational study of SID and Feeding Disorder, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Behavioral insomnia of childhood is a prevalent condition, affecting 10-30% of children 6-36 months of age. If left untreated, bedtime problems and night wakings can negatively impact the daytime functioning and behavior of the child, as well as the entire family. Read more about this study
- Who is it for?
- Ages 7 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- SID, Feeding Disorder, SPD
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Nov 2014
- 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 7 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 7-36 months old children will be selected from: * The clinic of feeding disorders at Dana Children's Hospital. * The Pediatric Sleep Center at Dana Children's hospital * Well-care clinics in the metropolitan of Tel Aviv
Who may be able to join
- children 7-36 months of age with behavioral insomnia of childhood based on the International Classification of Sleep Disorders (ICSD) criteria .
- children 7-36 months of age with feeding disorders based on Chatoor criteria.
- children 7-36 months of age who attend well-care clinics in the metropolitan of Tel Aviv for routine periodic medical examination.
Who cannot join
- Children with
- Chronic medical conditions.
- Congenital abnormalities.
- Significant developmental delay.
Trial locations and contacts
1 site in 1 country.
Riva Tauman, Dr. contact
Israel1 site, 1 recruiting
- Recruiting
Pediatric Sleep Center at Dana Children's hospital
Tel Aviv
Riva Tauman, Dr., tauman@tlvmc.gov.il
Riva Tauman, Dr.
About this study
Behavioral insomnia of childhood is a prevalent condition, affecting 10-30% of children 6-36 months of age. If left untreated, bedtime problems and night wakings can negatively impact the daytime functioning and behavior of the child, as well as the entire family.
Feeding difficulties are common in pediatric practice and encompass a spectrum ranging from children with physiological difficulties in ingesting food, through picky eaters to full fledged infantile feeding disorders.
Read more
We have recently shown that feeding and eating difficulties are more prevalent among children with behavioral insomnia of childhood and that sleep problems are more frequent in children with feeding disorders.
We hypotesize that SPD is a common etiology for both sleep and feeding disorders and that children with sleep or feeding disorder have increased rate of Sensory intergration disorder (SID) compared with healthy controls.
- Conditions
- SID, Feeding Disorder, SPD
- Medical subject headings
- Sudden Infant Death, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Disorders | 7-36 months old children with behavioral insomnia of childhood based on the International Classification of Sleep Disorders (ICSD) criteria will be recruited from the Pediatric Sleep Center at Dana Children's hospital | |
| Control | 7-36 months old chidren of age who attend well-care clinics in the metropolitan of Tel Aviv for routine periodic medical examination. | |
| Feeding disorder | 7-36 monthsold children with feeding disorders based on Chatoor criteria will be recruited from the clinic of feeding disorders at Dana Children's Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sleep disorders using Brief Infant Sleep Questionnaire (BISQ) and feeding disorders using the Behavioral Pediatrics Feeding Assessment.
Measured: Imidietly after the questionnaire filled by the parent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startAug 2011
- Primary completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SIDStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040688
- Sponsor's protocol ID
- TASMC-11-RT-0471-11-CTIL
- Status last verified
- Jan 2014
- First submitted
- 9 Jan 2014
- Last updated
- 20 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Integration (Processing) Disorder Among Children With Behavioral Insomnia and Children With Feeding Disorder
- ClinicalTrials.gov ID
- NCT02040688
- Acronym / sponsor ID
- TASMC-11-RT-0471-11-CTIL
- Conditions
- SID, Feeding Disorder, SPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2011
- Primary completion
- Nov 2014 (estimated)
- First posted
- 20 Jan 2014 (estimated)
- 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.
Behavioral insomnia of childhood is a prevalent condition, affecting 10-30% of children 6-36 months of age. If left untreated, bedtime problems and night wakings can negatively impact the daytime functioning and behavior of the child, as well as the entire family.
Feeding difficulties are common in pediatric practice and encompass a spectrum ranging from children with physiological difficulties in ingesting food, through picky eaters to full fledged infantile feeding disorders.
We have recently shown that feeding and eating difficulties are more prevalent among children with behavioral insomnia of childhood and that sleep problems are more frequent in children with feeding disorders.
We hypotesize that SPD is a common etiology for both sleep and feeding disorders and that children with sleep or feeding disorder have increased rate of Sensory intergration disorder (SID) compared with healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sleep Disorders | – | –7-36 months old children with behavioral insomnia of childhood based on the International Classification of Sleep Disorders (ICSD) criteria will be recruited from the Pediatric Sleep Center at Dana Children's hospital |
| Control | – | –7-36 months old chidren of age who attend well-care clinics in the metropolitan of Tel Aviv for routine periodic medical examination. |
| Feeding disorder | – | –7-36 monthsold children with feeding disorders based on Chatoor criteria will be recruited from the clinic of feeding disorders at Dana Children's Hospital. |
Who may qualify
- Ages
- 7 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 7-36 months old children will be selected from: * The clinic of feeding disorders at Dana Children's Hospital. * The Pediatric Sleep Center at Dana Children's hospital * Well-care clinics in the metropolitan of Tel Aviv
Key inclusion criteria (3 listed)
- children 7-36 months of age with behavioral insomnia of childhood based on the International Classification of Sleep Disorders (ICSD) criteria .
- children 7-36 months of age with feeding disorders based on Chatoor criteria.
- children 7-36 months of age who attend well-care clinics in the metropolitan of Tel Aviv for routine periodic medical examination.
Key exclusion criteria (4 listed)
- Children with
- Chronic medical conditions.
- Congenital abnormalities.
- Significant developmental delay.
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
Evaluation of sleep disorders using Brief Infant Sleep Questionnaire (BISQ) and feeding disorders using the Behavioral Pediatrics Feeding Assessment.
Time frame: Imidietly after the questionnaire filled by the parent.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
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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.
Riva Tauman, Dr. contact
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 SID and Feeding Disorder, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 4 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 20 Jan 2014. 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 Israel. 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 Riva Tauman, Dr. (tauman@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of sleep disorders using Brief Infant Sleep Questionnaire (BISQ) and feeding disorders using the Behavioral Pediatrics Feeding Assessment. (time frame: Imidietly after the questionnaire filled by the parent.). 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 20 Jan 2014.