Skin-to-skin Contact to Promote Bacterial Decolonization in Preterm Infants

December 20, 2011 updated by: Fernando Lamy Filho, Universidade Federal do Maranhão

Does Skin-to-skin Contact Promote Bacterial Decolonization in Preterm Infants in Neonatal Intensive Care Unit? A Randomized, Single-blinded Controlled Trial

BACKGROUND Decolonization with topical antibiotics is necessary to prevent and / or control outbreaks of multidrug-resistant bacterial infection in the NICU (Neonatal Intensive Care Unit), but can trigger bacterial resistance. The objective of this study was to determine whether skin-to-skin contact of newborns colonized with MRSA (Methicillin-Oxacillin Resistant Staphylococcus Aureus) with their mothers could be an effective alternative for biological control of bacterial colonization.

METHODS: The investigators studied 102 newborns admitted to NICU in three public hospitals in São Luís, Brazil. Inclusion criteria were birth weight from 1300 to 1800g, length of stay >4 days, newborns colonized by Staphylococcus aureus and/or Staphylococcus coagulase-negative methicillin-oxacillin resistant and mothers not colonized by these bacteria. Randomization was performed using a computer generated random numbers algorithm. Allocation to intervention and control groups was performed for each eligible newborn using a sealed opaque envelope. In the intervention group (n = 53) mother-infant skin-to-skin contact was held twice a day. The control group (n = 49) received routine care without skin-to-skin contact. There was no masking of newborn's mothers or researchers, but the individuals who carried out bacterial cultures and assessed results were kept blind to group allocation.

The primary outcome was decolonization of newborns' nostrils after 7 days of intervention. Safety was assessed by monitoring vital signs of newborns during the intervention. The secondary outcome was emergence of late onset presumed sepsis until the end of hospitalization period or 28 days of life, whatever happened first.

FUNDING: CNPq (Brazilian Research Council) and FAPEMA (Maranhão Research Foundation)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Maranhao
      • Sao Luis, Maranhao, Brazil, 65020-040
        • Hospital Universitario da Universidade Federal do Maranhao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • singleton neonates,
  • born in the three institutions of the study
  • birth weight from 1300 to 1800g
  • length of stay >=4 days,
  • newborns colonized by Staphylococcus aureus and/or Staphylococcus coagulase-negative methicillin-oxacillin resistant and mothers not colonized by these bacterias.

Exclusion Criteria:

  • infants below 1300g and over 1800g,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: skin-to-skin contact
Newborns in the study group had skin-to-skin contact with their mothers in the NICU, twice a day (morning and evening) for 60 minutes, for seven days (including weekends).
Procedure: skin-to skin contact
Skin-to-skin contact consisted of placing the infant slightly worn (only diapers) in prone decubitus, upright against the mother's breast. The infant was restrained in position by a track that involved him with his/her mother. The mother sat in a chair positioned beside the infants' bed. A team member that accompanied the intervention monitored infants' temperature, heart rate and oxygen saturation.
Other Names:
  • Kangaroo mother care
No Intervention: control group
The control group (n = 49) received routine care without skin-to-skin contact.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decolonization of newborns' nostrils
Time Frame: 7 days
The primary outcome was decolonization of newborns' nostrils after 7 days of intervention
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
late onset presumed sepsis
Time Frame: The end of hospitalization period or 28 days of life, whatever happened first.
The secondary outcome was emergence of late onset presumed sepsis until the end of hospitalization period or 28 days of life, whatever happened first.
The end of hospitalization period or 28 days of life, whatever happened first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Maranhão

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Fernando Lamy Filho, PhD, Universidade Federal do Maranhao - Programa de Posgraduação em Saúde Coletiva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

November 21, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 23, 2011

Study Record Updates

Last Update Posted (Estimate)

December 23, 2011

Last Update Submitted That Met QC Criteria

December 20, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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