A Phase 2 interventional study of skin-to skin contact in PREMATURITY, sponsored by Universidade Federal do Maranhão. Status unknown at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2011-12-23.
Sponsored by Universidade Federal do Maranhão · Phase 2, Interventional, and Prevention
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)
2,615 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's enrollment of 102 is above the median of 84 across 1,722 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
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
The control group (n = 49) received routine care without 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.
Also known as: Kangaroo mother care
Decolonization of newborns' nostrils
The primary outcome was decolonization of newborns' nostrils after 7 days of intervention
Time frame: 7 days
late onset presumed sepsis
The secondary outcome was emergence of late onset presumed sepsis until the end of hospitalization period or 28 days of life, whatever happened first.
Time frame: The end of hospitalization period or 28 days of life, whatever happened first.
This study is status unknown, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Universidade Federal do Maranhão