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Completed

NCT Number: NCT04431128

Adenoid Hypertrophy, Respiratory Complications and 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.

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Key information

Conditions

Adenoid Hypertrophy Bronchial Diseases Bronchitis Ear Diseases Hypersensitivity Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Otitis Otorhinolaryngologic Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, P.P.Box 12000, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

infant feeding position

Behavioral

correlation with allergy, GER or feeding position

Primary outcomes

  1. Respiratory complications

    Time frame: 3 years

    Number of participants with Pneumonia, bronchitis

  2. Ear complications

    Time frame: 3 years

    Number of participants with otitis media, serous otitis media

Secondary outcomes

  1. Correlations between morbidity, degree of adenoid hypertrophy and feeding position

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • Clalit Health Services

Registry information

Official study title

Adenoid Hypertrophy, Etiology, Clinical Manifestations and Related Morbidity, Correlation With Infant Feeding Position

Important dates

Study start
2003
Primary completion
2018
Study completion
2020
First posted
Jun 16, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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