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.

Evaluating the efficacy of a multistrain probiotic supplementation for prevention of neonatal sepsis in 0-2-month-old low birth weight infants in India-the "ProSPoNS" Study protocol for a phase III, multicentric, randomized, double-blind, placebo-controlled trial.

BACKGROUND: Progress has been made in the reduction of under-five mortality in India; however, neonatal mortality is reducing at a slower rate. Efforts are required to bring down neonatal mortality in order to attain the Sustainable Development Goal-3. Prevention of sepsis among the high-risk, vulnerable low birth weight neonates by a newer intervention with probiotic supplementation is promising. METHODS: A phase III, multicenter, randomized, double-blind, placebo-controlled study is being conducted at six sites in India. A total of 6144 healthy low birth weight (LBW) infants fulfilling the eligibility criteria would be enrolled within the first week of life, after obtaining written informed consent from the parents of the infant. Randomization in 1:1 ratio, stratified by site, sex, and birth weight, would be done through an interactive web response system (IWRS) using a standard web browser and email service. Vivomixx®, a probiotic containing a mix of 8 strains of bacteria, in a suspension form standardized to deliver 10 billion CFU/ml, or an organoleptically similar placebo would be fed to enrolled infants in a 1-ml/day dose for 30 days. The follow-up of enrolled infants for 60 days would take place as per a pre-specified schedule for recording morbidities and outcome assessments at the six participating sites. Screening for morbidities would be conducted by trained field workers in the community, and sick infants would be referred to designated clinics/hospitals. A physician would examine the referred infants presenting with complaints and clinical signs, and blood samples would be collected from sick infants for diagnosis of neonatal sepsis by performing sepsis screen and blood culture. Appropriate treatment would be provided as per hospital protocol. The study would be implemented as per the MRC guideline for the management of Global Health Trials in accordance with ICH-GCP and Indian Regulatory guidelines. A contract research organization would be engaged for comprehensive monitoring and quality assurance. The final analysis would be conducted in a blinded manner as per the statistical analysis plan (SAP) to estimate the primary outcomes of sepsis, possible serious bacterial infection (PSBI), and secondary outcomes. The codes will be broken after DMC permission. The protocol has been reviewed by the Research Ethics Committee of the Liverpool School of Tropical Medicine (REC-LSTM), from Research Ethics Committees of the six subject recruitment participating sites. DISCUSSION: This adequately powered and well-designed trial would conclusively answer the question whether probiotics can prevent neonatal sepsis in the high-risk group of low birth weight infants as indicated by a pilot study in 1340 LBW infants, evidence from systematic reviews of hospital-based studies, and a primary study on healthy newborns in Orissa. Results of the study would be generalizable to India and other low-middle-income countries. TRIAL REGISTRATION: Clinical Trial Registry of India (CTRI) CTRI/2019/05/019197 . Registered on 16 May 2019.

Goat lung surfactant for treatment of respiratory distress syndrome among preterm neonates: a multi-site randomized non-inferiority trial.

OBJECTIVE: To investigate the safety and efficacy of goat lung surfactant extract (GLSE) compared with bovine surfactant extract (beractant; Survanta®, AbbVie, USA) for the treatment of neonatal respiratory distress syndrome (RDS). STUDY DESIGN: We conducted a double-blind, non-inferiority, randomized trial in seven Indian centers between June 22, 2016 and January 11, 2018. Preterm neonates of 26 to 32 weeks gestation with clinical diagnosis of RDS were randomized to receive either GLSE or beractant. Repeat dose, if required, was open-label beractant in both the groups. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age (PMA). Interim analyses were done by an independent data and safety monitoring board (DSMB). RESULT: After the first interim analyses on 5% enrolment, the "need for repeat dose(s) of surfactant" was added as an additional primary outcome and enrolment restricted to intramural births at five of the seven participating centers. Following second interim analysis after 98 (10% of 900 planned) neonates were enroled, DSMB recommended closure of study in view of inferior efficacy of GLSE in comparison to beractant. There was no significant difference in the primary outcome of death or BPD between GLSE group (n = 52) and beractant group (n = 46) (50.0 vs. 39.1%; OR 1.5; 95% CI 0.7-3.5; p = 0.28). The need for repeat dose of surfactant was significantly higher in GLSE group (65.4 vs. 17.4%; OR 9.0; 95% CI 3.5-23.3; p < 0.001). CONCLUSIONS: Goat lung surfactant was less efficacious than beractant (Survanta®) for treatment of RDS in preterm infants. Reasons to ascertain inferior efficacy of goat lung surfactant requires investigation and possible mitigating strategies in order to develop a low-cost and effective surfactant.

