NCT02040688

Brief 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. 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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

3.3 years

First QC Date

January 9, 2014

Last Update Submit

January 15, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of sleep disorders using Brief Infant Sleep Questionnaire (BISQ) and feeding disorders using the Behavioral Pediatrics Feeding Assessment.

    Imidietly after the questionnaire filled by the parent.

Study Arms (3)

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.

Eligibility Criteria

Age7 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • Children with
  • Chronic medical conditions.
  • Congenital abnormalities.
  • Significant developmental delay.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Sleep Center at Dana Children's hospital

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Sudden Infant DeathFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Death, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsInfant DeathSigns and Symptoms, DigestiveSigns and SymptomsMental Disorders

Central Study Contacts

Riva Tauman, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 20, 2014

Study Start

August 1, 2011

Primary Completion

November 1, 2014

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations