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Completed

NCT Number: NCT03247946

The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity

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

Completed

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Key information

Age range

3 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, P.P.Box 12000, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

upright head position

Behavioral

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

Primary outcomes

  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 outcomes

  1. Feeding position angle

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

    description of feeding position angle

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 14, 2017
Registry last updated
Aug 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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