Syndrome Evaluation System (SES) versus Blood Culture (BACTEC) in the Diagnosis and Management of Neonatal Sepsis--A Randomized Controlled Trial.

OBJECTIVE: To compare the clinical outcome of a multiplex polymerase chain reaction (PCR) based molecular diagnostic method -- Syndrome Evaluation System (SES) directed treatment strategy vs. standard of care (blood culture) directed treatment strategy for neonatal sepsis. METHODS: This randomized controlled trial (RCT) included 385 neonates with sepsis who were randomized into two groups -- SES and control (BACTEC). Both tests were performed for all the neonates. However, in the SES group, the results of SES test were revealed to the treating clinicians, while in the control group, SES results were withheld. Two ml of blood was drawn from each baby. One aliquot was sent for blood culture, whereas the remaining aliquot was sent for SES. Babies were then administered empirical IV antibiotics and given supportive care. Further antibiotic changes, if required were done in SES and control groups based on their respective reports. The microbiological profile, immediate outcome, duration of hospital stay, number of antibiotics used and readmission within a month in both groups were compared. RESULTS: SES was better than BACTEC in identifying the causative organism in both the groups (68 % vs. 18 % in SES group and 72 % vs. 18 % in control group). SES had 100 % concordance with blood culture by BACTEC. Detection of bacteria and fungi were four and ten-fold higher respectively with SES when compared to BACTEC culture. Microbiological diagnosis was rapid with SES compared to BACTEC (7 h vs. 72 h). Treatment based on SES resulted in significantly less mortality (3 % vs. 18 %). Readmission rate, duration of hospital stay and change in antibiotics were also significantly less in SES group. CONCLUSIONS: This new molecular based diagnostic system (SES) helps in rapid and accurate diagnosis of neonatal sepsis and reduces mortality and morbidity in affected neonates.

Early versus late enteral prophylactic iron supplementation in preterm very low birth weight infants: a randomised controlled trial.

OBJECTIVES: To evaluate whether preterm very low birth weight (VLBW) infants receiving early iron (EI) supplementation (2 mg/kg/day elemental iron) at 2 weeks postnatal age have improved serum ferritin levels compared with late iron (LI) supplementation at 6 weeks postnatal age. DESIGN: Single-blinded parallel-group interventional randomised controlled trial. SETTING: Tertiary care centre in southern India. INTERVENTIONS: Randomised at 2 weeks postnatal age to EI and LI groups and evaluated at 2, 6 and 12 weeks postnatal age. OUTCOME: The primary outcome was serum ferritin level at 12 weeks, and the secondary outcomes were the incidence of neonatal morbidities, haemoglobin level, anthropometric parameters and blood transfusion requirements. RESULTS: Of the 104 babies randomised, outcomes were analysed in 46 and 47 babies in EI and LI groups, respectively. Serum ferritin level was significantly higher (p<0.001) at 12 weeks (82±5 vs 63±3 ng/mL) in the EI group. Haemoglobin (10.1±0.4 vs 9.2±0.4 g/dL) and mean corpuscular haemoglobin concentration (31±0.5 vs 29.4±0.5 g/dL) were also significantly (p<0.001) higher at 12 weeks in the EI group. There was a significant decrease of ferritin in the LI group and significant increase in ferritin in the EI group at 6 weeks compared with 2 weeks. There were no significant differences in the incidences of neonatal morbidities (necrotising enterocolitis, periventricular leukomalacia, retinopathy of prematurity), anthropometric parameters and blood transfusion requirements between the two groups. CONCLUSIONS: EI supplementation in preterm VLBW infants improves serum ferritin and haemoglobin levels. TRIAL REGISTRATION: CTRI/2013/01/003277.

Neural tube defects in Pondicherry.

OBJECTIVE: This study was carried out to identify the trend and the frequency of neural tube defects from July 1998 to June 2004. METHODS: A total of 310 babies were born with neural tube defects with the overall frequency of 5.7/1000 births compared to 2.3/1000 births observed earlier in our hospital. RESULTS: The most common defect was spina bifida (54.8%) followed by anencephaly (31.6%), and encephalocele (11.6%). More neural tube defects were observed in female and low birth weight babies, still births and unbooked mothers. Neural tube defect was significantly higher among babies born to parents of consanguineous marriage (p< 0.01). Associated congenital defects were observed in thirty nine (12.6%) cases. CONCLUSION: The rise in the frequency of NTDS may indicate the current trend of NTDs in Southern India. A further prospective study is desired to measure the effectiveness of regular folic acid supplementation in bringing down this frequency.