Short Term Neurobehavioral Outcomes in Late Preterm Neonates Born to Pre-Eclamptic Mothers.

OBJECTIVE: To study the effect of maternal pre-eclampsia on the short-term neurobehavioral outcomes in late preterm neonates using Neurobehavioral Assessment of Preterm Infants (NAPI) score. METHODS: 30 late preterm neonates born to mothers with preeclampsia, and thirty controls born to mothers without pre-eclampsia were enrolled, and followed up to 40 weeks of post-menstrual age. They were evaluated by NAPI score of MDV (Motor development-vigor) and AO (Alertness orientation) at 40 wk. RESULTS: The mean NAPI score of MDV in cases was 60.1 (9.56) as compared to 70.0 (11.48) in controls (P <0.001). The mean NAPI score of AO in cases was 37.45 (11.04) as compared to 45.6 (13.33) in controls (P=0.006). CONCLUSION: Late preterm neonates born to mothers with pre-eclampsia have poor short term neurobehavioral outcomes.

Early Total Enteral Feeding versus Conventional Enteral Feeding in Stable Very-Low-Birth-Weight Infants: A Randomised Controlled Trial.

OBJECTIVE: To evaluate the effect of early total enteral feeding (ETEF) when compared with conventional enteral feeding (CEF) in stable very-low-birth-weight (VLBW; 1,000-1,499 g) infants on the postnatal age (in days) at attaining full enteral feeds. METHODS: In this unblinded randomised controlled trial, 180 infants were allocated to an ETEF (n = 91) or a CEF group (n = 89). Feeds were initiated as total enteral feeds in the ETEF group and as minimal enteral nutrition (20 mL/kg) in the CEF group. The rest of the day's requirement in the CEF group was provided as parenteral fluids. The primary outcome was postnatal age at attaining full enteral feeds. The secondary outcomes included episodes of feed intolerance, incidence of sepsis and necrotising enterocolitis (NEC), and duration of hospital stay. RESULTS: The baseline variables including birth weight and gestational age were similar in the two groups. The infants of the ETEF group attained full enteral feeds earlier than those of the CEF group (6.5 ± 1.5 vs. 10.1 ± 4.1 days postnatal age; mean difference -3.6 [-4.5 to -2.7]; p < 0.001). Total episodes of feed intolerance and clinical sepsis were fewer, with a shorter duration of hospital stay, in the ETEF group (15.5 vs. 19.6 days) (p = 0.01). The incidence of NEC was similar in the two groups. CONCLUSION: ETEF in stable VLBW infants results in earlier attainment of full feeds and decreases the duration of hospital stay without any increased risk of feed intolerance or NEC.

Surfactant Lung Lavage vs. Standard Care in the Treatment of Meconium Aspiration Syndrome-A Randomized Trial.

OBJECTIVE: The objective of this study was to evaluate the effect of surfactant lung lavage (SLL) on duration of respiratory support in neonates with meconium aspiration syndrome (MAS). PATIENTS AND METHODS: Sixty term infants with MAS who had moderate to severe respiratory distress (Downes score >4) were randomized toSLL (n = 31) or no lung lavage-NLL (n = 29). Neonates in intervention group underwent lung lavage with dilute surfactant and those in control group were managed as per unit protocol. RESULTS: The median duration of respiratory support was 34 h in SLL group and 44 h in NLL group (p value = 0.994). The duration of oxygen therapy post-respiratory support decreased by 78% in SLL as compared with NLL group (4 vs. 18 h) (p value = 0.005). Lavage procedure was well tolerated with fall in mean heart rate by just 20/min and in mean saturation drop by just 6% during the procedure. CONCLUSION: Lung lavage is well tolerated by neonates, but it does not alter overall duration of respiratory support.

