Background
Lactoferrin, a normal component of human colostrum and milk, can enhance host defenses and may be effective for prevention of sepsis and necrotizing enterocolitis (NEC) in preterm ...neonates.
Objectives
To assess the safety and effectiveness of lactoferrin supplementation to enteral feeds for prevention of sepsis and NEC in preterm neonates. Secondarily, we assessed the effects of lactoferrin supplementation to enteral feeds on the duration of positive‐pressure ventilation, development of chronic lung disease (CLD) or periventricular leukomalacia (PVL), length of hospital stay to discharge among survivors, and adverse neurological outcomes at two years of age or later.
Search methods
We used the standard search strategy of Cochrane Neonatal to update our search. We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2019, Issue 9), MEDLINE via PubMed (1966 to 20 January 2020), PREMEDLINE (1996 to 20 January 2020), Embase (1980 to 20 January 2020), and CINAHL (1982 to 20 January 2020). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi‐randomized trials.
Selection criteria
In our search, we included randomized controlled trials (RCTs) evaluating enteral lactoferrin supplementation at any dose or duration to prevent sepsis or NEC in preterm neonates.
Data collection and analysis
We used the standard methods of Cochrane Neonatal and the GRADE approach to assess the certainty of evidence.
Main results
Meta‐analysis of data from twelve randomized controlled trials showed that lactoferrin supplementation to enteral feeds decreased suspected or confirmed late‐onset sepsis (typical RR 0.80, 95% CI 0.72 to 0.89; typical RD ‐0.05, 95% CI, ‐0.07 to ‐0.02; NNTB 20, 95% CI 14 to 50; 12 studies, 5425 participants, low‐certainty evidence) and decreased length of hospital stay (MD ‐2.38 to 95% CI, ‐4.67 to ‐0.09; 3 studies, 1079 participants, low‐certainty evidence). A subgroup analysis including data of infants with confirmed sepsis demonstrates a decrease in confirmed late‐onset sepsis (typical RR 0.83, 95% CI 0.73 to 0.94; typical RD ‐0.03, 95% CI, ‐0.04 to ‐0.01; NNTB 33, 95% CI 25 to 100; 12 studies, 5425 participants, low‐certainty evidence).
Sensitivity analysis including only good methodological certainty studies suggested a decrease in late‐onset sepsis (both suspected and confirmed) with enteral lactoferrin supplementation (typical RR 0.82, 95% CI, 0.74 to 0.91; typical RD ‐0.04, 95% CI, ‐0.06 to ‐0.02; NNTB 20, 95% CI 14 to 50; 9 studies, 4702 participants, low‐certainty evidence).
There were no differences in NEC stage II or III (typical RR 1.10, 95% CI, 0.86 to 1.41; typical RD ‐0.00, 95% CI, ‐0.02 to 0.01; 7 studies, 4874 participants; low‐certainty evidence) or 'all‐cause mortality' (typical RR 0.90, 95% CI 0.69 to 1.17; typical RD ‐0.00, 95% CI, ‐0.01 to 0.01; 11 studies, 5510 participants; moderate‐certainty evidence). One study reported no differences in neurodevelopmental testing by Mullen's or Bayley III at 24 months of age after enteral lactoferrin supplementation (one study, 292 participants, low‐certainty evidence).
Lactoferrin supplementation to enteral feeds with probiotics decreased late‐onset sepsis (RR 0.25, 95% CI 0.14 to 0.46; RD ‐0.13, 95% CI ‐0.18 to ‐0.08; NNTB 8, 95% CI 6 to 13; 3 studies, 564 participants; low‐certainty evidence) and NEC stage II or III (RR 0.04, 95% CI 0.00 to 0.62; RD ‐0.05, 95% CI ‐0.08 to ‐0.03; NNTB 20, 95% CI 12.5 to 33.3; 1 study, 496 participants; very low‐certainty evidence), but not 'all‐cause mortality' (very low‐certainty evidence).
Lactoferrin supplementation to enteral feeds with or without probiotics had no effect on CLD, duration of mechanical ventilation or threshold retinopathy of prematurity (low‐certainty evidence). Investigators reported no adverse effects in the included studies.
