Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-30 @ 12:19 PM
Study NCT ID:
NCT01498133
Status:
UNKNOWN
Last Update Posted:
2011-12-23
First Post:
2011-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin-to-skin Contact to Promote Bacterial Decolonization in Preterm Infants
Sponsor:
Universidade Federal do Maranhão
Organization:
Study Overview
Official Title:
Does Skin-to-skin Contact Promote Bacterial Decolonization in Preterm Infants in Neonatal Intensive Care Unit? A Randomized, Single-blinded Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2011-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: