scholarly journals Routine Early Antibiotic use in SymptOmatic preterm Neonates (REASON): a prospective randomized controlled trial

2020 ◽  
Author(s):  
J. Lauren Ruoss ◽  
Catalina Bazacliu ◽  
Jordan T. Russell ◽  
Diomel de la Cruz ◽  
Nan Li ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Trial ◽  
Premature Infants ◽  
Neonatal Intensive Care ◽  
Late Onset ◽  
Controlled Trial ◽  
Antibiotic Use ◽  
Preterm Neonates ◽  
Serious Adverse Events ◽  
Late Onset Sepsis

AbstractObjectiveWe aim to assess the feasibility of a pragmatic randomized trial of antibiotics vs. no antibiotics in symptomatic premature infants after birth. Most premature infants are exposed to antibiotics after birth without evidence of benefit or harm for this practice. No study to date has attempted to randomize premature infants to antibiotics vs no antibiotics after birth.Study DesignInfants <33 weeks’ gestation admitted to the University of Florida Neonatal Intensive Care Unit were assigned to one of three groups after birth: (A) high risk – antibiotics indicated (B) low risk – antibiotics not indicated (C) eligible for un-blinded randomization (no antibiotics vs antibiotics). The primary outcome is a composite of serious adverse events including (necrotizing enterocolitis, late onset sepsis, bronchopulmonary dysplasia, and death). Odds ratios (and 95% CI’s) were calculated to compare adverse event rates between the two randomized groups.Results186 subjects were enrolled (98 infants and 88 mothers) were enrolled over a 2-year period. 56% of infants (n=55) were randomized; 48% of infants randomized to the no antibiotics arm were switched and received antibiotics within the first 48 hours after birth. Serious adverse events were not significantly different between the randomization arms.ConclusionThis is the first prospective randomized trial of antibiotics vs no antibiotics after birth in symptomatic premature infants. The results of this trial establish a framework of feasibility for a larger multicentered trial that is needed to evaluate the risks and benefits of routine antibiotic exposure in premature infants.

Effect of lactoferrin in the prevention of late-onset sepsis in preterm neonates: a randomized-controlled trial

2021 ◽  
Vol 34 (1) ◽  
pp. 1
Author(s):  
MarwaM Farag ◽  
OmneyaM.K.B Eldin ◽  
MennattAllahH Attia ◽  
NadaI.A Morsi ◽  
RaniaM.A.S El haddad
Keyword(s):  
Randomized Controlled Trial ◽  
Late Onset ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Randomized Controlled ◽  
Late Onset Sepsis

scholarly journals Safety of meningococcal group B vaccination in hospitalised premature infants

2018 ◽  
Vol 104 (2) ◽  
pp. F171-F175 ◽  
Author(s):  
Alison Kent ◽  
Kazim Beebeejaun ◽  
Serena Braccio ◽  
Seilesh Kadambari ◽  
Paul Clarke ◽  
...  
Keyword(s):  
Adverse Events ◽  
Premature Infants ◽  
Antibiotic Use ◽  
Neurological Status ◽  
Serious Adverse Events ◽  
Historical Cohort ◽  
Protein Levels ◽  
Reactive Protein ◽  
Before And After ◽  
Group B

ObjectivesTo assess the risk of significant adverse events in premature infants receiving the novel 4-component group B meningococcal vaccine (4CMenB) with their routine immunisations at 2 months of age.Participants, design and settingIn December 2015, Public Health England requested neonatal units across England to voluntarily participate in a national audit; 19 units agreed to participate. Anonymised questionnaires were completed for infants receiving 4CMenB alongside their routine immunisations. For comparison, a historical cohort of premature infants receiving their primary immunisations without 4CMenB or paracetamol prophylaxis was used.Main outcome measuresParacetamol use; temperature, cardiovascular, respiratory and neurological status before and after vaccination; and management and investigations postvaccination, including serum C reactive protein levels, infection screens and antibiotic use.ResultsComplete questionnaires were returned for 133 premature infants (<35 weeks’ gestation) who received their first dose of 4CMenB at 8 weeks of age, including 108 who received prophylactic paracetamol according to national recommendations. Overall, 7% (8/108) of infants receiving 4CMenB with paracetamol had fever (>38°C) after vaccination compared with 20% (5/25) of those receiving 4CMenB without paracetamol (P=0.06) and none of those in the historical cohort. There were no significant differences between cohorts in the proportion of infants with apnoea, bradycardia, desaturation and receiving respiratory support after vaccination.Conclusions4CMenB does not increase the risk of serious adverse events in hospitalised premature infants. This audit supports the current national recommendations to offer 4CMenB with other routine vaccinations and prophylactic paracetamol to premature infants at their chronological age.

