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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D060127', 'term': 'Kangaroo-Mother Care Method'}], 'ancestors': [{'id': 'D056888', 'term': 'Patient Positioning'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007224', 'term': 'Infant Care'}, {'id': 'D002654', 'term': 'Child Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'lastUpdateSubmitDate': '2011-12-20', 'studyFirstSubmitDate': '2011-11-21', 'studyFirstSubmitQcDate': '2011-12-20', 'lastUpdatePostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Decolonization of newborns' nostrils", 'timeFrame': '7 days', 'description': "The primary outcome was decolonization of newborns' nostrils after 7 days of intervention"}], 'secondaryOutcomes': [{'measure': 'late onset presumed sepsis', 'timeFrame': 'The end of hospitalization period or 28 days of life, whatever happened first.', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Skin-to-skin contact', 'Decolonization', 'MRSA'], 'conditions': ['PREMATURITY']}, 'referencesModule': {'references': [{'pmid': '11988712', 'type': 'BACKGROUND', 'citation': 'Morel AS, Wu F, Della-Latta P, Cronquist A, Rubenstein D, Saiman L. Nosocomial transmission of methicillin-resistant Staphylococcus aureus from a mother to her preterm quadruplet infants. Am J Infect Control. 2002 May;30(3):170-3. doi: 10.1067/mic.2002.119819.'}, {'pmid': '18270758', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16465630', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11317239', 'type': 'BACKGROUND', 'citation': 'Uehara Y, Kikuchi K, Nakamura T, Nakama H, Agematsu K, Kawakami Y, Maruchi N, Totsuka K. Inhibition of methicillin-resistant Staphylococcus aureus colonization of oral cavities in newborns by viridans group streptococci. Clin Infect Dis. 2001 May 15;32(10):1399-407. doi: 10.1086/320147. Epub 2001 Apr 17.'}, {'pmid': '17878742', 'type': 'BACKGROUND', 'citation': 'Shimizu A, Shimizu K, Nakamura T. Non-pathogenic bacterial flora may inhibit colonization by methicillin-resistant Staphylococcus aureus in extremely low birth weight infants. Neonatology. 2008;93(3):158-61. doi: 10.1159/000108413. Epub 2007 Sep 18.'}, {'pmid': '14620455', 'type': 'BACKGROUND', 'citation': 'Kawada M, Okuzumi K, Hitomi S, Sugishita C. Transmission of Staphylococcus aureus between healthy, lactating mothers and their infants by breastfeeding. J Hum Lact. 2003 Nov;19(4):411-7. doi: 10.1177/0890334403257799.'}, {'pmid': '19535174', 'type': 'BACKGROUND', 'citation': 'Sakaki H, Nishioka M, Kanda K, Takahashi Y. An investigation of the risk factors for infection with methicillin-resistant Staphylococcus aureus among patients in a neonatal intensive care unit. Am J Infect Control. 2009 Sep;37(7):580-6. doi: 10.1016/j.ajic.2009.02.008. Epub 2009 Jun 17.'}, {'pmid': '18923684', 'type': 'BACKGROUND', 'citation': 'Goetghebeur M, Landry PA, Han D, Vicente C. Methicillin-resistant Staphylococcus aureus: A public health issue with economic consequences. Can J Infect Dis Med Microbiol. 2007 Jan;18(1):27-34. doi: 10.1155/2007/253947.'}, {'pmid': '16882797', 'type': 'BACKGROUND', 'citation': 'Huang YC, Chou YH, Su LH, Lien RI, Lin TY. Methicillin-resistant Staphylococcus aureus colonization and its association with infection among infants hospitalized in neonatal intensive care units. Pediatrics. 2006 Aug;118(2):469-74. doi: 10.1542/peds.2006-0254.'}, {'pmid': '12165580', 'type': 'BACKGROUND', 'citation': 'Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, Lemons JA, Donovan EF, Stark AR, Tyson JE, Oh W, Bauer CR, Korones SB, Shankaran S, Laptook AR, Stevenson DK, Papile LA, Poole WK. Late-onset sepsis in very low birth weight neonates: the experience of the NICHD Neonatal Research Network. Pediatrics. 2002 Aug;110(2 Pt 1):285-91. doi: 10.1542/peds.110.2.285.'}, {'pmid': '12168128', 'type': 'BACKGROUND', 'citation': 'Moss W, Darmstadt GL, Marsh DR, Black RE, Santosham M. Research priorities for the reduction of perinatal and neonatal morbidity and mortality in developing country communities. J Perinatol. 2002 Sep;22(6):484-95. doi: 10.1038/sj.jp.7210743.'}, {'pmid': '19249946', 'type': 'BACKGROUND', 'citation': 'McConeghy KW, Mikolich DJ, LaPlante KL. Agents for the decolonization of methicillin-resistant Staphylococcus aureus. Pharmacotherapy. 