The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity

NCT03247946 | Completed

• 1 other identifier: 0349-10-HMO
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Feeding and Eating Disorders

Keywords

infant; feeding position; respiratory; ear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Feeding position angle

  at beginning and end of study (1 year follow up)

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

intervention: upright head position

Behavioral: upright head position

Control group

NO INTERVENTION

no feeding position instructions

Interventions

upright head position BEHAVIORAL

Bottle feeding of infants with their head in upward and not supine head position

Intervention group

Eligibility Criteria

• Age: 3 Months - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, P.P.Box 12000, Israel

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Associate Professor, Institute of Pulmonology, email: avital@hadassah.org.il

Model Details: 3 month old infants were recruited from 2 Mother-Child-Health clinics and followed for 12 months. Mothers from intervention group were instructed to feed their babies (88 infants) with their head in upright position. Mothers from control group (75 infants) fed their infant regularly without any instructions . Respiratory and ear morbidity were evaluated during the following 12 month period.

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 14, 2017
• Study Start: September 13, 2010
• Primary Completion: August 19, 2012
• Study Completion: August 19, 2012
• Last Updated: August 16, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)