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The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity

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ClinicalTrials.gov Identifier: NCT03247946
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Avital Avraham, Hadassah Medical Organization

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

Condition or disease Intervention/treatment Phase
Feeding and Eating Disorders Behavioral: upright head position Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity
Actual Study Start Date : September 13, 2010
Actual Primary Completion Date : August 19, 2012
Actual Study Completion Date : August 19, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Active Comparator: Intervention group
intervention: upright head position
Behavioral: upright head position
Bottle feeding of infants with their head in upward and not supine head position

No Intervention: Control group
no feeding position instructions



Primary Outcome Measures :
  1. Infant morbidity [ Time Frame: 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 :
  1. Feeding position angle [ Time Frame: at beginning and end of study (1 year follow up) ]
    description of feeding position angle



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Ages Eligible for Study:   3 Months to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247946


Locations
Israel
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel, P.P.Box 12000
Sponsors and Collaborators
Hadassah Medical Organization

Publications of Results:
Responsible Party: Avital Avraham, Principal investigator, Associate Professor, Institute of Pulmonology, email: avital@hadassah.org.il, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT03247946     History of Changes
Other Study ID Numbers: 0349-10-HMO
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Avital Avraham, Hadassah Medical Organization:
infant
feeding position
respiratory
ear

Additional relevant MeSH terms:
Feeding and Eating Disorders
Mental Disorders