Adenoid HypertrophyNCT04431128
Adenoid Hypertrophy, Respiratory Complications and Correlation With Infant Feeding Position
An observational study of Adenoid Hypertrophy, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
500 children aged 0-5 years followed since birth by Principal Investigator (PI)since January1, 2003 till December 31, 2018 and diagnosed with adenoid hypertrophy (AH) (study group) and 500 children aged 0-5 years followed by principal investigator during the same years and diagnosed as urinary tract infection (UTI)… Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Adenoid Hypertrophy
- What is being tested?
- infant feeding position
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2003to 6 Jun 2020
- 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 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Young infants followed since birth or from the first half of the first year of life, followed at least for 5 years by PI, study group (till 500 children) with the diagnosis of AH, control group (till 500 children) diagnosed as UTI, GE, vomiting or diarrhea and without AH.
Inclusion Criteria: Study group: Young children with diagnosis of adenoid hypertrophy followed by PI Control group: young children with diagnosis of UTI, GE, vomiting or diarrhea followed by PI
Exclusion Criteria: Children with cystic fibrosis, primary dyskinesia, immune deficiency, congenital anatomical malformations of nasal or airway passages.
Children older than 6 months of age when starting to be followed by PI.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, P.P.Box 12000
About this study
Official title: Adenoid Hypertrophy, Etiology, Clinical Manifestations and Related Morbidity, Correlation With Infant Feeding Position
500 children aged 0-5 years followed since birth by Principal Investigator (PI)since January1, 2003 till December 31, 2018 and diagnosed with adenoid hypertrophy (AH) (study group) and 500 children aged 0-5 years followed by principal investigator during the same years and diagnosed as urinary tract infection (UTI), gastroenteritis (GE), diarrhea, vomiting but without AH (control group) were compared. Morbidity and treatment will be compared and correlated with gastro-esophageal reflux (GER), allergy and infant feeding position during the first few years of life in the two groups.
Read the detailed description
The 2 groups are children aged 0-5 years and treated by PI and followed since birth during years 2003-2018. Study group consists of children diagnosed at least 2 times as AH and control group as similar children with UTI, GE, vomiting or diarrhea. Respiratory problems (pneumonia, bronchopneumonia, bronchitis), ear problems (otitis media OM, serous OM), antibiotic treatment, use of bronchodilators, inhaled corticosteroid (ICS), chest X-rays, anomalous laboratory results, emergency room visits and hospitalization rates will be compared in the two groups, together with details concerning feeding position during the first years of life. Correlation between morbidity, degree of nasopharyngeal obstruction, allergy, GER and supine feeding position, will be evaluated.
- Conditions
- Adenoid Hypertrophy
- Being tested
- infant feeding position
- Keywords
- Adenoid hypertrophy, Allergy, Infant Feeding Position, GER, Pneumonia, Bronchitis, Otitis
- Medical subject headings
- Hypersensitivity, Pneumonia, Bronchitis, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infant feeding positionBehavioural
correlation with allergy, GER or feeding position
| Study group | Role | What they receive |
|---|---|---|
| study group | Adenoid hypertrophy Receives: Behavioral: infant feeding position | |
| Control group | UTI, GE, vomiting, diarrhea Receives: Behavioral: infant feeding position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory complications
Number of participants with Pneumonia, bronchitis
Measured: 3 years
Ear complications
Number of participants with otitis media, serous otitis media
Measured: 3 years
Secondary outcomes (1)
Correlations between morbidity, degree of adenoid hypertrophy and feeding position
Correlation between respiratory morbidity, ear morbidity, laboratory and chest \& nasopharynx X-rays with feeding position in first year of life
Correlation between respiratory and ENT morbidity with degree of adenoid obstruction, allergy, GER and infant feeding position during the first 2 years of life.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jan 2003
- Primary completion31 Dec 2018
- Study completion6 Jun 2020
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 Adenoid HypertrophyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services
- Responsible party
- Principal investigator, Avital Avraham, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431128
- Sponsor's protocol ID
- Clalit HS
- Status last verified
- Jun 2020
- First submitted
- 7 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Individual data sharing
- No
Publications
Tully SB, Bar-Haim Y, Bradley RL. Abnormal tympanography after supine bottle feeding. J Pediatr. 1995 Jun;126(6):S105-11. doi: 10.1016/s0022-3476(95)90249-x.