Authors' conclusions
We found low‐certainty evidence from studies of good methodological quality that lactoferrin supplementation of enteral feeds decreases late‐onset sepsis (both suspected and confirmed, and confirmed only) but not NEC ≥ stage II or 'all cause mortality' or neurodevelopmental outcomes at 24 months of age in preterm infants without adverse effects. Low‐ to very low‐certainty evidence suggests that lactoferrin supplementation of enteral feeds in combination with probiotics decreases late‐onset sepsis (data from confirmed sepsis only) and NEC ≥ stage II in preterm infants without adverse effects, however, there were few included studies of poor methodological quality. The presence of publication bias and small studies of poor methodology that may inflate the effect size make recommendations for clinical practice difficult.
Background
Lactoferrin, a normal component of human colostrum and milk, can enhance host defenses and may be effective for prevention of sepsis and necrotizing enterocolitis (NEC) in preterm ...neonates.
Objectives
Primary objective
1. To assess the safety and effectiveness of lactoferrin supplementation to enteral feeds for prevention of sepsis and NEC in preterm neonates
Secondary objectives
1. To determine the effects of lactoferrin supplementation to enteral feeds to prevent neonatal sepsis and/or NEC on duration of positive‐pressure ventilation, development of chronic lung disease (CLD) or periventricular leukomalacia (PVL), length of hospital stay to discharge among survivors, and adverse neurological outcomes at two years of age or later
2. To determine the adverse effects of lactoferrin supplementation for prophylaxis of neonatal sepsis and/or NEC
When data were available, we analyzed the following subgroups.
1. Gestational age < 32 weeks and 32 to 36 weeks
2. Birth weight < 1000 g (extremely low birth weight (ELBW) infants) and birth weight < 1500 g (very low birth weight (VLBW) infants)
3. Type of feeding: breast milk versus formula milk
Search methods
We used the search strategy of the Cochrane Neonatal Review Group (CNRG) to update our search in December 2016. We searched the databases Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PREMEDLINE, Embase, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), as well as trial registries and conference proceedings.
Selection criteria
Randomized controlled trials (RCTs) evaluating oral lactoferrin at any dose or duration to prevent sepsis or NEC in preterm neonates.
Data collection and analysis
Review authors used standard methods of the CNRG.
Main results
This review includes six RCTs. Trial results show that lactoferrin supplementation to enteral feeds decreased late‐onset sepsis (typical risk ratio (RR) 0.59, 95% confidence interval (CI) 0.40 to 0.87; typical risk difference (RD) ‐0.06, 95% CI ‐0.10 to ‐0.02; number needed to treat for an additional beneficial outcome (NNTB) 17, 95% CI 10 to 50; six trials, 886 participants; low‐quality evidence) and NEC stage II or III (typical RR 0.40, 95% CI 0.18 to 0.86; typical RD ‐0.04, 95% CI ‐0.06 to ‐0.01; NNTB 25, 95% CI 17 to 100; four studies, 750 participants; low‐quality evidence). Lactoferrin supplementation did not have an effect on "all‐cause mortality" (typical RR 0.65, 95% CI 0.37 to 1.11; typical RD ‐0.02, 95% CI ‐0.05 to 0; six studies, 1041 participants; low‐quality evidence).
Lactoferrin supplementation to enteral feeds with probiotics decreased late‐onset sepsis (RR 0.27, 95% CI 0.12 to 0.60; RD ‐0.13, 95% CI ‐0.19 to ‐0.06; NNTB 8, 95% CI 5 to 17; one study, 321 participants; low‐quality evidence) and NEC stage II or III (RR 0.04, 95% CI 0.00 to 0.62; RD ‐0.05, 95% CI ‐0.08 to ‐0.03; NNTB 20, 95% CI 12.5 to 33.3; one study, 496 participants; low‐quality evidence), but not "all‐cause mortality" (low‐quality evidence).
Lactoferrin supplementation to enteral feeds with or without probiotics decreased bacterial and fungal sepsis but not CLD or length of hospital stay (low‐quality evidence). Investigators reported no adverse effects and did not evaluate long‐term neurological outcomes and PVL.
