Skin-to-skin Contact to Promote Bacterial Decolonization in Preterm Infants
NCT ID: NCT01498133
Last Updated: 2011-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
102 participants
INTERVENTIONAL
2008-05-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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).
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.
control group
The control group (n = 49) received routine care without skin-to-skin contact.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
ALL
Yes
Sponsors
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Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Universidade Federal do Maranhão
OTHER
Responsible Party
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Fernando Lamy Filho
Principal Investigator
Principal Investigators
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Fernando Lamy Filho, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade Federal do Maranhao - Programa de Posgraduação em Saúde Coletiva
Locations
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Hospital Universitario Da Universidade Federal Do Maranhao
São Luís, Maranhão, Brazil
Countries
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References
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Humphreys H. Can we do better in controlling and preventing methicillin-resistant Staphylococcus aureus (MRSA) in the intensive care unit (ICU)? Eur J Clin Microbiol Infect Dis. 2008 Jun;27(6):409-13. doi: 10.1007/s10096-008-0469-7. Epub 2008 Feb 13.
Gerber SI, Jones RC, Scott MV, Price JS, Dworkin MS, Filippell MB, Rearick T, Pur SL, McAuley JB, Lavin MA, Welbel SF, Garcia-Houchins S, Bova JL, Weber SG, Arnow PM, Englund JA, Gavin PJ, Fisher AG, Thomson RB, Vescio T, Chou T, Johnson DC, Fry MB, Molloy AH, Bardowski L, Noskin GA. Management of outbreaks of methicillin-resistant Staphylococcus aureus infection in the neonatal intensive care unit: a consensus statement. Infect Control Hosp Epidemiol. 2006 Feb;27(2):139-45. doi: 10.1086/501216. Epub 2006 Feb 8.
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Behari P, Englund J, Alcasid G, Garcia-Houchins S, Weber SG. Transmission of methicillin-resistant Staphylococcus aureus to preterm infants through breast milk. Infect Control Hosp Epidemiol. 2004 Sep;25(9):778-80. doi: 10.1086/502476.
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Mori R, Khanna R, Pledge D, Nakayama T. Meta-analysis of physiological effects of skin-to-skin contact for newborns and mothers. Pediatr Int. 2010 Apr;52(2):161-70. doi: 10.1111/j.1442-200X.2009.02909.x. Epub 2009 Jun 11.
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Lamy Filho F, de Sousa SH, Freitas IJ, Lamy ZC, Simoes VM, da Silva AA, Barbieri MA. Effect of maternal skin-to-skin contact on decolonization of Methicillin-Oxacillin-Resistant Staphylococcus in neonatal intensive care units: a randomized controlled trial. BMC Pregnancy Childbirth. 2015 Mar 19;15:63. doi: 10.1186/s12884-015-0496-1.
Other Identifiers
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01
Identifier Type: -
Identifier Source: org_study_id