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PREMATURITYPhase 2NCT01498133

Skin-to-skin Contact to Promote Bacterial Decolonization in Preterm Infants

A Phase 2 study testing skin-to skin contact in people with PREMATURITY, run by Universidade Federal do Maranhão at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
PREMATURITY
What is being tested?
skin-to skin contact
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteBrazil
Study dates
May 2008to Nov 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • infants below 1300g and over 1800g,

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Universitario Da Universidade Federal Do Maranhao

    São Luís, Maranhão, 65020-040

Other trials in Brazil

About this study

Official title: Does Skin-to-skin Contact Promote Bacterial Decolonization in Preterm Infants in Neonatal Intensive Care Unit? A Randomized, Single-blinded Controlled Trial

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.

Read more

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)

Conditions
PREMATURITY
Being tested
skin-to skin contact
Keywords
Skin-to-skin contact, Decolonization, MRSA
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • skin-to skin contactProcedure or surgery

    Also called 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.

Study groups in NCT01498133
Study groupRoleWhat they receive
skin-to-skin contactExperimentalNewborns 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).
Receives: Procedure: skin-to skin contact
control groupNo interventionThe control group (n = 49) received routine care without skin-to-skin contact.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decolonization of newborns' nostrils

    The primary outcome was decolonization of newborns' nostrils after 7 days of intervention

    Measured: 7 days

Secondary outcomes (1)

  1. 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.

    Measured: The end of hospitalization period or 28 days of life, whatever happened first.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2011 (estimated)
  2. Study startMay 2008
  3. Primary completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01498133
Sponsor's protocol ID
01
Status last verified
Dec 2011
First submitted
21 Nov 2011
Last updated
23 Dec 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11988712

  • 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.

    PubMed 18270758

  • 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.

    PubMed 16465630

  • 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.

    PubMed 11317239

  • 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.

    PubMed 17878742

  • 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.

    PubMed 14620455

  • 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.

    PubMed 19535174

  • 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.

    PubMed 18923684

  • 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.

    PubMed 16882797

  • 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.

    PubMed 12165580

  • 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.

    PubMed 12168128

  • 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.

    PubMed 19249946

  • 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.

    PubMed 18979408

  • 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.

    PubMed 9570176

  • 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.

    PubMed 14766812

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing skin-to skin contact in people with PREMATURITY, run by Universidade Federal do Maranhão at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decolonization of newborns' nostrils (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01498133, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2011.

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