Authors' conclusions
Evidence of low quality suggests that lactoferrin supplementation to enteral feeds with or without probiotics decreases late‐onset sepsis and NEC stage II or III in preterm infants without adverse effects. Completed ongoing trials will provide data from more than 6000 preterm neonates, which may enhance the quality of the evidence. Clarification regarding optimal dosing regimens, types of lactoferrin (human or bovine), and long‐term outcomes is needed.
Background
Necrotizing enterocolitis (NEC) and nosocomial sepsis are associated with increased morbidity and mortality in preterm infants. Through prevention of bacterial migration across the mucosa, ...competitive exclusion of pathogenic bacteria, and enhancing the immune responses of the host, prophylactic enteral probiotics (live microbial supplements) may play a role in reducing NEC and the associated morbidity.
Objectives
To compare the efficacy and safety of prophylactic enteral probiotics administration versus placebo or no treatment in the prevention of severe NEC or sepsis, or both, in preterm infants.
Search methods
For this update, searches were made of MEDLINE (1966 to October 2013), EMBASE (1980 to October 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2013, Issue 10), and s of annual meetings of the Society for Pediatric Research (1995 to 2013).
Selection criteria
Only randomized or quasi‐randomized controlled trials that enrolled preterm infants < 37 weeks gestational age or < 2500 g birth weight, or both, were considered. Trials were included if they involved enteral administration of any live microbial supplement (probiotics) and measured at least one prespecified clinical outcome.
Data collection and analysis
Standard methods of The Cochrane Collaboration and its Neonatal Group were used to assess the methodologic quality of the trials and for data collection and analysis.
Main results
Twenty‐four eligible trials were included. Included trials were highly variable with regard to enrolment criteria (that is birth weight and gestational age), baseline risk of NEC in the control groups, timing, dose, formulation of the probiotics, and feeding regimens. In a meta‐analysis of trial data, enteral probiotics supplementation significantly reduced the incidence of severe NEC (stage II or more) (typical relative risk (RR) 0.43, 95% confidence interval (CI) 0.33 to 0.56; 20 studies, 5529 infants) and mortality (typical RR 0.65, 95% CI 0.52 to 0.81; 17 studies, 5112 infants). There was no evidence of significant reduction of nosocomial sepsis (typical RR 0.91, 95% CI 0.80 to 1.03; 19 studies, 5338 infants). The included trials reported no systemic infection with the supplemental probiotics organism. Probiotics preparations containing either lactobacillus alone or in combination with bifidobacterium were found to be effective.
Authors' conclusions
Enteral supplementation of probiotics prevents severe NEC and all cause mortality in preterm infants. Our updated review of available evidence strongly supports a change in practice. Head to head comparative studies are required to assess the most effective preparations, timing, and length of therapy to be utilized.
Background
Rotavirus results in more diarrhoea‐related deaths in children under five years than any other single agent in countries with high childhood mortality. It is also a common cause of ...diarrhoea‐related hospital admissions in countries with low childhood mortality. Rotavirus vaccines that have been prequalified by the World Health Organization (WHO) include a monovalent vaccine (RV1; Rotarix, GlaxoSmithKline), a pentavalent vaccine (RV5; RotaTeq, Merck), and, more recently, another monovalent vaccine (Rotavac, Bharat Biotech).
Objectives
To evaluate rotavirus vaccines prequalified by the WHO (RV1, RV5, and Rotavac) for their efficacy and safety in children.
Search methods
On 4 April 2018 we searched MEDLINE (via PubMed), the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (published in the Cochrane Library), Embase, LILACS, and BIOSIS. We also searched the WHO ICTRP, ClinicalTrials.gov, clinical trial reports from manufacturers' websites, and reference lists of included studies and relevant systematic reviews.
Selection criteria
We selected randomized controlled trials (RCTs) in children comparing rotavirus vaccines prequalified for use by the WHO versus placebo or no intervention.
Data collection and analysis
Two review authors independently assessed trial eligibility and assessed risks of bias. One review author extracted data and a second author cross‐checked them. We combined dichotomous data using the risk ratio (RR) and 95% confidence interval (CI). We stratified the analysis by country mortality rate and used GRADE to evaluate evidence certainty.
