Adenoid Hypertrophy, Respiratory Complications and Correlation With Infant Feeding Position
Status:
Completed
Sponsors
Hadassah Medical Organization
Collaborators
Clalit Health Services
Abstract:
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.
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.
Last Verified:May/31/2020
First Submitted:June/6/2020
Estimated Enrollment Submitted:June/10/2020
First Posted:June/15/2020
Last Update Submitted:June/10/2020
Last Update Posted:June/15/2020
Actual Study Start Date:December/31/2002
Estimated Primary Completion Date:December/30/2018
Estimated Study Completion Date:June/5/2020
Condition or disease:Adenoid Hypertrophy
Intervention/treatment:
Behavioral:
Phase:-
Study design:
Study Type:Observational
Observational Model:Case-Control
Time Perspective:Retrospective
Arm group:
ArmIntervention/treatment
study group
Adenoid hypertrophy
Control group
UTI, GE, vomiting, diarrhea
Eligibility Criteria:
Ages Eligible for Study:1 Month to 1 Month
Sexes Eligible for Study:All
Sampling method:Probability Sample
Accepts Healthy Volunteers:Yes
Criteria:

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.

Outcome:
Primary Outcome Measures
1. Respiratory complications [3 years]
Number of participants with Pneumonia, bronchitis
2. Ear complications [3 years]
Number of participants with otitis media, serous otitis media
Secondary Outcome Measures
1. Correlations between morbidity, degree of adenoid hypertrophy and feeding position [5 years]
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.
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Clinical Trial
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