Prenatal Yoga: Effects on Alleviation of Labor Pain and Birth Outcomes.

Background: This study was conducted to test the hypothesis that prenatal yogic exercises are effective in alleviating labor pain and improving birth outcomes, by comparing pregnant women undertaking yoga with a control group. Trial design: Single blinded, parallel randomized control trial. Methods: Two hundred primigravid women of 30 weeks of gestation onward who met the inclusion criteria (primigravida, 20-35 years of age, gestational age of 30 weeks, no prior experience of yoga) were randomly assigned to study (n = 100) and control groups (n = 100) by using the minimized randomization program version 2.01. The study group received the intervention in the form of integrated yoga consisting of a series of 30-min practice sessions at the 30th, 32nd, 34th, 36th, 37th, 38th, and 39th weeks of gestational age. The matched control group did not perform yoga. The patients were followed till delivery for maternal comfort, alleviation of labor pain, and birth outcome. Alleviation of labor pain was assessed by using numerical pain intensity scale (NPIS), pain behavioral observational scale (PBOS), and maternal delivery comfort questionnaire. Only the assessors were blinded. Results: Two hundred patients were randomized into 100 each in case and control groups. Final analysis was done on 75 patients in each group after exclusion due to development of complications, loss to follow-up. The requirement of induction of labor and analgesics was significantly less in the study group (p < 0.044, p < 0.045). There was significantly more number of normal vaginal deliveries (p < 0.037) and less caesarean sections (p < 0.048), shorter first stage of labor (p < 0.0003) in the study group practicing yoga. The tolerance of pain was better in the study group as shown by NPIS (p < 0.001) and PBOS scores (p < 0.0001). Postpartum, the maternal comfort questionnaire score showed higher comfort in the study group (p < 0.032). The number of low birth weight babies was also significantly less in the study group (p < 0.042). There were no adverse effects attributed to yoga. Conclusion: The study has highlighted that yoga is a noninvasive, easy to learn mind-body medicine and complementary health practice, effective in alleviation of labor pain and possibly improving birth outcome.

Yield of meconium in non-vigorous neonates undergoing endotracheal suctioning and profile of all neonates born through meconium-stained amniotic fluid: a prospective observational study.

BACKGROUND: Delivery room management of infants born via meconium-stained amniotic fluid (MSAF) is quite controversial. No study has tried to quantify the amount of meconium that can be aspirated from the trachea of a non-vigorous neonate born through MSAF. AIMS: To study the yield of meconium in non-vigorous neonates born through MSAF undergoing endotracheal (ET) suctioning. METHODS: This was a prospective observational study conducted from 1 March 2015 to 31 October 2015. A total of 760 neonates born through MSAF were enrolled. All non-vigorous neonates underwent ET suctioning. Meconium aspirated was quantified as nil (no meconium aspirated), insignificant (when only streaks of meconium were present in the ET tube), minimal (when the whole length of ET tube was filled with meconium) and significant (when the whole ET tube was filled with meconium and it poured into the suction tubing or when repeat suctioning was required). RESULTS: The amount of meconium aspirated from the trachea was nil to insignificant in 46% of the neonates who underwent tracheal suctioning. Only 14.4% of the neonates had significant meconium aspirated from the trachea. Almost 46% of the non-vigorous infants underwent tracheal suctioning without any important amount of meconium being aspirated from the trachea. CONCLUSION: The study further supports the recommendation put forth by the International Liaison Committee on Resuscitation (ILCOR) 2015 that selective intubation and tracheal suctioning of non-vigorous MSAF neonates might be of limited benefit. ABBREVIATIONS: ET: endotracheal; ILCOR: International Liaison Committee on Resuscitation; HIE: hypoxic ischaemic encephalopathy; LMIC: low- and middle-income countries; MAS: meconium aspiration syndrome; MSAF: meconium-stained amniotic fluid; NRP: neonatal resuscitation programme; PPHN: persistent pulmonary hypertension of the newborn; RCT: randomised controlled trial.

