Back to resultsThe Influence of Upright Feeding Position on Pulmonary and Ear Morbidity
Primary Purpose
Feeding and Eating Disorders
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
upright head position
Sponsored by
About this trial
This is an interventional prevention trial for Feeding and Eating Disorders focused on measuring infant, feeding position, respiratory, ear
Eligibility Criteria
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
Sites / Locations
- Hadassah Medical Organization, Jerusalem, Israel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention group
Control group
Arm Description
intervention: upright head position
no feeding position instructions
Outcomes
Primary Outcome Measures
Infant morbidity
respiratory (cough, wheezing, physician diagnosed bronchitis or pneumonia), ear (OM, SOM), prolonged fever, use of antibiotics and inhalations.
Secondary Outcome Measures
Feeding position angle
description of feeding position angle
Full Information
NCT ID
NCT03247946
First Posted
August 3, 2017
Last Updated
August 12, 2017
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT03247946
Brief Title
The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity
Official Title
The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 13, 2010 (Actual)
Primary Completion Date
August 19, 2012 (Actual)
Study Completion Date
August 19, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding and Eating Disorders
Keywords
infant, feeding position, respiratory, ear
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
intervention: upright head position
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no feeding position instructions
Intervention Type
Behavioral
Intervention Name(s)
upright head position
Intervention Description
Bottle feeding of infants with their head in upward and not supine head position
Primary Outcome Measure Information:
Title
Infant morbidity
Description
respiratory (cough, wheezing, physician diagnosed bronchitis or pneumonia), ear (OM, SOM), prolonged fever, use of antibiotics and inhalations.
Time Frame
every 12 weeks visit to Mother Child Health clinic until end of 1 year follow up
Secondary Outcome Measure Information:
Title
Feeding position angle
Description
description of feeding position angle
Time Frame
at beginning and end of study (1 year follow up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hadassah Medical Organization, Jerusalem, Israel
City
Jerusalem
ZIP/Postal Code
P.P.Box 12000
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
7776069
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.
Results Reference
result
Learn more about this trial
The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity
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