Adenoid Hypertrophy, Respiratory Complications and Correlation With Infant Feeding Position

NCT04431128 | Completed

• 1 other identifier: Clalit HS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenoid Hypertrophy

Keywords

Adenoid hypertrophy; Allergy; Infant Feeding Position; GER; Pneumonia; Bronchitis; Otitis

Outcome Measures

Primary Outcomes (2)

• Respiratory complications

  Number of participants with Pneumonia, bronchitis

  3 years

• Ear complications

  Number of participants with otitis media, serous otitis media

  3 years

Secondary Outcomes (1)

• Correlations between morbidity, degree of adenoid hypertrophy and feeding position

  5 years

Study Arms (2)

study group

Adenoid hypertrophy

Behavioral: infant feeding position

Control group

UTI, GE, vomiting, diarrhea

Behavioral: infant feeding position

Interventions

infant feeding position BEHAVIORAL

correlation with allergy, GER or feeding position

Control group; study group

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may not qualify if:

• Children older than 6 months of age when starting to be followed by PI.

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Clalit Health Services: collaborator

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, P.P.Box 12000, Israel

Location

Related Publications (3)

• 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.

  PMID: 7776069 RESULT

• 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.

  PMID: 7421381 RESULT

• 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.

  PMID: 29700412 RESULT

MeSH Terms

Conditions

Hypersensitivity; Pneumonia; Bronchitis; Otitis

Condition Hierarchy (Ancestors)

Immune System Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: June 16, 2020
• Study Start: January 1, 2003
• Primary Completion: December 31, 2018
• Study Completion: June 6, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)