Adenoid Hypertrophy, Respiratory Complications and Correlation With Infant Feeding Position

Completed

• Conditions: Adenoid Hypertrophy
• Interventions: Behavioral: infant feeding position

• Registration Number: NCT04431128
• Lead Sponsor: Hadassah Medical Organization

Brief 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), 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 Timeline

• Study Start: 2003-01-01
• Primary Completion: 2018-12-31
• Status Verified: 2020-06
• Study Completion: 2020-06-06
• Study First Submitted: 2020-06-07
• Study First Submitted QC: 2020-06-11
• Last Update Submitted: 2020-06-11
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	infant feeding position	Adenoid hypertrophy
Control group	infant feeding position	UTI, GE, vomiting, diarrhea

Primary Outcome Measures

Name	Time	Method
Ear complications	3 years	Number of participants with otitis media, serous otitis media
Respiratory complications	3 years	Number of participants with Pneumonia, bronchitis

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hadassah Medical Organization, Jerusalem, Israel; 🇮🇱 Jerusalem, Israel