Main results
Fifty‐five trials met the inclusion criteria and enrolled a total of 216,480 participants. Thirty‐six trials (119,114 participants) assessed RV1, 15 trials (88,934 participants) RV5, and four trials (8432 participants) Rotavac.
RV1
Children vaccinated and followed up the first year of life
In low‐mortality countries, RV1 prevents 84% of severe rotavirus diarrhoea cases (RR 0.16, 95% CI 0.09 to 0.26; 43,779 participants, 7 trials; high‐certainty evidence), and probably prevents 41% of cases of severe all‐cause diarrhoea (RR 0.59, 95% CI 0.47 to 0.74; 28,051 participants, 3 trials; moderate‐certainty evidence). In high‐mortality countries, RV1 prevents 63% of severe rotavirus diarrhoea cases (RR 0.37, 95% CI 0.23 to 0.60; 6114 participants, 3 trials; high‐certainty evidence), and 27% of severe all‐cause diarrhoea cases (RR 0.73, 95% CI 0.56 to 0.95; 5639 participants, 2 trials; high‐certainty evidence).
Children vaccinated and followed up for two years
In low‐mortality countries, RV1 prevents 82% of severe rotavirus diarrhoea cases (RR 0.18, 95% CI 0.14 to 0.23; 36,002 participants, 9 trials; high‐certainty evidence), and probably prevents 37% of severe all‐cause diarrhoea episodes (rate ratio 0.63, 95% CI 0.56 to 0.71; 39,091 participants, 2 trials; moderate‐certainty evidence). In high‐mortality countries RV1 probably prevents 35% of severe rotavirus diarrhoea cases (RR 0.65, 95% CI 0.51 to 0.83; 13,768 participants, 2 trials; high‐certainty evidence), and 17% of severe all‐cause diarrhoea cases (RR 0.83, 95% CI 0.72 to 0.96; 2764 participants, 1 trial; moderate‐certainty evidence).
No increased risk of serious adverse events (SAE) was detected (RR 0.88 95% CI 0.83 to 0.93; high‐certainty evidence). There were 30 cases of intussusception reported in 53,032 children after RV1 vaccination and 28 cases in 44,214 children after placebo or no intervention (RR 0.70, 95% CI 0.46 to 1.05; low‐certainty evidence).
RV5
Children vaccinated and followed up the first year of life
In low‐mortality countries, RV5 probably prevents 92% of severe rotavirus diarrhoea cases (RR 0.08, 95% CI 0.03 to 0.22; 4132 participants, 5 trials; moderate‐certainty evidence). We did not identify studies reporting on severe all‐cause diarrhoea in low‐mortality countries. In high‐mortality countries, RV5 prevents 57% of severe rotavirus diarrhoea (RR 0.43, 95% CI 0.29 to 0.62; 5916 participants, 2 trials; high‐certainty evidence), but there is probably little or no difference between vaccine and placebo for severe all‐cause diarrhoea (RR 0.80, 95% CI 0.58 to 1.11; 1 trial, 4085 participants; moderate‐certainty evidence).
Children vaccinated and followed up for two years
In low‐mortality countries, RV5 prevents 82% of severe rotavirus diarrhoea cases (RR 0.18, 95% CI 0.08 to 0.39; 7318 participants, 4 trials; moderate‐certainty evidence). We did not identify studies reporting on severe all‐cause diarrhoea in low‐mortality countries. In high‐mortality countries, RV5 prevents 41% of severe rotavirus diarrhoea cases (RR 0.59, 95% CI 0.43 to 0.82; 5885 participants, 2 trials; high‐certainty evidence), and 15% of severe all‐cause diarrhoea cases (RR 0.85, 95% CI 0.75 to 0.98; 5977 participants, 2 trials; high‐certainty evidence).
No increased risk of serious adverse events (SAE) was detected (RR 0.93 95% CI 0.86 to 1.01; moderate to high‐certainty evidence). There were 16 cases of intussusception in 43,629 children after RV5 vaccination and 20 cases in 41,866 children after placebo (RR 0.77, 95% CI 0.41 to 1.45; low‐certainty evidence).
