Overview

This trial is active, not recruiting.

Condition prematurity
Treatment skin-to skin contact
Phase phase 2
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

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
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).
skin-to skin contact Kangaroo mother care
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.
(No Intervention)
The control group (n = 49) received routine care without skin-to-skin contact.

Primary Outcomes

Measure
Decolonization of newborns' nostrils
time frame: 7 days

Secondary Outcomes

Measure
late onset presumed sepsis
time frame: The end of hospitalization period or 28 days of life, whatever happened first.

Eligibility Criteria

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,

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by Universidade Federal do Maranhão.