NCT01185327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

4 months

First QC Date

August 17, 2010

Last Update Submit

June 5, 2011

Conditions

Rumination

Keywords

RegurgitationInfants to Israeli Ethiopian-origin mothers

Outcome Measures

Primary Outcomes (1)

  • % weight decrease

    Proportion of minimal weight during hospitalization to birth weight

    First week of life

Secondary Outcomes (1)

  • Number of regurgitations per day

    First week of life

Study Arms (2)

Study

Infants to Israeli Ethiopian-origin Mothers

Behavioral: Breastfeeding

Control

Infants to Israeli non-Ethiopian-origin mothers

Behavioral: Breastfeeding

Interventions

BreastfeedingBEHAVIORAL

Breastfeeding

ControlStudy

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants born at Hillel Yaffe medical center during 2009

You may qualify if:

  • 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)

You may not qualify if:

  • Infants who were transferred to NICU for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe medical center

Hadera, 38100, Israel

Location

Related Publications (7)

  • 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.

    PMID: 17661594BACKGROUND

  • Hegar 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.

    PMID: 19397533BACKGROUND

  • Asefa 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.

    PMID: 9620568BACKGROUND

  • Wenlock 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.

    PMID: 7276029BACKGROUND

  • Getahun 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.

    PMID: 17891858BACKGROUND

  • Meftuh 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.

    PMID: 1937647BACKGROUND

  • Zeisel 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.

    PMID: 19116319BACKGROUND

MeSH Terms

Conditions

Rumination SyndromeGastroesophageal Reflux

Interventions

Lactation

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental DisordersEsophageal Motility DisordersDeglutition DisordersEsophageal Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Officials

  • Erez Nadir, MD

    Hillel Yaffe medical center, Hadera, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 19, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

IL(1)