Rotavac
Children vaccinated and followed up the first year of life
Rotavac has not been assessed in any RCT in countries with low child mortality. In India, a high‐mortality country, Rotavac probably prevents 57% of severe rotavirus diarrhoea cases (RR 0.43, 95% CI 0.30 to 0.60; 6799 participants, moderate‐certainty evidence); the trial did not report on severe all‐cause diarrhoea at one‐year follow‐up.
Children vaccinated and followed up for two years
Rotavac probably prevents 54% of severe rotavirus diarrhoea cases in India (RR 0.46, 95% CI 0.35 to 0.60; 6541 participants, 1 trial; moderate‐certainty evidence), and 16% of severe all‐cause diarrhoea cases (RR 0.84, 95% CI 0.71 to 0.98; 6799 participants, 1 trial; moderate‐certainty evidence).
No increased risk of serious adverse events (SAE) was detected (RR 0.93 95% CI 0.85 to 1.02; moderate‐certainty evidence). There were eight cases of intussusception in 5764 children after Rotavac vaccination and three cases in 2818 children after placebo (RR 1.33, 95% CI 0.35 to 5.02; very low‐certainty evidence).
There was insufficient evidence of an effect on mortality from any rotavirus vaccine (198,381 participants, 44 trials; low‐ to very low‐certainty evidence), as the trials were not powered to detect an effect at this endpoint.
Authors' conclusions
RV1, RV5, and Rotavac prevent episodes of rotavirus diarrhoea. Whilst the relative effect estimate is smaller in high‐mortality than in low‐mortality countries, there is a greater number of episodes prevented in these settings as the baseline risk is much higher. We found no increased risk of serious adverse events.
21 October 2019
Up to date
All studies incorporated from most recent search
All published trials found in the last search (4 Apr, 2018) were included and 15 ongoing studies are currently awaiting completion (see 'Characteristics of ongoing studies').
Background
Neonatal healthcare‐associated infections (HAIs) result in increased morbidity and mortality, as well as increased healthcare costs. Patient isolation measures, i.e. single‐room isolation ...or the cohorting of patients with similar infections, remain a recommended and commonly used practice for preventing horizontal spread of infections in the neonatal intensive care unit (NICU).
Objectives
Our primary objective was to assess the effect of single‐room isolation or cohorting, or both for preventing transmission of HAIs or colonization with HAI‐causing pathogens in newborn infants less than six months of age admitted to the neonatal intensive care unit (NICU).
Our secondary objective was to assess the effect of single‐room isolation or cohorting, or both on neonatal mortality and perceived or documented adverse effects in newborn infants admitted to the NICU.
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, the WHO ICTRP and ClinicalTrials.gov trials registries. There were no restrictions to date, language or publication type. We also checked the reference lists of studies identified for full‐text review.
Selection criteria
Types of studies: cluster‐randomized or quasi‐randomized trials at the level of the cluster (where clusters may be defined by NICU, hospital, ward, or other subunits of the hospital). We also included cross‐over trials with a washout period of more than four months (arbitrarily defined).
Types of participants: newborn infants less than six months of age in neonatal units that implemented patient isolation or cohorting as infection control measures to prevent HAIs.
Types of interventions: patient isolation measures (single‐room isolation or cohorting, or both of infants with similar colonization or infections) compared to routine isolation measures.
Types of outcome measures: the primary outcome was the rate of transmission of HAIs as estimated by the infection and colonization rates in the NICU. Secondary outcomes included all‐cause mortality during hospital stay at 28 days of age, length of hospital stay, as well as potential adverse effects of isolation or cohorting measures, or both.
Data collection and analysis
The standard methods of Cochrane Neonatal were used to identify studies and assess the methodological quality of eligible cluster‐randomized trials. The certainty of the evidence was to be assessed by the GRADE method as evidence of high, moderate, low, or very low certainty. Infection and colonization rates were to be expressed as rate ratios for each trial and if appropriate for meta‐analysis, the generic inverse variance method in RevMan was to be used.
Main results
We did not identify any published or ongoing trials to include in the review.
Authors' conclusions
The review found no evidence from randomized trials to either support or refute the use of patient isolation measures (single‐room isolation or cohorting) in neonates with HAIs. Risks secondary to infection control measures need to be balanced against the benefits of decreasing horizontal transmission in the neonatal unit for optimal neonatal outcomes. There is an urgent need to research the effectiveness of patient isolation measures for preventing the transmission of HAIs in neonatal units. Well‐designed trials randomizing clusters of units or hospitals to a type of patient isolation method intervention are warranted.
