The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity

Not Applicable

Completed

• Conditions: Feeding and Eating Disorders
• Interventions: Behavioral: upright head position

• Registration Number: NCT03247946
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Does upright feeding position of 3 month old infants reduce respiratory and ear morbidity during the following year?

Detailed Description

The investigators examined the influence of teaching mothers to feed infants with their head in an upright position and evaluated the infant ear and respiratory morbidity during a one-year follow-up. Mothers of 88 infants born during 2011 were instructed by trained nurses at Maternal-Child-Health clinics to feed their infants with their head in upright position (intervention group). The control group consisted of 75 mothers of infants of similar socioeconomic background who fed their infant regularly without any instructions and were followed at another Maternal-Child-Health clinic. Feeding position was evaluated at the beginning and the end of the study, and morbidity data of both groups were evaluated at every 3-month follow-up meeting. The study was part of the PhD thesis of Efrat Danino, Head Nurse of Pediatric Department at Hadassah Medical Organization.

Study Timeline

• Study Start: 2010-09-13
• Primary Completion: 2012-08-19
• Study Completion: 2012-08-19
• Status Verified: 2017-08
• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-09
• Last Update Submitted: 2017-08-12
• Study First Posted: 2017-08-14
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

• healthy 3 month old infants, bottle fed at least once a day, parent agreeing to participate

Exclusion Criteria

• Prematurity, need of supplemental oxygen, broncho-pulmonary dysplasia, cystic fibrosis, familial dysautonomia, cleft lip or cleft palate, any ear-throat-lung or airway congenital anomaly, congenital heart disease, any other chronic disease of childhood or malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	upright head position	intervention: upright head position

Primary Outcome Measures

Name	Time	Method
Infant morbidity	every 12 weeks visit to Mother Child Health clinic until end of 1 year follow up	respiratory (cough, wheezing, physician diagnosed bronchitis or pneumonia), ear (OM, SOM), prolonged fever, use of antibiotics and inhalations.

Secondary Outcome Measures

Name	Time	Method
Feeding position angle	at beginning and end of study (1 year follow up)	description of feeding position angle

Trial Locations

Locations (1)

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