PubMed 7776069Konno A, Hoshino T, Togawa K. Influence of upper airway obstruction by enlarged tonsils and adenoids upon recurrent infection of the lower airway in childhood. Laryngoscope. 1980 Oct;90(10 Pt 1):1709-16.
PubMed 7421381Avital A, Donchin M, Springer C, Cohen S, Danino E. Feeding young infants with their head in upright position reduces respiratory and ear morbidity. Sci Rep. 2018 Apr 26;8(1):6588. doi: 10.1038/s41598-018-24636-0.
PubMed 29700412
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenoid Hypertrophy, Etiology, Clinical Manifestations and Related Morbidity, Correlation With Infant Feeding Position
- ClinicalTrials.gov ID
- NCT04431128
- Acronym / sponsor ID
- Clalit HS
- Conditions
- Adenoid Hypertrophy
- Keywords
- Adenoid hypertrophy, Allergy, Infant Feeding Position, GER, Pneumonia, Bronchitis, Otitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Clalit Health Services
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 6 Jun 2020 (actual)
- First posted
- 16 Jun 2020 (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.
500 children aged 0-5 years followed since birth by Principal Investigator (PI)since January1, 2003 till December 31, 2018 and diagnosed with adenoid hypertrophy (AH) (study group) and 500 children aged 0-5 years followed by principal investigator during the same years and diagnosed as urinary tract infection (UTI), gastroenteritis (GE), diarrhea, vomiting but without AH (control group) were compared. Morbidity and treatment will be compared and correlated with gastro-esophageal reflux (GER), allergy and infant feeding position during the first few years of life in the two groups.
Detailed description
The 2 groups are children aged 0-5 years and treated by PI and followed since birth during years 2003-2018. Study group consists of children diagnosed at least 2 times as AH and control group as similar children with UTI, GE, vomiting or diarrhea. Respiratory problems (pneumonia, bronchopneumonia, bronchitis), ear problems (otitis media OM, serous OM), antibiotic treatment, use of bronchodilators, inhaled corticosteroid (ICS), chest X-rays, anomalous laboratory results, emergency room visits and hospitalization rates will be compared in the two groups, together with details concerning feeding position during the first years of life. Correlation between morbidity, degree of nasopharyngeal obstruction, allergy, GER and supine feeding position, will be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Behavioral: infant feeding positionAdenoid hypertrophy |
| Control group | – | Behavioral: infant feeding positionUTI, GE, vomiting, diarrhea |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Young infants followed since birth or from the first half of the first year of life, followed at least for 5 years by PI, study group (till 500 children) with the diagnosis of AH, control group (till 500 children) diagnosed as UTI, GE, vomiting or diarrhea and without AH.
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 |
|---|---|---|
| infant feeding positioncorrelation with allergy, GER or feeding position | Behavioural | Control group, study group |
Primary outcome
Respiratory complications
Time frame: 3 years
Number of participants with Pneumonia, bronchitis
Ear complications
Time frame: 3 years
Number of participants with otitis media, serous otitis media
1 secondary outcome
Correlations between morbidity, degree of adenoid hypertrophy and feeding position
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Results publication: PubMed 7776069Tully SB, Bar-Haim Y, Bradley RL. Abnormal tympanography after supine bottle feeding. J Pediatr. 1995 Jun;126(6):S105-11. doi: 10.1016/s0022-3476(95)90249-x.
- Results publication: PubMed 7421381Konno A, Hoshino T, Togawa K. Influence of upper airway obstruction by enlarged tonsils and adenoids upon recurrent infection of the lower airway in childhood. Laryngoscope. 1980 Oct;90(10 Pt 1):1709-16.
- Results publication: PubMed 29700412Avital A, Donchin M, Springer C, Cohen S, Danino E. Feeding young infants with their head in upright position reduces respiratory and ear morbidity. Sci Rep. 2018 Apr 26;8(1):6588. doi: 10.1038/s41598-018-24636-0.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adenoid 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?
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: finished, as of the sponsor's last update on 16 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Respiratory complications (time frame: 3 years). 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?
On the ClinicalTrials.gov record for NCT04431128, 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 Jun 2020.