Skin-to-skin Contact to Promote Bacterial Decolonization in Preterm Infants
|ClinicalTrials.gov Identifier: NCT01498133|
Recruitment Status : Unknown
Verified December 2011 by Fernando Lamy Filho, Universidade Federal do Maranhão.
Recruitment status was: Active, not recruiting
First Posted : December 23, 2011
Last Update Posted : December 23, 2011
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 or disease||Intervention/treatment||Phase|
|PREMATURITY||Procedure: skin-to skin contact||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||May 2008|
|Primary Completion Date :||November 2010|
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.
- Decolonization of newborns' nostrils [ Time Frame: 7 days ]The primary outcome was decolonization of newborns' nostrils after 7 days of intervention
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498133
|Hospital Universitario Da Universidade Federal Do Maranhao|
|Sao Luis, Maranhao, Brazil, 65020-040|
|Principal Investigator:||Fernando Lamy Filho, PhD||Universidade Federal do Maranhao - Programa de Posgraduação em Saúde Coletiva|