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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Fernando Lamy Filho, Universidade Federal do Maranhão
ClinicalTrials.gov Identifier:
NCT01498133
First received: November 21, 2011
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

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)


Condition Intervention Phase
PREMATURITY
 Procedure: skin-to skin contact
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Skin-to-skin Contact Promote Bacterial Decolonization in Preterm Infants in Neonatal Intensive Care Unit? A Randomized, Single-blinded Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade Federal do Maranhão:

Primary Outcome Measures:
  • Decolonization of newborns' nostrils [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    The primary outcome was decolonization of newborns' nostrils after 7 days of intervention


Secondary Outcome Measures:
  • late onset presumed sepsis [ Time Frame: The end of hospitalization period or 28 days of life, whatever happened first. ] [ Designated as safety issue: Yes ]
    The secondary outcome was emergence of late onset presumed sepsis until the end of hospitalization period or 28 days of life, whatever happened first.


Enrollment: 102
Study Start Date: May 2008
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Kangaroo mother care
No Intervention: control group
The control group (n = 49) received routine care without skin-to-skin contact.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498133

Locations
Brazil
Hospital Universitario Da Universidade Federal Do Maranhao
Sao Luis, Maranhao, Brazil, 65020-040
Sponsors and Collaborators
Universidade Federal do Maranhão
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Fernando Lamy Filho, PhD Universidade Federal do Maranhao - Programa de Posgraduação em Saúde Coletiva
  More Information

Publications:

Responsible Party: Fernando Lamy Filho, Principal Investigator, Universidade Federal do Maranhão
ClinicalTrials.gov Identifier: NCT01498133     History of Changes
Other Study ID Numbers: 01
Study First Received: November 21, 2011
Last Updated: December 20, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal do Maranhão:
Skin-to-skin contact
Decolonization
MRSA

ClinicalTrials.gov processed this record on May 23, 2013