The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity

NCT ID: NCT03247946

Last Updated: 2017-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-13

Study Completion Date

2012-08-19

Brief Summary

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

Detailed Description

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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.

Conditions

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Feeding and Eating Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

intervention: upright head position

Group Type ACTIVE_COMPARATOR

upright head position

Intervention Type BEHAVIORAL

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

Control group

no feeding position instructions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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upright head position

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Avital Avraham

Principal investigator, Associate Professor, Institute of Pulmonology, email: [email protected]

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type RESULT
PMID: 7776069 (View on PubMed)

Other Identifiers

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0349-10-HMO

Identifier Type: -

Identifier Source: org_study_id

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