RuminationNCT01185327
Do Isreali Infants of Ethiopian Origin Mother Regurgitate More Than Other Infants?
An observational study of Rumination, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Nursing team of well baby nursery at Hillel Yaffe medical center in Hadera, Israel have noticed that infant of Ethiopian-origin mothers regurgitate more than other infants. Probably, these infants are breastfeed much more than other infants. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Rumination
- What is being tested?
- Breastfeeding
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 220 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Dec 2010
- Phase
- Observational
- 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 Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants born at Hillel Yaffe medical center during 2009
Who may be able to join
- Infants born at Hillel Yaffe medical center during 2009 (To Ethiopian origin mother in study group, and to non-Ethiopian origin mothers in control group)
Who cannot join
- Infants who were transferred to NICU for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Nursing team of well baby nursery at Hillel Yaffe medical center in Hadera, Israel have noticed that infant of Ethiopian-origin mothers regurgitate more than other infants. Probably, these infants are breastfeed much more than other infants.
Some Ethiopian-origin mothers are used to eat teff-flower porridge during the last weeks of pregnancy and after birth, in order to expand milk production.
Study goal is to find out if infants of Ethiopian-origin mother do regurgitate more than others, and if they weight gain is similar to other infants. Another goal is to find out if breastfeeding mothers of Ethiopian origin do eat that porridge, and if there is any difference between those who do eat that porridge and those who do not.
Read the detailed description
Nursing team of well baby nursery at Hillel Yaffe medical center in Hadera, Israel have noticed that infant of Ethiopian-origin mothers regurgitate more than other infants. Probably, these infants are breastfeed much more than other infants.
Some Ethiopian-origin mothers are used to eat teff-flower porridge during the last weeks of pregnancy and after birth, in order to expand milk production.
Study goal is to find out if infants of Ethiopian-origin mother do regurgitate more than others, and if they weight gain is similar to other infants. Another goal is to find out if breastfeeding mothers of Ethiopian origin do eat that porridge, and if there is any difference between those who do eat that porridge and those who do not.
- Conditions
- Rumination
- Being tested
- Breastfeeding
- Keywords
- Regurgitation, Infants to Israeli Ethiopian-origin mothers
- Medical subject headings
- Rumination Syndrome, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastfeedingBehavioural
Breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| Study | Infants to Israeli Ethiopian-origin Mothers Receives: Behavioral: Breastfeeding | |
| Control | Infants to Israeli non-Ethiopian-origin mothers Receives: Behavioral: Breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
% weight decrease
Proportion of minimal weight during hospitalization to birth weight
Measured: First week of life
Secondary outcomes (1)
Number of regurgitations per day
Measured: First week of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for RuminationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Investigators
- Erez Nadir, MD, Principal investigator, Hillel Yaffe medical center, Hadera, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185327
- Sponsor's protocol ID
- 0066-10-HYMC-CTIL
- Status last verified
- Jun 2011
- First submitted
- 17 Aug 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Barak M, Lahav S, Mimouni FB, Dollberg S. The prevalence of regurgitations in the first 2 days of life in human milk- and formula-fed term infants. Breastfeed Med. 2006 Autumn;1(3):168-71. doi: 10.1089/bfm.2006.1.168.
PubMed 17661594Hegar B, Dewanti NR, Kadim M, Alatas S, Firmansyah A, Vandenplas Y. Natural evolution of regurgitation in healthy infants. Acta Paediatr. 2009 Jul;98(7):1189-93. doi: 10.1111/j.1651-2227.2009.01306.x. Epub 2009 Apr 21.
PubMed 19397533Asefa M, Hewison J, Drewett R. Traditional nutritional and surgical practices and their effects on the growth of infants in south-west Ethiopia. Paediatr Perinat Epidemiol. 1998 Apr;12(2):182-98. doi: 10.1046/j.1365-3016.1998.00104.x.
PubMed 9620568Wenlock RJ, Wenlock RW. Maternal nutrition, prolonged lactation and birth spacing in Ethiopia. J Biosoc Sci. 1981 Jul;13(3):261-8. doi: 10.1017/s0021932000013456.
PubMed 7276029Getahun Z, Scherbaum V, Taffese Y, Teshome B, Biesalski HK. Breastfeeding in Tigray and Gonder, Ethiopia, with special reference to exclusive/almost exclusive breastfeeding beyond six months. Breastfeed Rev. 2004 Nov;12(3):8-16.
PubMed 17891858Meftuh AB, Tapsoba LP, Lamounier JA. Breastfeeding practices in Ethiopian women in southern California. Indian J Pediatr. 1991 May-Jun;58(3):349-56. doi: 10.1007/BF02754966.
PubMed 1937647Zeisel SH. Is maternal diet supplementation beneficial? Optimal development of infant depends on mother's diet. Am J Clin Nutr. 2009 Feb;89(2):685S-7S. doi: 10.3945/ajcn.2008.26811F. Epub 2008 Dec 30.
