Feeding and Eating DisordersNCT03247946
The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity
A study testing upright head position in people with Feeding and Eating Disorders, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Does upright feeding position of 3 month old infants reduce respiratory and ear morbidity during the following year? Read more about this study
- Who is it for?
- Ages 3 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Feeding and Eating Disorders
- What is being tested?
- upright head position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Sep 2010to 19 Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy 3 month old infants, bottle fed at least once a day, parent agreeing to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, P.P.Box 12000
About this study
Does upright feeding position of 3 month old infants reduce respiratory and ear morbidity during the following year?
Read the 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.
- Conditions
- Feeding and Eating Disorders
- Being tested
- upright head position
- Keywords
- infant, feeding position, respiratory, ear
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upright head positionBehavioural
Bottle feeding of infants with their head in upward and not supine head position
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | intervention: upright head position Receives: Behavioral: upright head position |
| Control group | No intervention | no feeding position instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant morbidity
respiratory (cough, wheezing, physician diagnosed bronchitis or pneumonia), ear (OM, SOM), prolonged fever, use of antibiotics and inhalations.
Measured: every 12 weeks visit to Mother Child Health clinic until end of 1 year follow up
Secondary outcomes (1)
Feeding position angle
description of feeding position angle
Measured: at beginning and end of study (1 year follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start13 Sep 2010
- Primary completion19 Aug 2012
- Study completion19 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding and Eating DisordersStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avital Avraham, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247946
- Sponsor's protocol ID
- 0349-10-HMO
- Status last verified
- Aug 2017
- First submitted
- 3 Aug 2017
- Last updated
- 16 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7776069
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity
- ClinicalTrials.gov ID
- NCT03247946
- Acronym / sponsor ID
- 0349-10-HMO
- Conditions
- Feeding and Eating Disorders
- Keywords
- infant, feeding position, respiratory, ear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 13 Sep 2010 (actual)
- Primary completion
- 19 Aug 2012 (actual)
- Study completion
- 19 Aug 2012 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: upright head positionintervention: upright head position |
| Control group | No intervention | –no feeding position instructions |
Who may qualify
- Ages
- 3 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy 3 month old infants, bottle fed at least once a day, parent agreeing to participate
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| upright head positionBottle feeding of infants with their head in upward and not supine head position | Behavioural | Intervention group |
Primary outcome
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.
1 secondary outcome
Feeding position angle
Time frame: at beginning and end of study (1 year follow up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Results publication: PubMed 7776069Tully 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upright head position in people with Feeding and Eating Disorders, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant morbidity (time frame: every 12 weeks visit to Mother Child Health clinic until end of 1 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03247946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2017.