Early Total Enteral Feeding in Stable Very Low Birth Weight Infants: A Before and After Study.

Background: Fear of necrotizing enterocolitis (NEC) has perpetuated delayed initiation and slow advancement of enteral feeding in very low birth weight (VLBW) infants with inherent risks of parenteral alimentation. The objective of this study was to assess effect of early total enteral feeding (ETEF) on day of achievement of full enteral feeds, feed intolerance, NEC and sepsis. Methods: In total, 208 stable VLBW neonates (28-34 weeks) admitted during 6 month periods of three consecutive years were enrolled. First phase (n = 73) constituted the 'before' phase with standard practice of initial intravenous fluid therapy and slow enteral feeding. The second prospective phase (n = 51) consisted of implementation of ETEF with infants receiving full enteral feeds as per day's fluid requirement since Day 1 of life. The third phase (n = 84) was chosen to assess the sustainability of change in practice. Results: Day of achievement of full feeds was significantly earlier in Phases 2 and 3 compared with Phase 1 (8.97 and 5.47 vs. 14.44 days, respectively, p = 0.0001). Incidence of feed intolerance was comparable between Phases 1 and 2 (22 vs. 14%, p = 0.28), with marked reduction in incidence of NEC (14 vs. 4%, p = 0.028). There was a significant decrease in sepsis, duration of parenteral fluid and antibiotic therapy as well as hospital stay with comparable mortality. Conclusion: In stable preterm VLBW infants, ETEF is safe and has the benefit of optimizing nutrition with decrease in sepsis, NEC and hospital stay.

Chronic Auditory Toxicity in Late Preterm and Term Infants With Significant Hyperbilirubinemia.

BACKGROUND AND OBJECTIVES: Significant hyperbilirubinemia (SHB) may cause chronic auditory toxicity (auditory neuropathy spectrum disorder and/or sensorineural hearing loss); however, total serum bilirubin (TSB) does not discriminate neonates at risk for auditory toxicity. Our objective was to compare TSB, bilirubin albumin molar ratio (BAMR), and unbound bilirubin (UB) for their association with chronic auditory toxicity in neonates with SHB (TSB ≥20 mg/dL or TSB that met criteria for exchange transfusion). METHODS: Infants ≥34 weeks' gestational age (GA) with SHB during the first 2 postnatal weeks were eligible for a prospective longitudinal study in India. Comprehensive auditory evaluations were performed at 2 to 3 months of age by using auditory brainstem response, tympanometry, and an otoacoustic emission test and at 9 to 12 months of age by using audiometry. The evaluations were performed by an audiologist unaware of the degree of jaundice. RESULTS: A total of 93 out of 100 infants (mean GA of 37.4 weeks; 55 boys, 38 girls) who were enrolled with SHB were evaluated for auditory toxicity. Of those, 12 infants (13%) had auditory toxicity. On regression analysis controlling for covariates, peak UB (but not peak TSB or peak BAMR), was associated with auditory toxicity (odds ratio 2.41; 95% confidence interval: 1.43-4.07; P = .001). There was significant difference in the area under the receiver operating characteristic curves between UB (0.866), TSB (0.775), and BAMR (0.724) for auditory toxicity (P = .03) after controlling for covariates. CONCLUSIONS: Unconjugated hyperbilirubinemia indexed by UB (but not TSB or BAMR) is associated with chronic auditory toxicity in infants ≥34 weeks' GA with SHB.

Auditory toxicity in late preterm and term neonates with severe jaundice.