Background
Annually, infections contribute to approximately 25% of the 2.8 million neonatal deaths worldwide. Over 95% of sepsis‐related neonatal deaths occur in low‐ and middle‐income countries. ...Hand hygiene is an inexpensive and cost‐effective method of preventing infection in neonates, making it an affordable and practicable intervention in low‐ and middle‐income country settings. Therefore, hand hygiene practices may hold strong prospects for reducing the occurrence of infection and infection‐related neonatal death.
Objectives
To determine the effectiveness of different hand hygiene agents for preventing neonatal infection in both community and health facility settings.
Search methods
Searches were conducted without date or language limits in December 2022 in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and Cumulated Index to Nursing and Allied Health Literature (CINAHL), clinicaltrials.gov and International Clinical Trials Registry Platform (ICTRP) trial registries. The reference lists of retrieved studies or related systematic reviews were screened for studies not identified by the searches.
Selection criteria
We included randomized controlled trials (RCTs), cross‐over trials, and cluster trials that included pregnant women, mothers, other caregivers, and healthcare workers who received interventions within either the community setting or in health facility settings, and the neonates in the neonatal care units or community settings.
Data collection and analysis
We used standard methodological procedures expected by Cochrane and the GRADE approach to assess the certainty of evidence. Primary outcomes were incidence of suspected infection (author‐defined in study) within the first 28 days of life, bacteriologically confirmed infection within the first 28 days of life, all‐cause mortality within the first seven days of life (early neonatal death), and all‐cause mortality from the 8th to the 28th day of life (late neonatal death).
Main results
Our review included six studies: two RCTs, one cluster‐RCT, and three cross‐over trials. Three studies involved 3281 neonates; the remaining three did not specify the actual number of neonates included in their study. Three studies involved 279 nurses working in neonatal intensive care units (NICUs). The number of nurses included was not specified by one study. A cluster‐RCT included 103 pregnant women of over 34 weeks gestation from 10 villages in a community setting (sources of data: 103 mother‐neonate pairs) and another community‐based study included 258 married pregnant women at 32 to 34 weeks of gestation (the trial reported adverse events on 258 mothers and 246 neonates). Studies examined the effectiveness of different hand hygiene practices for the incidence of suspected infection (author‐defined in study) within the first 28 days of life. Three studies were rated as having low risk for allocation bias, two studies were rated as unclear risk, and one was rated as having high risk. One study was rated as having a low risk of bias for allocation concealment, one study was rated as unclear risk, and four werw rated as having high risk. Two studies were rated as having low risk for performance bias and two were rated as having low risk for attrition bias.
One class of agent versus another class of agent: 2% chlorhexidine gluconate (CHG) compared to alcohol hand sanitiser (61% alcohol and emollients)
For this comparison, no study assessed the effect of the intervention on the incidence of suspected infection within the first 28 days of life. Two percent chlorhexidine gluconate (CHG) probably reduces the risk of all infection in neonates compared to 61% alcohol hand sanitiser in regard to the incidence of all bacteriologically confirmed infection within the first 28 days of life (RR 0.79, 95% confidence interval (CI) 0.66 to 0.93; 2932 participants, 1 study; moderate‐certainty evidence), number needed to treat for an additional beneficial outcome (NNTB): 385.
The adverse outcome was reported as mean self‐reported skin change and mean observer‐reported skin change. There may be little to no difference between the effects of 2% CHG on nurses’ skin compared to alcohol hand sanitiser, based on very low‐certainty evidence for mean self‐reported skin change (mean difference (MD) ‐0.80, 95% CI ‐1.59 to 0.01; 119 participants, 1 study) and on mean observer reported skin change (MD ‐0.19, CI ‐0.35 to ‐0.03; 119 participants, 1 study), respectively.
We identified no study that reported on all‐cause mortality and other outcomes for this comparison.
None of the included studies assessed all‐cause mortality within the first seven days of life nor the duration of hospital stay.
