Randomized controlled trial of 7-Day vs. 14-Day antibiotics for neonatal sepsis

There are no evidence-based guidelines available regarding the duration of antibiotics in neonatal septicemia. We compared the effectiveness of a 7-day intravenous antibiotic regimen with the standard 14-day regime in blood-culture-proven sepsis in neonates. This was a controlled, blinded, randomized trial with stratification (for birth weight). Blood-culture-positive septic babies > or =32 weeks and/or > or =1500 g were enrolled if meningitis and other deep-seated focal infections were ruled out. Parental consent was obtained. Randomization to either 7-day or 14-day therapy was done on day 7 of antibiotics if the baby had clinically remitted by day 5. Blood culture was repeated 24 h after antibiotic completion. Subjects were observed in the hospital for at least 72 h, and followed-up for 28 days by weekly visits and telephonic contacts. The primary outcome was treatment failure within 28 days defined as a positive blood culture, or clinical signs accompanied by either positive CRP or adjudicated to be a relapse by an expert committee. A total of 120 babies were eligible, 51 were excluded (no consent: 12; non-remission: 39), and 69 were randomized to receive either a 7-day course (n = 34) or a 14-day course (n = 35) of antibiotics. Baselines variables were comparable in the two groups. Primary outcome assessment could be done in 33 cases in either group. There was a trend to greater treatment failures in the 7-day group compared with 14-day group (5 vs. 1, respectively; P = 0.19). On subgroup analysis of subjects with Staphylococcus aureus infection, those who received 7-day therapy (n = 7) had significantly more treatment failure than 14-day therapy (n = 7) (four and zero, respectively; P = 0.022), whereas on sub-group analysis of babies with non-S. aureus infections, treatment failure rates were identical (3.8% in both groups). On comparing the organisms isolated in the group of subjects which was not randomized by virtue of being symptomatic (n = 39) vs. the group which was randomized (n = 69), it was found that S. aureus infections were significantly commoner in the former group (61.5 vs. 21.3%, respectively; P < 0.001). Neonates > or =32 weeks and/or > or =1500 g with S. aureus sepsis require 14 days of antibiotics. S. aureus infection is also associated with failure to achieve clinical remission by the 5th day of antibiotic therapy. Larger trials are required to confirm whether neonates with non-S. aureus sepsis, whose symptoms remit by 5 days, can be treated with 7 days of antibiotics.     

Exchange transfusions in neonatal sepsis

Between October, 1987 and October, 1988, 53 neonates with severe or unresponsive sepsis were subjected to therapeutic exchange transfusions (ET) using 170 ml/kg of citrated blood less than 24 hours old. The procedure was repeated up to a maximum of 4 times. The success of therapy was adjudged by resolution of sclerema and/or improvement in clinical features. There were 32 low birth-weight (LBW) and 21 non-LBW infants and 51/53 subjects had sclerema. The mean time for recovery following ET was 19.6 +/- 12.4 h (range: 1-48 h). The overall survival was 77.4% and the survival rates for LBW and non-LBW infants were 73.6 and 68.2%, respectively, however, the difference was not statistically significant. No significant or fatal complications occurred during ET. The effects of other associated problems on outcome studied by multiple regression analysis showed that neurologic problems were associated with a poor chance for survival despite ET. Exchange transfusion may thus be an effective and safe therapeutic modality for severe neonatal sepsis.     

Comet assay in neonatal sepsis

Objective  

To determine whether the DNA damage detected using the Comet assay helps in the diagnosis of neonatal sepsis     

Early onset neonatal sepsis

Objective: To study the maternal risk factors and clinico-bacteriological profile of early onset sepsis (EOS), in a tertiary care neonatal unit.Methods: Relevant data of neonates born during the study period were obtained from their case records. A diagnosis of early onset sepsis was made if either clinical sepsis developed within 72 hours of life or if positive blood/CSF cultures were obtained in those with potential maternal risk factors. Statistical analysis was done using Odds Ratio or Chisquare and Fisher’s exact t-test as applicable.Results: Among 1743 live births, a total of 69 episodes of sepsis occurred in 65 neonates (43% culture proven) with an incidence of 37.2 per 1000 live births. The incidence of EOS was 20.7 per 1000 live births and it constituted 55.4% of overall sepsis. Among the perinatal risk factors assessed, a significant association of EOS with prolonged rupture of membranes, foul smelling liquor, dai (midwife) handling and maternal urinary tract infection was observed (p<0.05). Among infants at risk of EOS, 20.6% developed sepsis compared to only 0.5% of those without these risk factors (p 0.001). Even among those at high risk such as low birth weight, preterm, and asphyxiated neonates, incidence of EOS was negligible in the absence of a maternal risk factor. Pneumonia (66.7%), shock (27.7%), metabolic acidosis (19.4%) and meningitis (8.3%) were the comorbidities seen among the cases. Culture proven EOS occurred in 41.6%,Pseudomonas being the commonest (60%) isolate. The case fatality rate was 19.4%.Conclusion: Screening for sepsis in an asymptomatic neonate is warranted only in the presence of a maternal risk factor even if the neonate is at high risk of developing sepsis due to associated problems of prematurity, low birth weight or asphyxia. Knowledge of likely causative organisms of EOS can aid in instituting prompt and appropriate therapy, in order to minimise morbidity and mortality.