scholarly journals QUALITATIVE REVIEW OF ANTIBIOTIC USE FOR NEONATAL SEPSIS

2018 ◽  
Vol 10 (1) ◽  
pp. 364
Author(s):  
Tjio Ie Wei ◽  
Purwantyastuti Ascobat ◽  
Rinawati Rohsiswatmo ◽  
Insti Instiaty
Keyword(s):  
Neonatal Sepsis ◽  
Neonatal Intensive Care ◽  
Late Onset ◽  
Antibiotic Use ◽  
Klebsiella Pneumonia ◽  
First Line ◽  
Normal Birth ◽  
Late Onset Sepsis ◽  
Sensitivity Tests ◽  
Blood Specimens

Objective: The aim of this study is to evaluate the antibiotic use in neonates with sepsis.Methods: An observational retrospective study was conducted using medical records of neonates diagnosed with early-/late-onset sepsis who wereprescribed antibiotics and who were treated in the neonatal intensive care unit (NICU) at the Dr. Cipto Mangunkusumo Hospital between January 1 andDecember 31, 2015. Patient records were screened for antibiotic use; qualitative analyses were performed using the Gyssens algorithm. Concordanceof empirical antibiotic prescriptions with subsequent blood culture and sensitivity tests was evaluated.Results: A total of 176 sepsis cases included 80 and 96 neonates with normal and low birth weights (LBWs), respectively. Ampicillinsulbactam+gentamycin, which is indicated in local guidelines as the first-line antibiotic combination for neonatal sepsis, was most frequentlyprescribed. In the normal birth weight group, appropriate antibiotic use (Gyssens Category I) was found in 89.7% of cases, whereas Gyssens Category V(no indication) was found in 4.54% of cases. In the LBW group, 88.1% and 6.2% of cases were included in Gyssens Categories I and V, respectively.Only 17.5% and 13.5% cultured blood specimens from normal and LBW groups, respectively, yielded positive results; the most commonly identifiedbacteria were Acinetobacter baumannii and Klebsiella pneumonia. All isolates were resistant to ampicillin-sulbactam; only 7.4% were sensitive togentamicin.Conclusion: Antibiotic use for neonatal sepsis in NICU in this study can be considered appropriate, suggesting proper implementation of antimicrobialguidelines. However, high rates of resistance to the first-line antibiotics for neonatal sepsis are concerning.

A multicenter, randomized trial on prophylactic bovine lactoferrin in preterm neonates for prevention of late-onset sepsis

2008 ◽  
Vol 84 ◽  
pp. S7-S8 ◽  
Author(s):  
Paolo Manzoni ◽  
Stolfi Ilaria ◽  
Hubert Messner ◽  
Rosario Magaldi ◽  
Silvia Cattani ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Late Onset ◽  
Preterm Neonates ◽  
Bovine Lactoferrin ◽  
Multicenter Randomized Trial ◽  
Late Onset Sepsis

scholarly journals Trajectories of the heart rate characteristics index, a physiomarker of sepsis in premature infants, predict Neonatal ICU mortality

2020 ◽  
Vol 9 ◽  
pp. 204800402094514
Author(s):  
Amanda M Zimmet ◽  
Brynne A Sullivan ◽  
J Randall Moorman ◽  
Douglas E Lake ◽  
Sarah J Ratcliffe
Keyword(s):  
Heart Rate ◽  
Premature Infants ◽  
Neonatal Intensive Care ◽  
Time Course ◽  
Very Low Birth Weight ◽  
Late Onset ◽  
Low Birth Weight Infants ◽  
Late Onset Sepsis ◽  
Neonatal Icu ◽  
Time Courses

