Clinical trial NCT01498133: Skin-to-skin Contact to Promote Bacterial Decolonization in Preterm Infants
Official title: Does Skin-to-skin Contact Promote Bacterial Decolonization in Preterm Infants in Neonatal Intensive Care Unit? A Randomized, Single-blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: PREMATURITY
Keywords: Skin-to-skin contact
Decolonization
MRSA
Lead sponsor: Universidade Federal do Maranhão
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2011-12-23
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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)


Eligibility 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,

Primary outcomes:
measure: Decolonization of newborns' nostrils
timeFrame: 7 days
Secondary outcomes:
measure: late onset presumed sepsis
timeFrame: The end of hospitalization period or 28 days of life, whatever happened first.
Other outcomes:
Locations:
city: Sao Luis
country: Brazil
facility: Hospital Universitario Da Universidade Federal Do Maranhao
state: Maranhao
Study officials:
affiliation: Universidade Federal do Maranhao - Programa de Posgraduação em Saúde Coletiva
name: Fernando Lamy Filho, PhD
role: PRINCIPAL_INVESTIGATOR
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