Three Different Regimens for Vitamin K Birth Prophylaxis in Infants Born Preterm: A Randomized Clinical Trial.

OBJECTIVE: To study the efficacy of 3 different vitamin K birth prophylaxis regimens in infants born premature. STUDY DESIGN: This was an open-label, parallel-group, randomized clinical trial conducted in a tertiary neonatal care unit in India. Infants born very preterm (≤32 weeks) and/or with very low birth weight (≤1500 g) were included. In each arm, 25 babies were enrolled. Babies were randomized to receive 1.0 mg, 0.5 mg, or 0.3 mg intramuscular (IM) vitamin K1 at birth. Protein induced by vitamin K absence - II (PIVKA-II) levels were assessed at birth, and on days 5 and 28, along with the frequency of death, bleeding manifestations, intraventricular hemorrhage, necrotizing enterocolitis, bilirubin levels, and duration of phototherapy. The primary outcome was comparison of PIVKA-II levels on day 5 of life. RESULTS: All the 3 regimens resulted in similar proportion of vitamin K subclinical sufficiency (PIVKA-II < 0.028 AU/mL) infants on day 5 (1 mg - 100%; 0.5 mg - 91.7%; 0.3 mg - 91.7%, P = .347), with no significant difference in median (IQR) PIVKA-II levels (AU/mL): 1 mg 0.006 (0.004, 0.009); 0.5 mg 0.008 (0.004, 0.009); 0.3 mg 0.006 (0.003, 0.009), P = .301. However, on day 28, there was a significant decrease in the proportion of vitamin K-sufficient infants in the 0.3-mg IM group (72.7%) compared with the 1.0-mg (100%) or 0.5-mg (91.3) groups. The 1.0-mg group had significantly greater bilirubin levels and duration of phototherapy. None of the other clinical outcomes were statistically different. CONCLUSIONS: Both 1-mg and 0.5-mg IM vitamin K birth prophylaxis resulted in high sufficiency on follow-up, compared with 0.3 mg. The current recommendation of 0.5-1 mg IM vitamin K birth prophylaxis for infants born preterm, needs to be continued. TRIAL REGISTRATION: CTRI/2022/02/040396.

Comparison of efficacy, safety & satisfaction of intermittent versus continuous phototherapy in hyperbilirubinaemic newborns ≥35 week gestation: A randomized controlled trial.

BACKGROUND & OBJECTIVES: Phototherapy (PT) has become the standard of care for treating neonatal jaundice. This study was aimed to find out if intermittent PT (IPT) results in comparable rate of fall of bilirubin level to continuous PT (CPT) and results in lesser side effects and better acceptance. METHODS: In this non-inferiority trial, 174 neonates ≥35 wk gestation and >2000 g with jaundice requiring PT were randomized to receive either IPT (one hour on and two hours off) or CPT (with minimum interruptions for feeding) after device stratification [light-emitting diode (LED) or compact fluorescent light (CFL)]. Bilirubin was checked 12th hourly, and calcium, vitamin D and nitric oxide (NO) levels were analyzed along with the clinical side effects and nursing and maternal satisfaction scores (CTRI Registration No. CTRI/2018/01/011072). RESULTS: The rate of fall of bilirubin was similar in both the CPT and IPT groups [0.16 (0.10, 0.22) vs. 0.13 (0.09, 0.20) mg/dl/h, P=0.22]. The median difference with 95 per cent confidence interval of 0.03 (0.03, 0.03) mg/dl was also within the pre-defined inferiority limits. There was no significant change in the duration of PT and side effects such as fall in calcium levels, rise in vitamin D and NO levels or the clinical side effects. Maternal satisfaction favoured the IPT group, but the nurses opined that IPT was difficult to implement. Subgroup analysis for PT devices used showed that efficacy of both CFL and LED devices was equivalent. INTERPRETATION & CONCLUSIONS: IPT was non-inferior to CPT in reducing bilirubin levels in ≥35 wk neonates, irrespective of device used, and also mothers reported better satisfaction with IPT. Although IPT appears promising, CPT does not increase clinical and biochemical side effects compared to IPT.

Diagnostic Reliability of Salivary C-Reactive Protein as an Alternative Noninvasive Biomarker of Neonatal Sepsis.

OBJECTIVE: To assess if salivary C-reactive protein (CRP) can be detected in neonatal sepsis and correlate the levels of salivary and serum CRP. METHODS: This analytical cross-sectional study included all neonates £28 days of life with suspected sepsis or with perinatal risk factors for sepsis. Saliva was collected using an absorbent swab and analyzed by enzyme-linked immunosorbent assay, along with serum CRP. RESULTS: Salivary CRP was detectable in 135 subjects (99%). An increase was seen in median (IQR) levels from 0.25 (0.13,0.3) ng/mL in clinical sepsis group to 0.6 (0.3,1.4) ng/mL in screen positive/blood culture negative group, and to 1.98 (0.54, 2.95) ng/mL in blood culture positive group. There was a moderate positive correlation between salivary and serum CRP (r=0.63, P value 0.01). On receiver-operator characteristics curve, the area under the curve of salivary CRP for predicting serum CRP ≥10 mg/L was 0.861 (95% CI, 0.78 to 0.94; P <0.001), with the optimal salivary CRP cut-off being 0.6 ng/mL. CONCLUSION: Salivary CRP could be used as an alternative biomarker of neonatal sepsis.

Holocord abscess in association with congenital dermal sinus.

Intramedullary spinal cord abscess in children is rare and holocord abscess is rarer. An 18-month-old girl presented with rapidly progressive paraplegia with fever for 2 months. The patient had complete flaccid paraplegia with absent sensation below D4 level. There was very small dermal sinus discharging pus in the lower lumbar region. Magnetic resonance imaging showed evidence of extensive multiloculated intramedullary abscess extending from D4 to L5 with cord edema upto cervical level. Laminotomy, excision of the dermal sinus and myelotomy, and evacuation of intramedullary abscess was performed. Escherichia coli and Pseudomonas were grown on culture. The child was treated with long-term parenteral antibiotics and started showing neurological improvement. Holocord abscess secondary to congenital dermal sinus is extremely rare and this is only the fourth report of such an instance.