Clinical trial NCT04431128: Adenoid Hypertrophy, Respiratory Complications and Correlation With Infant Feeding Position
Official title: Adenoid Hypertrophy, Etiology, Clinical Manifestations and Related Morbidity, Correlation With Infant Feeding Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenoid Hypertrophy
Keywords: Adenoid hypertrophy
Allergy
Infant Feeding Position
GER
Pneumonia
Bronchitis
Otitis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
First posted: 2020-06-16
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Respiratory complications
timeFrame: 3 years
measure: Ear complications
timeFrame: 3 years
Secondary outcomes:
measure: Correlations between morbidity, degree of adenoid hypertrophy and feeding position
timeFrame: 5 years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.