Do Isreali Infants of Ethiopian Origin Mother Regurgitate... | NCT01185327

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

NCT01185327

Sponsor

Hillel Yaffe Medical Center

Status

Completed

Last Update Posted

Jun 8, 2011Estimated

Enrollment

220Actual

Phase

Not provided

Conditions

Rumination

Interventions

Breastfeeding

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Aug 17, 2010

First Submission Date that Met QC Criteria

Aug 18, 2010

First Posted Date

Aug 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2011

Last Update Posted Date

Jun 8, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hillel Yaffe Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study		Infants to Israeli Ethiopian-origin Mothers	Behavioral: Breastfeeding
Control		Infants to Israeli non-Ethiopian-origin mothers	Behavioral: Breastfeeding

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breastfeeding	Behavioral	Breastfeeding	Control Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
% weight decrease	Proportion of minimal weight during hospitalization to birth weight	First week of life

Secondary Outcomes

Measure	Description	Time Frame
Number of regurgitations per day		First week of life

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Days

Standard Ages

Child

Study Population

Infants born at Hillel Yaffe medical center during 2009

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erez Nadir, MD	Hillel Yaffe medical center, Hadera, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe medical center		Hadera		38100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17661594	Background	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.
19397533	Background	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.

ID	Term
D000079562	Rumination Syndrome
D005764	Gastroesophageal Reflux

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D001068	Feeding and Eating Disorders
D001523	Mental Disorders

ID	Term
D055703	Reproductive Physiological Phenomena
D012101	Reproductive and Urinary Physiological Phenomena
D049590	Postpartum Period