NCT00248391

Brief Summary

Supine feeding position is associated with serous otitis media. The hypothesis is that supine feeding is associated with recurrent otitis media, tonsillar and adenoid hypertrophy and recurrent pneumonia secondary to recurrent aspiration.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

October 26, 2007

Status Verified

October 1, 2006

First QC Date

November 3, 2005

Last Update Submit

October 25, 2007

Conditions

Pulmonary DiseasesTonsillar HypertrophyOtitis MediaDental Caries

Keywords

adenoid hypertrophyfeeding positionsupineuprightpneumoniawheezingotitisadenoidtonsilcaries

Outcome Measures

Primary Outcomes (2)

  • pulmonary and ear-throat-nose morbidity

  • medical costs

    measured every 3 months

Interventions

upright feedingBEHAVIORAL

Eligibility Criteria

Age3 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Newborn
  • Mother's compliance

You may not qualify if:

  • Bronchopulmonary dysplasia (BPD)
  • Asthma
  • Cystic fibrosis
  • Heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, P.P.Box 12000, Israel

Location

MeSH Terms

Conditions

Lung DiseasesOtitis MediaDental CariesDeceptionPneumoniaRespiratory SoundsOtitis

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesEar DiseasesOtorhinolaryngologic DiseasesTooth DemineralizationTooth DiseasesStomatognathic DiseasesSocial BehaviorBehaviorRespiratory Tract InfectionsInfectionsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Avraham Avital, Prof

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Avraham Avital, Prof

CONTACT

972-2-6777782avital@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 4, 2005

Study Completion

January 1, 2008

Last Updated

October 26, 2007

Record last verified: 2006-10

Locations

IL(1)