Objective Trajectories of physiomarkers over time can be useful to define phenotypes of disease progression and as predictors of clinical outcomes. The aim of this study was to identify phenotypes of the time course of late-onset sepsis in premature infants in Neonatal Intensive Care Units. Methods We examined the trajectories of a validated continuous physiomarker, abnormal heart rate characteristics, using functional data analysis and clustering techniques. Participants We analyzed continuous heart rate characteristics data from 2989 very low birth weight infants (<1500 grams) from nine NICUs from 2004–2010. Result Despite the relative homogeneity of the patients, we found extreme variability in the physiomarker trajectories. We identified phenotypes that were indicative of seven and 30 day mortality beyond that predicted by individual heart rate characteristics values or baseline demographic information. Conclusion Time courses of a heart rate characteristics physiomarker reveal snapshots of illness patterns, some of which were more deadly than others.

scholarly journals Incidence of necrotising enterocolitis before and after introducing routine prophylactic Lactobacillus and Bifidobacterium probiotics

2019 ◽  
Vol 105 (4) ◽  
pp. 380-386 ◽  
Author(s):  
Claire Robertson ◽  
George M Savva ◽  
Raducu Clapuci ◽  
Jacqueline Jones ◽  
Hassan Maimouni ◽  
...  
Keyword(s):  
High Risk ◽  
Neonatal Intensive Care ◽  
Late Onset ◽  
Hazard Ratio ◽  
Necrotising Enterocolitis ◽  
University Hospital ◽  
Preterm Neonates ◽  
Feeding Rates ◽  
Late Onset Sepsis ◽  
Before And After

ObjectiveTo compare rates of necrotising enterocolitis (NEC), late-onset sepsis, and mortality in 5-year epochs before and after implementation of routine daily multistrain probiotics administration in high-risk neonates.DesignSingle-centre retrospective observational study over the 10-year period from 1 January 2008 to 31 December 2017.SettingLevel 3 neonatal intensive care unit (NICU) of the Norfolk and Norwich University Hospital, UK.PatientsPreterm neonates at high risk of NEC: admitted to NICU within 3 days of birth at <32 weeks’ gestation or at 32–36 weeks’ gestation and of birth weight <1500 g.InterventionPrior to 1 January 2013 probiotics were not used. Thereafter, dual-species Lactobacillus acidophilus and Bifidobacterium bifidum combination probiotics were routinely administered daily to high-risk neonates; from April 2016 triple-species probiotics (L. acidophilus, B. bifidum, and B. longum subspecies infantis) were used.Main outcome measuresIncidence of NEC (modified Bell’s stage 2a or greater), late-onset sepsis, and mortality.ResultsRates of NEC fell from 7.5% (35/469 neonates) in the pre-implementation epoch to 3.1% (16/513 neonates) in the routine probiotics epoch (adjusted sub-hazard ratio=0.44, 95% CI 0.23 to 0.85, p=0.014). The more than halving of NEC rates after probiotics introduction was independent of any measured covariates, including breast milk feeding rates. Cases of late-onset sepsis fell from 106/469 (22.6%) to 59/513 (11.5%) (p<0.0001), and there was no episode of sepsis due to Lactobacillus or Bifidobacterium. All-cause mortality also fell in the routine probiotics epoch, from 67/469 (14.3%) to 47/513 (9.2%), although this was not statistically significant after multivariable adjustment (adjusted sub-hazard ratio=0.74, 95% CI 0.49 to 1.12, p=0.155).ConclusionsAdministration of multispecies Lactobacillus and Bifidobacterium probiotics has been associated with a significantly decreased risk of NEC and late-onset sepsis in our neonatal unit, and no safety issues. Our data are consistent with routine use of Lactobacillus and Bifidobacterium combination probiotics having a beneficial effect on NEC prevention in very preterm neonates.

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