AIM: Jaundice may cause auditory toxicity (auditory neuropathy and hearing loss). However, total serum bilirubin (TSB) does not discriminate neonates at risk for auditory toxicity. We compared TSB, bilirubin:albumin molar ratio (BAMR), and unbound bilirubin for their association with auditory toxicity in neonates with severe jaundice (TSB ≥342µmol/L, or that met exchange transfusion). METHOD: Neonates greater or equal to 34 weeks gestational age with severe jaundice during the first 2 postnatal weeks were eligible for prospective cohort study, unless they had craniofacial malformations, chromosomal disorders, toxoplasmosis, other infections, rubella, cytomegalovirus, herpes simplex infections, surgery, or family history of congenital deafness. RESULTS: Twenty-eight out of 100 neonates (mean gestational age 37.4wks; 59 males, 41 females) had auditory toxicity. Peak unbound bilirubin, but not peak TSB and BAMR, was associated with auditory toxicity (p<0.05) in neonates with severe (TSB <427.5µmol/L) and extreme hyperbilirubinemia (TSB ≥427.5µmol/L). Area under the receiver operating characteristic curve for unbound bilirubin (0.78) was significantly greater (p=0.03) than TSB (0.54) among neonates with severe but not extreme hyperbilirubinemia. INTERPRETATION: Unbound bilirubin is more strongly associated with auditory toxicity than TSB and/or BAMR in greater or equal to 34 weeks gestational age neonates with severe jaundice. Unbound bilirubin is a better predictor than TSB in neonates with severe hyperbilirubinemia.

Reducing hypothermia in newborns admitted to a neonatal care unit in a large academic hospital in New Delhi, India.

Neonatal hypothermia is a common and dangerous condition around the world. 70% of neonates born in Kalawati Saran Children's Hospital in New Delhi, India, and subsequently admitted to the neonatal intensive care unit (NICU) had a temperature below 36.5°C on admission. In July 2016, we formed a team of staff from the labour room, NICU and auxiliary staff to reduce hypothermia in babies transported to our NICU using quality improvement methods. We identified problems related to staff awareness of hypothermia and its dangers, environmental factors and supply issues in the labour room, and challenges with rapidly and safely transferring sick newborns to the NICU. We used the Plan-Do-Study-Act cycles to test and adapt solutions to these problems. Because infection is a common complication of hypothermia, we also instituted a training programme to improve handwashing skills among parents and health workers. Within 9 months of starting our quality improvement project, the proportion of neonates who were normothermic on admission increased from 27% to 75%, the number of cases of late-onset neonatal sepsis decreased from 15.2 to 5 cases/1000 patient days, and all-cause mortality fell from 4.2 to 2.6 neonatal deaths per week. Multiple factors can lead to neonatal hypothermia, and the most important factors will differ from facility to facility. Quality improvement methods provide health workers with the skills to identify the key factors contributing to hypothermia in their facility and to develop strategies to address them. Addressing processes of care can lead to improved thermal care and save lives.

Endotracheal suction in term non vigorous meconium stained neonates-A pilot study.

AIM: To evaluate the effect of 'No endotracheal suction' on occurrence of meconium aspiration syndrome (MAS) and/or all-cause mortality in non-vigorous neonates born through meconium stained amniotic fluid (MSAF). METHODS: This pilot randomized controlled trial enrolled term non-vigorous neonates (≥37 weeks) born through MSAF. Neonates randomized to 'No Endotracheal suction group' ('No ET' Group; n=88) did not undergo endotracheal suction before the definitive steps of resuscitation. Neonates randomized to 'Endotracheal suction group' ('ET' Group; n=87) underwent tracheal suction as part of the initial steps as per the current NRP recommendations. The primary outcome was occurrence of MAS and/or death. Secondary outcome variables were duration and severity of respiratory distress, need for respiratory support, development of hypoxic ischemic encephalopathy (HIE) and duration of oxygen therapy and hospitalization. RESULTS: Baseline characters including birth weight and gestational age were similar between the two groups. MAS was present in 23 (26.1%) vs. 28 (32.2%) neonates in 'No ET' and 'ET' groups respectively (OR 0.4 (0.12-1.4); p=0.14) with 4 (4.6%) and 9 (10.34%) deaths amongst these neonates with MAS in respective groups (OR 0.75 (0.62-1.2); p=0.38). Other parameters like severity and duration of respiratory distress, need for respiratory support, incidence of HIE, duration of oxygen therapy and duration of hospitalization were comparable. CONCLUSION: This study demonstrates that it is feasible to randomize non-vigorous infants born through meconium stained liquor to receive on not receive endotracheal suction. There is a need for a multi-center trial to address whether the current practices and guidelines can be justified.

Incidence, Etiology and Risk Factors Associated with Neonatal Healthcare-Associated Conjunctivitis: A Prospective Study from a Tertiary Care Hospital in India.

