Pulmonary DiseasesNCT00248391
The Influence of Feeding Position on Pulmonary Morbidity in Young Children
A study testing upright feeding in people with Pulmonary Diseases and Tonsillar Hypertrophy, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Diseases, Tonsillar Hypertrophy, Otitis Media
- What is being tested?
- upright feeding
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento Jan 2008
- Phase
- Interventional
- 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 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborn
- Mother's compliance
Who cannot join
- Bronchopulmonary dysplasia (BPD)
- Asthma
- Cystic fibrosis
- Heart disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, P.P.Box 12000
Avraham Avital, Prof, 972-2-6777782, avital@hadassah.org.il
About this study
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.
Read the detailed description
The aim of the study is to compare two "mother and child health clinic" stations with similar socioeconomic background. Mothers from the study station will be instructed to feed their children only in an upright position since birth. In the control station mothers will continue to feed their children as usual. Pulmonary morbidity will be evaluated prospectively through the computer system of the insurance companies.
- Conditions
- Pulmonary Diseases, Tonsillar Hypertrophy, Otitis Media, Dental Caries
- Being tested
- upright feeding
- Keywords
- adenoid hypertrophy, feeding position, supine, upright, pneumonia, wheezing, otitis, adenoid, tonsil, caries
- Medical subject headings
- Lung Diseases, Otitis Media, Dental Caries, Deception, Pneumonia, Respiratory Sounds, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upright feedingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary and ear-throat-nose morbidity
medical costs
Measured: measured every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study completionJan 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseasesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Avraham Avital, Prof, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248391
- Sponsor's protocol ID
- avitalbotlitis- HMO-CTIL
- Other IDs
- no grant meanwhile
- Status last verified
- Oct 2006
- First submitted
- 3 Nov 2005
- Last updated
- 26 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Feeding Position on Pulmonary Morbidity in Young Children
- ClinicalTrials.gov ID
- NCT00248391
- Acronym / sponsor ID
- avitalbotlitis- HMO-CTIL
- Conditions
- Pulmonary Diseases, Tonsillar Hypertrophy, Otitis Media, Dental Caries
- Keywords
- adenoid hypertrophy, feeding position, supine, upright, pneumonia, wheezing, otitis, adenoid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study completion
- Jan 2008 (estimated)
- First posted
- 4 Nov 2005 (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.
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.
Detailed description
The aim of the study is to compare two "mother and child health clinic" stations with similar socioeconomic background. Mothers from the study station will be instructed to feed their children only in an upright position since birth. In the control station mothers will continue to feed their children as usual. Pulmonary morbidity will be evaluated prospectively through the computer system of the insurance companies.
Study design
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborn
- Mother's compliance
Key exclusion criteria (4 listed)
- Bronchopulmonary dysplasia (BPD)
- Asthma
- Cystic fibrosis
- Heart disease
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 |
|---|---|---|
| upright feeding | Behavioural | – |
Primary outcome
pulmonary and ear-throat-nose morbidity
medical costs
Time frame: measured every 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2007.
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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.
Avraham Avital, Prof principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upright feeding in people with Pulmonary Diseases and Tonsillar Hypertrophy, run by Hadassah Medical Organization 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 2 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 26 Oct 2007. 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 Avraham Avital, Prof (972-2-6777782, avital@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary and ear-throat-nose morbidity. The study lists 2 primary outcomes in all. 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 26 Oct 2007.