The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity

Feeding and Eating Disorders Clinical Trial

Official title:

The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247946
• Other study ID #: 0349-10-HMO
• Status: Completed
• Phase: N/A
• First received: August 3, 2017
• Last updated: August 12, 2017
• Start date: September 13, 2010
• Est. completion date: August 19, 2012

Study information

• Verified date: August 2017
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: August 19, 2012
• Est. primary completion date: August 19, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Feeding and Eating Disorders

Intervention

Behavioral:
• upright head position
Bottle feeding of infants with their head in upward and not supine head position

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Tully SB, Bar-Haim Y, Bradley RL. Abnormal tympanography after supine bottle feeding. J Pediatr. 1995 Jun;126(6):S105-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant morbidity	respiratory (cough, wheezing, physician diagnosed bronchitis or pneumonia), ear (OM, SOM), prolonged fever, use of antibiotics and inhalations.	every 12 weeks visit to Mother Child Health clinic until end of 1 year follow up
Secondary	Feeding position angle	description of feeding position angle	at beginning and end of study (1 year follow up)