Lamy Filho Fernando, de Sousa Sílvia Helena Cavalcante, Freitas Isolina Januária Sousa, Lamy Zeni Carvalho, Simões Vanda Maria Ferreira, da Silva Antônio Augusto Moura, Barbieri Marco Antônio
Departamento de Saúde Pública, Universidade Federal do Maranhão, Rua Barão de Itapary, 155, Centro, São Luís, Maranhão, Brazil.
Departamento de Puericultura e Pediatria (7° andar HCRP), Faculdade de Medicina de Ribeirão Preto - USP, Universidade de São Paulo, Av. Bandeirantes, 3900 - Campus USP, Ribeirão Preto, Brazil.
BMC Pregnancy Childbirth. 2015 Mar 19;15:63. doi: 10.1186/s12884-015-0496-1.
Decolonization with topical antibiotics is necessary to control outbreaks of multidrug-resistant bacterial infection in the Neonatal Intensive Care Unit (NICU), but can trigger bacterial resistance. The objective of this study was to determine whether skin-to-skin contact of newborns colonized with Methicillin-Oxacillin Resistant Staphylococcus aureus or Methicillin-Oxacillin-Resistant Coagulase-Negative Staphylococcus aureus (MRSA/MRSE) with their mothers could be an effective alternative to promote bacterial decolonization of newborns' nostrils.
We performed a randomized clinical trial with 102 newborns admitted to the NICU in three hospitals in São Luís, Brazil. Inclusion criteria were birth weight of 1300 to 1800 g, more than 4 days of hospitalization, newborns with positive nostril cultures for MRSA and/or multidrug-resistant coagulase-negative Staphylococcus and mothers not colonized by these bacteria. We used a random number algorithm for randomization. Allocation was performed using sealed opaque envelopes. Skin-to-skin contact was given twice a day for 60 minutes for seven consecutive days. The control group 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 colonization status of newborns' nostrils after 7 days of intervention. The directional hypothesis was that more newborns who receive skin-to-skin holding 2 hours/day for 7 days than newborns who receive normal care will be decolonized.
Decolonization of MRSA/MRSE was greater in the intervention group (Risk Ratio = 2.27; 95% CI 1.27-4.07, p-value = 0.003). Number Needed to Treat (NNT) was 4.0 (95% CI 2.2 - 9.4). After adjustment for the possible confounding effects of small for gestational age birth, antibiotic use, need for resuscitation, sex and cesarean delivery, skin-to-skin contact remained strongly associated with decolonization of newborns' nostrils from MRSA/MRSE bacteria (p = 0.007). There was no need to interrupt the trial for safety reasons.
Skin-to-skin contact might be an effective and safe method for promoting decolonization of newborns' nostrils colonized by MRSA/MRSE.
The study was registered with ClinicalTrials.gov ( NCT01498133 , November 21, 2011).
使用局部抗生素进行去定植对于控制新生儿重症监护病房(NICU)中多重耐药细菌感染的暴发是必要的,但可能会引发细菌耐药性。本研究的目的是确定携带耐甲氧西林金黄色葡萄球菌或耐甲氧西林凝固酶阴性葡萄球菌(MRSA/MRSE)的新生儿与其母亲进行皮肤接触是否可以作为促进新生儿鼻腔细菌去定植的有效替代方法。
我们在巴西圣路易斯市三家医院的新生儿重症监护病房对102名新生儿进行了一项随机临床试验。纳入标准为出生体重1300至1800克、住院超过4天、鼻腔培养出MRSA和/或多重耐药凝固酶阴性葡萄球菌呈阳性的新生儿以及未被这些细菌定植的母亲。我们使用随机数字算法进行随机分组。分配使用密封不透明信封进行。连续7天每天进行两次皮肤接触,每次60分钟。对照组接受无皮肤接触的常规护理。新生儿母亲或研究人员不设盲,但进行细菌培养和评估结果的人员对分组情况不知情。主要结局是干预7天后新生儿鼻腔的定植状态。定向假设是,每天接受2小时皮肤接触、持续7天的新生儿比接受常规护理的新生儿去定植的更多。
干预组中MRSA/MRSE的去定植情况更好(风险比=2.27;95%置信区间1.27 - 4.07,p值=0.003)。治疗所需人数(NNT)为4.0(95%置信区间2.2 - 9.4)。在对小于胎龄出生、抗生素使用、复苏需求、性别和剖宫产等可能的混杂效应进行调整后,皮肤接触与新生儿鼻腔中MRSA/MRSE细菌的去定植仍密切相关(p=0.007)。无需因安全原因中断试验。
皮肤接触可能是促进被MRSA/MRSE定植的新生儿鼻腔去定植的一种有效且安全的方法。
该研究已在ClinicalTrials.gov注册(NCT01498133,2011年11月21日)。