Clinical trial NCT01185327: Do Isreali Infants of Ethiopian Origin Mother Regurgitate More Than Other Infants?
Official title: Do Isreali Infants of Ethiopian Origin Mother Regurgitate More Than Other Infants?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rumination
Keywords: Regurgitation
Infants to Israeli Ethiopian-origin mothers
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-08-19
Enrollment: 220
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born at Hillel Yaffe medical center during 2009

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.

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.

Eligibility 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.

Primary outcomes:
measure: % weight decrease
timeFrame: First week of life
Secondary outcomes:
measure: Number of regurgitations per day
timeFrame: First week of life
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe medical center
Study officials:
affiliation: Hillel Yaffe medical center, Hadera, Israel
name: Erez Nadir, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1089/bfm.2006.1.168.
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.
citation: 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.
citation: 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.
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.
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. doi: 10.1007/BF02754966.
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.