One class of agent versus two or more other classes of agent: CHG compared to plain liquid soap + hand sanitiser
We identified no studies that reported on our primary and secondary outcomes for this comparison except for author‐defined adverse events. We are very uncertain whether plain soap plus hand sanitiser is better than CHG for nurses’ skin based on very low‐certainty evidence (MD ‐1.87, 95% CI ‐3.74 to ‐0.00; 16 participants, 1 study; very low‐certainty evidence).
One agent versus standard care: alcohol‐based handrub (hand sanitiser) versus usual care
The evidence is very uncertain whether alcohol‐based handrub is better than 'usual care' in the prevention of suspected infections, as reported by mothers (RR 0.98, CI 0.69 to 1.39; 103 participants, 1 study, very low‐certainty evidence). We are uncertain whether alcohol‐based hand sanitiser is better than 'usual care' in reducing the occurrence of early and late neonatal mortality (RR 0.29, 95% CI 0.01 to 7.00; 103 participants, 1 study; very low‐certainty evidence) and (RR 0.29, CI 0.01 to 7.00; 103 participants, 1 study; very low‐certainty evidence), respectively. We identified no studies that reported on other outcomes for this comparison.
Authors' conclusions
We found a paucity of data that would allow us to reach meaningful conclusions pertaining to the superiority of one form of antiseptic hand hygiene agent over another for the prevention of neonatal infection. Also, the sparse available data were of moderate‐ to very low‐certainty. We are uncertain as to the superiority of one hand hygiene agent over another because this review included very few studies with very serious study limitations.
Background
Breakdown of the developmentally immature epidermal barrier may permit entry for micro‐organisms leading to invasive infection in preterm infants. Topical emollients may improve skin ...integrity and barrier function and thereby prevent invasive infection, a major cause of mortality and morbidity in preterm infants.
Objectives
To assess the effect of topical application of emollients (ointments, creams, or oils) on the risk of invasive infection and mortality in preterm infants.
Search methods
We searched CENTRAL via Cochrane Register of Studies (CRS) Web and MEDLINE via Ovid (updated 08 January 2021) and the reference lists of retrieved articles.
Selection criteria
Randomised or quasi‐randomised controlled trials that assessed the effect of prophylactic application of topical emollient on the risk of invasive infection, mortality, other morbidity, and growth and development in preterm infants.
Data collection and analysis
We used the standard methods of Cochrane Neonatal. Two review authors separately evaluated trial quality, extracted data, and synthesised effect estimates using risk ratio (RR), risk difference (RD), and mean difference. We used the GRADE approach to assess the certainty of evidence for effects on mortality and invasive infection.
Main results
We included 22 trials with a total of 5578 infant participants. The main potential sources of bias were lack of clarity on the methods used to generate random sequences and conceal allocation in half of the trials, and lack of masking of parents, caregivers, clinicians, and investigators in all of the trials.
Eight trials (2086 infants) examined the effect of topical ointments or creams. Most participants were very preterm infants cared for in healthcare facilities in high‐income countries. Meta‐analyses suggested that topical ointments or creams may have little or no effect on invasive infection (RR 1.13, 95% confidence interval (CI) 0.97 to 1.31; low certainty evidence) or mortality (RR 0.94, 95% CI 0.82 to 1.08; low certainty evidence).
Fifteen trials (3492 infants) assessed the effect of topical plant or vegetable oils. Most of these trials were undertaken in low‐ or middle‐income countries and were based in healthcare facilities. One large (2249 infants) community‐based trial occurred in a rural field practice in India. Meta‐analyses suggested that topical oils may reduce invasive infection (RR 0.71, 95% CI 0.52 to 0.96; I² = 52%; low certainty evidence) but have little or no effect on mortality (RR 0.94, 95% CI 0.82 to 1.08, I² = 3%; low certainty evidence).
One trial (316 infants) that compared petroleum‐based ointment versus sunflower seed oil in very preterm infants in Bangladesh showed little or no effect on invasive infection (RR 0.91, 95% CI 0.57 to 1.46; low certainty evidence), but suggested that ointment may lower mortality slightly (RR 0.82, 95% CI 0.68 to 0.98; RD ‐0.12, 95% CI ‐0.23 to ‐0.01; number needed to treat for an additional beneficial outcome 8, 95% CI 4 to 100; low certainty evidence). One trial (64 infants) that assessed the effect of coconut oil versus mineral oil in preterm infants with birth weight 1500 g to 2000 g in India reported no episodes of invasive infection or death in either group (very low certainty evidence).
