Comparison of efficacy of a 7-day versus a 14-day course of intravenous antibiotics in the treatment of uncomplicated neonatal bacterial sepsis: study protocol of a randomized controlled non-inferiority trial.

BACKGROUND: Neonatal sepsis is a global public health problem. There is no consensus regarding the optimum duration of antibiotics for culture-proven neonatal sepsis. Published randomized controlled trials (RCTs) comparing shorter versus longer courses of antibiotics provide low-quality evidence with serious risk of bias. We hypothesized that among neonates with uncomplicated culture-proven sepsis, antibiotic duration of 7 days is not inferior to 14 days. METHODS: This is a multi-centric, parallel-group, stratified, block-randomized, active-controlled, non-inferiority trial with outcome assessment blinded. Stratification is by center and birth weight. Neonates weighing ≥1000 g at birth, with blood-culture-proven sepsis (barring Staphylococcus aureus and fungi), without conditions warranting > 14 days antibiotics, and who clinically remit, are enrolled in the RCT on day 7 of administration of sensitive antibiotics. They are randomly allocated to no further antibiotics (intervention arm: total 7 days) or 7 more days of the same antibiotics (control arm: total 14 days). Allocation is concealed by opaque, sealed envelopes. The primary outcome is "definite or probable relapse" within 21 days after antibiotic completion. Secondary outcomes include definite and probable relapses at various timepoints until day 35 post-randomization, secondary infections, and adverse events. The neonatologist adjudicating probable relapses and lab personnel are blinded. Three hundred fifty subjects will be recruited in each arm, assuming a non-inferiority margin of 7%, one-sided alpha error 5%, and power of 90%. Analysis will be per protocol and by intention-to-treat. An independent Data Safety Monitoring Board monitors adverse events and will perform one interim analysis when 50% of expected primary outcomes have occurred or 50% of subjects have completed follow-up, whichever is earlier. O'Brien-Fleming criteria will be used to stop for mid-term benefit and Pocock's to stop for mid-term harm. A priori subgroup analyses are planned by birth weight categories, gram-stain status of pathogens, and radiological pneumonia. DISCUSSION: This trial will provide evidence to guide practice regarding optimum duration of antibiotics for culture-proven neonatal bacterial sepsis. If a 7-day regime is proved to be non-inferior to a 14-day regime, it is likely to reduce hospital stay, costs, adverse effects of drugs, and nosocomial infections. TRIAL REGISTRATION: Clinical Trials Registry India CTRI/2017/09/009743 . Registered on 13 September 2017.

Scrub Typhus in a New Born.

Scrub typhus is an acute febrile mite-born rickettsial infection caused by Orientia tsutsugamushi (formely called Rickettsiatsutsugamushi). This infection is very uncommon in neonates. We report a case of 19-day-old newborn presenting with clinical features mimicking severe sepsis but was subsequently diagnosed with primary scrub typhus infection. The timely treatment resulted in dramatic response and complete recovery.

Determining the Effect of External Stressors on Laparoscopic Skills and Performance Between Obstetrics and Gynecology Residents.

STUDY OBJECTIVE: To evaluate the effect of stress on laparoscopic skills between obstetrics and gynecology residents. DESIGN: Observational prospective cohort study. DESIGN CLASSIFICATION: Prospective cohort. SETTING: Urban teaching university hospital. PARTICIPANTS (PATIENTS): Thirty-one obstetrics and gynecology residents, postgraduate years 1 to 4. INTERVENTION: We assessed 4 basic laparoscopic skills at 2 sessions. The first session was the baseline; 6 months later the same skills were assessed under audiovisual stressors. We compared the effect of stress on accuracy and efficiency between the 2 sessions. MEASUREMENTS AND MAIN RESULTS: A linear model was used to analyze time. Under stress, residents were more efficient in 3 of the 4 modules. Ring transfer (hand-eye coordination and bimanual dexterity), p = 0.0304. Ring of fire (bimanual dexterity and measure of depth perception), p = 0.0024 and dissection glove (respect of delicate tissue planes), p = 0.0002. Poisson regression was used to analyze the total number of penalties. Residents were more likely to acquire penalties under stress. Ring transfer, p = 0.0184 and cobra (hand-to-hand coordination), p = 0.0487 yielded a statistically significant increase in penalties in the presence of stressors. Dissection glove p = 0.0605 yielded a nonsignificant increase in penalties. CONCLUSION: Our work confirmed that while under stress residents were more efficient, this translated into their ability to complete tasks faster in all the tested skills. Efficiency, however, came at the expense of accuracy.

Tetanus - still a scourge in the 21st century: a paediatric hospital-based study in India.

Tetanus remains endemic in India. A retrospective hospital-based study was conducted to review the profile of all children admitted with diagnosis of tetanus between January 2009 and December 2010. A total of 140 cases of tetanus were admitted; 45 cases of neonatal tetanus (NT) and 77 cases of post-neonatal tetanus (PNT) were studied. Age of presentation of NT was 9.4 ± 1.2 days. Home-delivered children accounted for 86.7% of cases, with 77.8% being attended by untrained birth attendants. Unimmunized mothers accounted for 93.4%. In PNT, otogenic route of infection and trauma were present in 58.4% and 23.3% of cases, respectively. The rate of hospital admission of tetanus remains high. Unlike previously published reports, otogenic route is the most common mode of PNT infection in this study. Improving immunization, increasing deliveries by skilled birth attendants and prompt treatment of suppurative otitis media are the main areas in which public health initiatives need to be focused.

Human tail: nature's aberration.

Human tail refers to a congenital cutaneous appendix protruding from the lumbosacral region. It is usually associated with an underlying spina bifida occulta, a form of spinal dysraphism. A contiguous fibrolipoma can sometimes be seen extending from the subcutaneous portion of the tail into the inferior spinal cord, resulting in tethered cord syndrome. Management of such lesions includes complete neurologic examination and magnetic resonance imaging. Early diagnosis and microsurgical intervention can prevent development or progression of severe neurologic defects in later life.

Gilbert syndrome increasing unconjugated hyperbilirubinemia in a child with hereditary spherocytosis.

Hemolytic anemia usually gives rise to only a modest elevation of serum bilirubin. Unconjugated hyperbilirubinemia of an extreme degree should raise suspicion of additional factors. We describe a 10-year-old child suffering from hereditary spherocytosis, who had unusually high levels of unconjugated serum bilirubin and was diagnosed to have Gilbert syndrome on the basis of genetic analysis.

Transalar transphenoidal meningoencephalocele: A rare cause of respiratory distress in a neonate.

Respiratory distress in an infant is a common cause of admission in neonatal intensive care facility. Obstructive lesions of the airway constitute a minority of problems in the new born but present a diagnostic challenge. We present a 30-day-old male infant admitted with respiratory distress who was diagnosed to have an oropharyngeal cystic mass which on further evaluation by computed tomography and magnetic resonance imaging revealed a transalar transsphenoidal meningoencephalocele herniating into the oral cavity through a congenital split palate. The patient was operated successfully using a transpalatal approach leading to complete resolution of respiratory distress.