INTRODUCTION: Healthcare-associated conjunctivitis (HAC) can lead to serious sequelae including blindness. We conducted a one-year prospective study to determine the epidemiology of neonatal HAC at a tertiary-care hospital in India. METHODS: From the neonates fulfilling a set of predefined inclusion criteria, cases of HAC were diagnosed based on CDC guidelines. Conjunctival swabs, obtained from neonates with suggestive clinical signs, were processed using standard protocols. Twenty-eight potential risk factors were analyzed. RESULTS: We detected 24 cases of HAC among 591 enrolled neonates, with Escherichia coli being the most frequently isolated microorganism. On multivariate analysis, intubation at birth (p = 0.046) and orogastric feeding (p = 0.029) had a statistically significant association with neonatal HAC. Average hospitalization increased from 9.6 to 20.8 days for neonates diagnosed with HAC. CONCLUSION: A standardized case-definition and physician awareness of potential serious sequelae would help improve detection rates and timely institution of therapy. Hand hygiene could help control the menace of neonatal HAC.

Effect of intrapartum oropharyngeal (IP-OP) suction on meconium aspiration syndrome (MAS) in developing country: A RCT.

OBJECTIVE: Evidence about IP-OP suction and selective tracheal intubation in meconium stained neonates is from developed countries. Little information is available about their role in developing countries with high incidence of meconium staining and MAS. This randomized trial was planned to evaluate the effectiveness of IP-OP suction in meconium stained term neonates on prevention of MAS and reduction of its severity. PATIENTS AND METHODS: Out of 540 meconium stained full term, cephalic presentation, singleton neonates without major congenital malformations born from June'08 to January'09, 31 were excluded and 509 randomized. In the intervention group IP-OP suction was done at the time of delivery of head using a 10 Fr suction catheter with a negative pressure of 100 mmHg. No IP-OP suction was performed in control group. All neonates with MSAF were assessed as vigorous or non-vigorous after birth and provided care as per NRP guidelines 2005. RESULTS: Two hundred and fifty three neonates were randomized to IP-OP suction and 256 to no IP-OP suction. Eighty-two neonates (16%) developed MAS, the primary outcome parameter, with 40 infants in the intervention group (15.8%) and 42 (16.4%) in the non-intervention group (RR 0.86, 95% CI 0.60-1.54). Incidence of severe MAS was comparable (3.55% vs. 2.34%) (P value=0.40). Other variables like requirement of oxygen >48 h (9.8% vs. 10.5%) and mortality (2.7% vs. 1.7%) were also comparable. CONCLUSIONS: IP-OP suctioning did not reduce the incidence or severity of MAS even in a setting of high incidence of MAS in a developing country. The mortality in two groups was comparable.

Role of Serum Levels of Vascular Endothelial Growth Factor and Its Receptor in Retinopathy of Prematurity.

BACKGROUND: Retinopathy of prematurity (ROP) is a disorder of developing retina of low birth weight preterm infants which can lead to blindness. One theory attributes the fibrosis seen in ROP to deregulation of vascularization in the retina. Vascular endothelial growth factor (VEGF) is one of the important mediators involved in vascularization. OBJECTIVES: This study was carried out to assess the role of VEGF and its receptor in retinopathy of prematurity. PATIENTS AND METHODS: Around 200 preterm infants born in SSK hospital were screened at 33 - 34 weeks. These babies were followed up according to the international classification of retinopathy of prematurity (ICROP) criteria. Those infants who developed ROP at 38 - 40 weeks were enrolled in group A while an equal number of infants who did not develop ROP were included in group B. Each group comprised of 30 subjects each. Venous sampling was carried out twice, once at 33 - 34 weeks and then again at 38 - 40 weeks. VEGF and VEGF-R2 were estimated by commercially available ELISA kits. RESULTS: There was no statistically significant difference between the levels of VEGF and VEGF-R2 in both groups at first visit as well as the follow up visit. However, the intra-group difference was significant between the first and the final visit in VEGF and VEGF-R2 levels in the cases with ROP. In the control population, the VEGF levels were significantly lower in the follow up visit as compared to the initial visit. CONCLUSIONS: Our study demonstrates that a significant difference is seen in the serum VEGF and VRGF-R2 in the second visit of the infants with ROP demonstrating that VEGF might be responsible for the initiation and aggravation of ROP.

