CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
Intervention education +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03181269
NCT03181269N/ACompleted

Human Milk and Infant Intestinal Microbiome Study

University of Virginia·interventional·Posted Jun 8, 2017·Updated Dec 21, 2018

In Brief

A clinical study evaluating Intervention education and Placebo Education for Breast Feeding and Human Microbiome. Completed, enrolled 6 participants across 1 site.

Detailed Summary

This study will explore the effects of skin-to-skin contact (SSC) between mothers and their babies on the infant intestinal microbiome, the maternal skin microbiome and the breast milk microbiome. This will be accomplished by administering an intervention education session to one group and a placebo education session to the second group in order to influence the magnitude of total SSC defined by the frequency and duration of contact time between the two groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 8, 2017
Enrollment StartJul 27, 2017
Primary CompletionDec 20, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.1 years ago

Interventions

Intervention educationother

An education package that includes an enhanced emphasis on maternal-infant skin-to-skin contact and a detailed activity log for recording early post-partum care practices that includes specific skin-to-skin contact time and frequency goals.

Placebo Educationother

An education package that includes a basic emphasis on maternal-infant skin-to-skin contact, as well as other general post-partum care practices and a general early post-partum care practices log without specific skin-to-skin contact goals.