ClinicalTrials.gov
ClinicalTrials.gov Menu

Do Isreali Infants of Ethiopian Origin Mother Regurgitate More Than Other Infants?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01185327
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Hillel Yaffe Medical Center

Brief 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.

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.


Condition or disease Intervention/treatment
Rumination Behavioral: Breastfeeding

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 Type : Observational
Actual Enrollment : 220 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Do Isreali Infants of Ethiopian Origin Mother Regurgitate More Than Other Infants?
Study Start Date : August 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Group/Cohort Intervention/treatment
Study
Infants to Israeli Ethiopian-origin Mothers
Behavioral: Breastfeeding
Breastfeeding
Control
Infants to Israeli non-Ethiopian-origin mothers
Behavioral: Breastfeeding
Breastfeeding



Primary Outcome Measures :
  1. % weight decrease [ Time Frame: First week of life ]
    Proportion of minimal weight during hospitalization to birth weight


Secondary Outcome Measures :
  1. Number of regurgitations per day [ Time Frame: First week of life ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infants born at Hillel Yaffe medical center during 2009
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Infants who were transferred to NICU for any reason.

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): NCT01185327


Locations
Israel
Hillel Yaffe medical center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Erez Nadir, MD Hillel Yaffe medical center, Hadera, Israel

Publications:
Responsible Party: Erez Nadir, MD, Hillel Yaffe medical center
ClinicalTrials.gov Identifier: NCT01185327     History of Changes
Other Study ID Numbers: 0066-10-HYMC-CTIL
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by Hillel Yaffe Medical Center:
Regurgitation
Infants to Israeli Ethiopian-origin mothers