Role of prophylactic antibiotics in neonates born through meconium-stained amniotic fluid (MSAF)--a randomized controlled trial.

UNLABELLED: The objective of the study was to evaluate the effect of administering prophylactic antibiotics on the development of neonatal sepsis in term neonates born through meconium-stained amniotic fluid (MSAF). Two hundred and fifty eligible neonates were randomized to study group (Antibiotic group-receiving first-line antibiotics for 3 days) and control group (No Antibiotic group). Both groups were evaluated clinically and by laboratory parameters (sepsis screen and blood cultures) for development of sepsis. All neonates were monitored for respiratory, neurological, and other systemic complications and received supportive treatment according to standard management protocol of the unit. One hundred and twenty one neonates were randomized to 'Antibiotic' group and 129 to 'No Antibiotic' group. The overall incidence of suspect sepsis was 9.6 % in the study population with no significant difference between 'No Antibiotic' and 'Antibiotic' groups (10.8 vs. 8.2 %, p = 0.48, odds ratio (OR) 0.74, 95 % confidence interval (CI) 0.32-1.73). Incidence of culture-proven sepsis was also not significantly different between the two groups (5.42 vs. 4.13 %, p = 0.63, OR 0.75, 95 % CI 0.23-2.43). The incidence of mortality, meconium aspiration syndrome, and other complications was comparable amongst the two groups. CONCLUSION: Routine antibiotic prophylaxis in neonates born through MSAF did not reduce the incidence of sepsis in this study population. (Clinicaltrials.gov no. - NCT01290003).

Risk factors for carbapenem-resistant Acinetobacter baumanii blood stream infections in a neonatal intensive care unit, Delhi, India.

INTRODUCTION: Carbapenem-resistant Acinetobacter baumannii (CRAB) infection is being increasingly observed and is associated with significant morbidity and mortality in newborns. In this study, we determined the epidemiology, risk factors, and outcomes of blood stream infection (BSI) caused by CRAB in neonates. METHODOLOGY: The clinical charts of neonates who developed Acinetobacter baumannii BSI in the period between 1 January 2010 and 31 December 2012 were reviewed. RESULTS: During the study period, 65 neonates developed Acinetobacter baumannii BSI; 33 were CRAB at an incidence of 0.50 case per 1,000 patient-days. Compared with carbapenem-sensitive Acinetobacter baumannii (CSAB), patients with CRAB BSI had significantly higher prior antimicrobial use, longer duration of ventilation, and late isolation of organisms. Feeding with expressed breast milk was protective. All isolates of Acinetobacter baumenii were sensitive to colistin and tigecycline. The all-cause mortality rates were 27.3% in CRAB and 9.4% in CSAB BSI, respectively (p = 0.074). CONCLUSIONS: Neonatal BSI caused by CRAB was not common but caused high mortality. Feeding with breast milk was protective. Lack of effective antibiotics was the major challenge in treating these patients.

Ventricular tachycardia due to perinatal asphyxia.

BACKGROUND: Perinatal asphyxia is known to precipitate myocardial dysfunction, rhythm abnormalities and congestive cardiac failure. CASE CHARACTERISTICS: A 2-day old neonate with perinatal asphyxia. OBSERVATION: He developed shock secondary to ventricular tachycardia, and required synchronized cardioversion for reversion of abnormal rhythm. OUTCOME: Reversal of arrhythmia leading to recovery. MESSAGE: Early identification and management of ventricular tachycardia in neonate with perinatal asphyxia can be life-saving.

Skin dimples.

Skin dimples are a common occurrence in children. Besides being of cosmetic significance, they may give an important clue to an underlying genetic or metabolic problem. A simplified location-based algorithmic approach to diagnose the underlying cause of skin dimples is presented. Clinical significance of medically important dimples, especially sacral dimples, its association with occult spinal dysraphism, and a cost-effective diagnostic strategy for its imaging is discussed.