PubMed 19116319
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Isreali Infants of Ethiopian Origin Mother Regurgitate More Than Other Infants?
- ClinicalTrials.gov ID
- NCT01185327
- Acronym / sponsor ID
- 0066-10-HYMC-CTIL
- Conditions
- Rumination
- Keywords
- Regurgitation, Infants to Israeli Ethiopian-origin mothers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Aug 2010 (estimated)
- 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.
Nursing team of well baby nursery at Hillel Yaffe medical center in Hadera, Israel have noticed that infant of Ethiopian-origin mothers regurgitate more than other infants. Probably, these infants are breastfeed much more than other infants.
Some Ethiopian-origin mothers are used to eat teff-flower porridge during the last weeks of pregnancy and after birth, in order to expand milk production.
Study goal is to find out if infants of Ethiopian-origin mother do regurgitate more than others, and if they weight gain is similar to other infants. Another goal is to find out if breastfeeding mothers of Ethiopian origin do eat that porridge, and if there is any difference between those who do eat that porridge and those who do not.
Detailed description
Nursing team of well baby nursery at Hillel Yaffe medical center in Hadera, Israel have noticed that infant of Ethiopian-origin mothers regurgitate more than other infants. Probably, these infants are breastfeed much more than other infants.
Some Ethiopian-origin mothers are used to eat teff-flower porridge during the last weeks of pregnancy and after birth, in order to expand milk production.
Study goal is to find out if infants of Ethiopian-origin mother do regurgitate more than others, and if they weight gain is similar to other infants. Another goal is to find out if breastfeeding mothers of Ethiopian origin do eat that porridge, and if there is any difference between those who do eat that porridge and those who do not.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | Behavioral: BreastfeedingInfants to Israeli Ethiopian-origin Mothers |
| Control | – | Behavioral: BreastfeedingInfants to Israeli non-Ethiopian-origin mothers |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants born at Hillel Yaffe medical center during 2009
Key inclusion criteria (1 listed)
- Infants born at Hillel Yaffe medical center during 2009 (To Ethiopian origin mother in study group, and to non-Ethiopian origin mothers in control group)
Key exclusion criteria (1 listed)
- Infants who were transferred to NICU for any reason.
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 |
|---|---|---|
| BreastfeedingBreastfeeding | Behavioural | Control, Study |
Primary outcome
% weight decrease
Time frame: First week of life
Proportion of minimal weight during hospitalization to birth weight
1 secondary outcome
Number of regurgitations per day
Time frame: First week of life
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 8 Jun 2011.
- Background: PubMed 17661594Barak M, Lahav S, Mimouni FB, Dollberg S. The prevalence of regurgitations in the first 2 days of life in human milk- and formula-fed term infants. Breastfeed Med. 2006 Autumn;1(3):168-71. doi: 10.1089/bfm.2006.1.168.
- Background: PubMed 19397533Hegar B, Dewanti NR, Kadim M, Alatas S, Firmansyah A, Vandenplas Y. Natural evolution of regurgitation in healthy infants. Acta Paediatr. 2009 Jul;98(7):1189-93. doi: 10.1111/j.1651-2227.2009.01306.x. Epub 2009 Apr 21.
- Background: PubMed 9620568Asefa M, Hewison J, Drewett R. Traditional nutritional and surgical practices and their effects on the growth of infants in south-west Ethiopia. Paediatr Perinat Epidemiol. 1998 Apr;12(2):182-98. doi: 10.1046/j.1365-3016.1998.00104.x.
- Background: PubMed 7276029Wenlock RJ, Wenlock RW. Maternal nutrition, prolonged lactation and birth spacing in Ethiopia. J Biosoc Sci. 1981 Jul;13(3):261-8. doi: 10.1017/s0021932000013456.
- Background: PubMed 17891858Getahun Z, Scherbaum V, Taffese Y, Teshome B, Biesalski HK. Breastfeeding in Tigray and Gonder, Ethiopia, with special reference to exclusive/almost exclusive breastfeeding beyond six months. Breastfeed Rev. 2004 Nov;12(3):8-16.
- Background: PubMed 1937647Meftuh AB, Tapsoba LP, Lamounier JA. Breastfeeding practices in Ethiopian women in southern California. Indian J Pediatr. 1991 May-Jun;58(3):349-56. doi: 10.1007/BF02754966.
- Background: PubMed 19116319Zeisel SH. Is maternal diet supplementation beneficial? Optimal development of infant depends on mother's diet. Am J Clin Nutr. 2009 Feb;89(2):685S-7S. doi: 10.3945/ajcn.2008.26811F. Epub 2008 Dec 30.
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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.
Erez Nadir, MD principal investigator
Hillel Yaffe medical center, Hadera, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rumination, run by Hillel Yaffe Medical Center 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 8 Jun 2011. 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?
% weight decrease (time frame: First week of life). 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 NCT01185327, which also lists 7 linked publications.
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 8 Jun 2011.