Authors' conclusions
The level of certainty about the effects of emollient therapy on invasive infection or death in preterm infants is low. Since these interventions are mostly inexpensive, readily accessible, and generally acceptable, further good‐quality randomised controlled trials in healthcare facilities, and in community settings in low‐ or middle‐income countries, may be justified.
Healthcare-associated pathogens, including Staphylococcus capitis, can contaminate incubator surfaces and are of significant concern in neonatal intensive care units (NICUs). Effective incubator ...decontamination is essential for infection prevention and control, with submersion decontamination often recommended. This may not always be achievable, with wipe decontamination seen as an alternative. Here we compare the ability of a two-step (submersion in enzymatic detergent followed by wiping with hypochlorite-based wipes) with a one-step (wiping with quaternary ammonium compound-impregnated wipes) decontamination procedure to remove microbial surrogate markers from neonatal incubator surfaces.
Three cauliflower-mosaic-virus-derived microbial surrogate markers were inoculated on to the fan, a mattress seam and the external arm port door clips of two Giraffe™ Omnibed™ Carestation™ incubators. Incubators were decontaminated either by the one-step or the two-step decontamination process. Swab samples were collected from 28 sites on each incubator and surrounding environment, with marker presence determined by qPCR.
Following two-step decontamination, three of 28 (11%) sample sites were positive for any marker, compared with 12 of 28 (43%) after one-step decontamination. Markers were transferred to several incubator surfaces and recovered from the originally inoculated sites following one-step decontamination, with the marker inoculated on door clips having the greatest transfer. Markers inoculated on to the mattress persisted through both decontamination strategies.
Microbial surrogate markers were not completely removed from incubator surfaces by one-step decontamination alone. Two-step decontamination was the most effective method and removed markers from submergible surfaces, but not from the mattress. These findings indicate that micro-organisms can persist after incubator terminal decontamination, particularly on mattresses and when a two-step decontamination process is not used. This highlights the importance of effective decontamination practices to mitigate micro-organism persistence on incubator surfaces.
Escherichia coli and Klebsiella pneumoniae rank among the primary bacterial culprits in neonatal infections and fatalities in sub-Saharan Africa. This study characterized the phenotypic and genotypic ...features of E coli and K pneumoniae in a labor ward in Yaoundé, Cameroon.
A prospective and cross-sectional study spanning 5months, from February 21, 2022 to June 30, 2022. Rectovaginal swabs were obtained from expectant mothers, and nasopharyngeal swabs were collected from their babies. Hand swabs of health care workers and environmental samples were also collected. The samples were cultured on eosin methylene blue agar. Extended-spectrum ß-lactamase (ESBL) production was assessed using CHROMAgar ESBL and the double-disk synergy test. A polymerase chain reaction was employed to detect ß-lactamase genes.
A total of 93 mothers and 90 neonates were collected. Almost all pregnant women (90%) were colonized by one or more multidrug-resistant (MDR) isolates with 58% being concomitantly ESBL producers. Altogether, 14 of 22 (64%) neonates were colonized by MDR isolates, while out of the 5 workers positive to Enterobacterales, all were colonized by MDR isolates. E coli predominated in pregnant women (55%) and neonates (73%), while K pneumoniae (83%) predominated in health care workers. The blaCTX-M (75%) was the leading ß-lactamase gene detected.
Our study suggests that drug-resistant E coli and K pneumoniae are circulating at high prevalence in the labor ward in Yaoundé and emphasizes the necessity for effective infection prevention and control along with antimicrobial stewardship measures.
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•Escherichia coli and Klebsiella pneumoniae were assessed in a labor ward.•Over 90% of pregnant women and 64% of neonates were colonized by multidrug resistant.•Approximately 70% of neonates were born to ESBL-positive mothers.•The blaCTX-M (75%) was the leading ß-lactamase gene detected.•ERIC fingerprints revealed a likely horizontal transmission of these pathogens.
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