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

Rumination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185327
• Other study ID #: 0066-10-HYMC-CTIL
• Status: Completed
• Phase: N/A
• First received: August 17, 2010
• Last updated: June 5, 2011
• Start date: August 2010
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Rumination

Intervention

Behavioral:
• Breastfeeding
Breastfeeding

Locations

Country	Name	City	State
Israel	Hillel Yaffe medical center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Meftuh AB, Tapsoba LP, Lamounier JA. Breastfeeding practices in Ethiopian women in southern California. Indian J Pediatr. 1991 May-Jun;58(3):349-56. — View Citation

Wenlock RJ, Wenlock RW. Maternal nutrition, prolonged lactation and birth spacing in Ethiopia. J Biosoc Sci. 1981 Jul;13(3):261-8. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% weight decrease	Proportion of minimal weight during hospitalization to birth weight	First week of life	No
Secondary	Number of regurgitations per day		First week of life	No