Adenoid Hypertrophy, Respiratory Complications and Correlation With Infant Feeding Position

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.

Study Overview

• Status: Completed
• Conditions: Adenoid Hypertrophy
• Intervention / Treatment: Behavioral: infant feeding position

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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, P.P.Box 12000
    • Hadassah Medical Organization, Jerusalem, Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study group; Adenoid hypertrophy	Behavioral: infant feeding position; correlation with allergy, GER or feeding position
Control group; UTI, GE, vomiting, diarrhea	Behavioral: infant feeding position; correlation with allergy, GER or feeding position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory complications	Number of participants with Pneumonia, bronchitis	3 years
Ear complications	Number of participants with otitis media, serous otitis media	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Collaborators: Clalit Health Services

Publications and helpful links

General 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.
• Konno 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.
• Avital 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2003
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): June 6, 2020

Study Registration Dates

• First Submitted: June 7, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Pneumonia; Allergy; Bronchitis; GER; Otitis; Adenoid hypertrophy; Infant Feeding Position
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: Clalit HS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No