Skin-to-skin Contact to Promote Bacterial Decolonization in Preterm Infants
Primary Purpose
PREMATURITY
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
skin-to skin contact
Sponsored by
About this trial
This is an interventional prevention trial for PREMATURITY focused on measuring Skin-to-skin contact, Decolonization, MRSA
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,
Sites / Locations
- Hospital Universitario Da Universidade Federal Do Maranhao
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
skin-to-skin contact
control group
Arm Description
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).
The control group (n = 49) received routine care without skin-to-skin contact.
Outcomes
Primary Outcome Measures
Decolonization of newborns' nostrils
The primary outcome was decolonization of newborns' nostrils after 7 days of intervention
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01498133
First Posted
November 21, 2011
Last Updated
December 20, 2011
Sponsor
Universidade Federal do Maranhão
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT01498133
Brief Title
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
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Maranhão
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PREMATURITY
Keywords
Skin-to-skin contact, Decolonization, MRSA
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
skin-to-skin contact
Arm Type
Experimental
Arm Description
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).
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group (n = 49) received routine care without skin-to-skin contact.
Intervention Type
Procedure
Intervention Name(s)
skin-to skin contact
Other Intervention Name(s)
Kangaroo mother care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decolonization of newborns' nostrils
Description
The primary outcome was decolonization of newborns' nostrils after 7 days of intervention
Time Frame
7 days
Secondary Outcome Measure Information:
Title
late onset presumed sepsis
Description
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.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Lamy Filho, PhD
Organizational Affiliation
Universidade Federal do Maranhao - Programa de Posgraduação em Saúde Coletiva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Da Universidade Federal Do Maranhao
City
Sao Luis
State/Province
Maranhao
ZIP/Postal Code
65020-040
Country
Brazil
12. IPD Sharing Statement
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Skin-to-skin Contact to Promote Bacterial Decolonization in Preterm Infants
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