2009 Mar;29(3):263-80. doi: 10.1592/phco.29.3.263.'}, {'pmid': '18979408', 'type': 'BACKGROUND', 'citation': 'Pinter DM, Mandel J, Hulten KG, Minkoff H, Tosi MF. Maternal-infant perinatal transmission of methicillin-resistant and methicillin-sensitive Staphylococcus aureus. Am J Perinatol. 2009 Feb;26(2):145-51. doi: 10.1055/s-0028-1095179. Epub 2008 Oct 31.'}, {'pmid': '9570176', 'type': 'BACKGROUND', 'citation': "Lindenmayer JM, Schoenfeld S, O'Grady R, Carney JK. Methicillin-resistant Staphylococcus aureus in a high school wrestling team and the surrounding community. Arch Intern Med. 1998 Apr 27;158(8):895-9. doi: 10.1001/archinte.158.8.895."}, {'pmid': '14766812', 'type': 'BACKGROUND', 'citation': 'Lindberg E, Adlerberth I, Hesselmar B, Saalman R, Strannegard IL, Aberg N, Wold AE. High rate of transfer of Staphylococcus aureus from parental skin to infant gut flora. J Clin Microbiol. 2004 Feb;42(2):530-4. doi: 10.1128/JCM.42.2.530-534.2004.'}, {'pmid': '15484804', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19633520', 'type': 'BACKGROUND', 'citation': 'Huang YC, Chao AS, Chang SD, Chen YJ, Peng MT, Sung JH, Chen CJ. Association of Staphylococcus aureus colonization in parturient mothers and their babies. Pediatr Infect Dis J. 2009 Aug;28(8):742-4. doi: 10.1097/INF.0b013e31819c132a.'}, {'pmid': '19519670', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19403471', 'type': 'BACKGROUND', 'citation': 'Gregory ML, Eichenwald EC, Puopolo KM. Seven-year experience with a surveillance program to reduce methicillin-resistant Staphylococcus aureus colonization in a neonatal intensive care unit. Pediatrics. 2009 May;123(5):e790-6. doi: 10.1542/peds.2008-1526.'}, {'pmid': '10348762', 'type': 'BACKGROUND', 'citation': 'Harbarth S, Dharan S, Liassine N, Herrault P, Auckenthaler R, Pittet D. Randomized, placebo-controlled, double-blind trial to evaluate the efficacy of mupirocin for eradicating carriage of methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother. 1999 Jun;43(6):1412-6. doi: 10.1128/AAC.43.6.1412.'}, {'pmid': '25880822', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nMETHODS: 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.\n\nThe 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.\n\nFUNDING: CNPq (Brazilian Research Council) and FAPEMA (Maranhão Research Foundation)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton neonates,\n* born in the three institutions of the study\n* birth weight from 1300 to 1800g\n* length of stay \\>=4 days,\n* newborns colonized by Staphylococcus aureus and/or Staphylococcus coagulase-negative methicillin-oxacillin resistant and mothers not colonized by these bacterias.\n\nExclusion Criteria:\n\n* infants below 1300g and over 1800g,'}, 'identificationModule': {'nctId': 'NCT01498133', 'briefTitle': 'Skin-to-skin Contact to Promote Bacterial Decolonization in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Maranhão'}, 'officialTitle': 'Does Skin-to-skin Contact Promote Bacterial Decolonization in Preterm Infants in Neonatal Intensive Care Unit? A Randomized, Single-blinded Controlled Trial', 'orgStudyIdInfo': {'id': '01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'skin-to-skin contact', '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).', 'interventionNames': ['Procedure: skin-to skin contact']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'The control group (n = 49) received routine care without skin-to-skin contact.'}], 'interventions': [{'name': 'skin-to skin contact', 'type': 'PROCEDURE', 'otherNames': ['Kangaroo mother care'], '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.", 'armGroupLabels': ['skin-to-skin contact']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65020-040', 'city': 'São Luís', 'state': 'Maranhão', 'country': 'Brazil', 'facility': 'Hospital Universitario Da Universidade Federal Do Maranhao', 'geoPoint': {'lat': -2.52972, 'lon': -44.30278}}], 'overallOfficials': [{'name': 'Fernando Lamy Filho, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Maranhao - Programa de Posgraduação em Saúde Coletiva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Maranhão', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fernando Lamy Filho', 'investigatorAffiliation': 'Universidade Federal do Maranhão'}}}}