Skin-to-skin Contact to Promote Bacterial Decolonization in Preterm Infants
This trial is active, not recruiting.
|Treatment||skin-to skin contact|
|Sponsor||Universidade Federal do Maranhão|
|Collaborator||Conselho Nacional de Desenvolvimento Científico e Tecnológico|
|Start date||May 2008|
|End date||November 2010|
|Trial size||102 participants|
|Trial identifier||NCT01498133, 01|
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)
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Decolonization of newborns' nostrils
time frame: 7 days
late onset presumed sepsis
time frame: The end of hospitalization period or 28 days of life, whatever happened first.
Male or female participants of any age.
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,
|Official title||Does Skin-to-skin Contact Promote Bacterial Decolonization in Preterm Infants in Neonatal Intensive Care Unit? A Randomized, Single-blinded Controlled Trial|
|Principal investigator||Fernando Lamy Filho, PhD|
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