NCT03181269

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

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

First Submitted

Initial submission to the registry

June 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 27, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

1.4 years

First QC Date

June 6, 2017

Last Update Submit

December 20, 2018

Conditions

Breast FeedingHuman Microbiome

Outcome Measures

Primary Outcomes (1)

  • Skin-to-skin contact

    Self-reported magnitude of maternal-infant skin-to-skin contact

    Duration of hospital admission after delivery (2-3 days)

Secondary Outcomes (4)

  • Maternal skin microbiome

    Duration of hospital admission after delivery (2-3 days)

  • Maternal breast milk microbiome

    Duration of hospital admission after delivery (2-3 days)

  • Infant intestinal microbiome

    Duration of hospital admission after delivery (2-3 days)

  • Maternal dietary intake

    During pregnancy

Study Arms (2)

Intervention education

EXPERIMENTAL

Participants will receive the intervention education and data recording package.

Other: Intervention education

Placebo education

PLACEBO COMPARATOR

Participants will receive the placebo educational and data recording package.

Other: Placebo Education

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.

Intervention education
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.

Placebo education

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women scheduled to deliver at the University of Virginia Health System
  • Women 18 years or older and their newborn infant
  • Stated intent to exclusively breastfeed for the duration of post-partum hospital admission
  • To have physical custody of their child when they are discharged from the hospital

You may not qualify if:

  • Maternal antibiotic use in the 3 months prior to delivery
  • Consumption of alcohol in the 3 months prior to delivery
  • Recreational drug use in the 3 months prior to delivery
  • Serious gastrointestinal conditions requiring medical intervention or medication during pregnancy (e.g. Crohn's disease, ulcerative colitis, celiac disease, gastrointestinal infections)
  • Serious health conditions that require medication during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (11)

  • Pannaraj PS, Li F, Cerini C, Bender JM, Yang S, Rollie A, Adisetiyo H, Zabih S, Lincez PJ, Bittinger K, Bailey A, Bushman FD, Sleasman JW, Aldrovandi GM. Association Between Breast Milk Bacterial Communities and Establishment and Development of the Infant Gut Microbiome. JAMA Pediatr. 2017 Jul 1;171(7):647-654. doi: 10.1001/jamapediatrics.2017.0378.

    PMID: 28492938BACKGROUND

  • Murphy K, Curley D, O'Callaghan TF, O'Shea CA, Dempsey EM, O'Toole PW, Ross RP, Ryan CA, Stanton C. The Composition of Human Milk and Infant Faecal Microbiota Over the First Three Months of Life: A Pilot Study. Sci Rep. 2017 Jan 17;7:40597. doi: 10.1038/srep40597.

    PMID: 28094284BACKGROUND

  • Posthuma S, Korteweg FJ, van der Ploeg JM, de Boer HD, Buiter HD, van der Ham DP. Risks and benefits of the skin-to-skin cesarean section - a retrospective cohort study. J Matern Fetal Neonatal Med. 2017 Jan;30(2):159-163. doi: 10.3109/14767058.2016.1163683. Epub 2016 Mar 29.

    PMID: 26955857BACKGROUND

  • Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.

    PMID: 27885658BACKGROUND

  • Rutten N, Van der Gugten A, Uiterwaal C, Vlieger A, Rijkers G, Van der Ent K. Maternal use of probiotics during pregnancy and effects on their offspring's health in an unselected population. Eur J Pediatr. 2016 Feb;175(2):229-35. doi: 10.1007/s00431-015-2618-1. Epub 2015 Aug 30.

    PMID: 26319129BACKGROUND

  • Jost T, Lacroix C, Braegger CP, Rochat F, Chassard C. Vertical mother-neonate transfer of maternal gut bacteria via breastfeeding. Environ Microbiol. 2014 Sep;16(9):2891-904. doi: 10.1111/1462-2920.12238. Epub 2013 Sep 3.

    PMID: 24033881BACKGROUND

  • Schloss PD, Iverson KD, Petrosino JF, Schloss SJ. The dynamics of a family's gut microbiota reveal variations on a theme. Microbiome. 2014 Jul 21;2:25. doi: 10.1186/2049-2618-2-25. eCollection 2014.

    PMID: 25061514BACKGROUND

  • Neu J, Rushing J. Cesarean versus vaginal delivery: long-term infant outcomes and the hygiene hypothesis. Clin Perinatol. 2011 Jun;38(2):321-31. doi: 10.1016/j.clp.2011.03.008.

    PMID: 21645799BACKGROUND

  • Marin Gabriel MA, Llana Martin I, Lopez Escobar A, Fernandez Villalba E, Romero Blanco I, Touza Pol P. Randomized controlled trial of early skin-to-skin contact: effects on the mother and the newborn. Acta Paediatr. 2010 Nov;99(11):1630-4. doi: 10.1111/j.1651-2227.2009.01597.x.

    PMID: 19912138BACKGROUND

  • Palmer C, Bik EM, DiGiulio DB, Relman DA, Brown PO. Development of the human infant intestinal microbiota. PLoS Biol. 2007 Jul;5(7):e177. doi: 10.1371/journal.pbio.0050177. Epub 2007 Jun 26.

    PMID: 17594176BACKGROUND

  • Lindberg E, Adlerberth I, Hesselmar B, Saalman R, Strannegard IL, Aberg N, Wold AE. High rate of transfer of Staphylococcus aureus from parental skin to infant gut flora. J Clin Microbiol. 2004 Feb;42(2):530-4. doi: 10.1128/JCM.42.2.530-534.2004.

    PMID: 14766812BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Joann M McDermid, MSc PhD RDN

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Joann M. McDermid, MSc, PhD, RDN

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 8, 2017

Study Start

July 27, 2017

Primary Completion

December 20, 2018

Study Completion

December 20, 2018

Last Updated

December 21, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)