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ObjectiveThe paucity of specialised care in the peripheral areas of developing countries necessitates the referral of sick neonates to higher centres. Organised interhospital transport services provided by a skilled and well-equipped team can significantly improve the outcome. The present study evaluated the transport characteristics and predictors of mortality among neonates referred to a tertiary care centre in North India.DesignProspective observational study.SettingsTertiary care teaching hospital in North India.Patients1013 neonates referred from peripheral health units.Main outcome measuresMortality among referred neonates on admission to our centre.ResultsOf the 1013 enrolled neonates, 83% were transferred through national ambulance services, 13.7% through private hospital ambulances and 3.3% through personal vehicles. Major transfer indications were prematurity (35%), requirement for ventilation (32%), birth asphyxia (28%) and hyperbilirubinaemia (19%). Hypothermia (32.5%, 330 of 1013), shock (19%, 192 of 1013) and requirement for immediate cardiorespiratory support (ICRS) (10.4%, 106 of 1013) on arrival were the major complications observed during transfer. A total of 305 (30.1%, N=1013) deaths occurred. Of these, 52% (n=160) died within 24 hours of arrival. On multivariate logistic analysis, unsupervised pregnancy (<4 antenatal visits; p=0.037), antenatal complications (p<0.001), prematurity ≤30 weeks (p=0.005), shock (p=0.001), hypothermia (p<0.001), requirement for ICRS on arrival (p<0.001), birth asphyxia (p=0.004), travel time >2 hours (p=0.005) and absence of trained staff during transfer (p<0.001) were found to be significant predictors of mortality.ConclusionThe present study depicts high mortality among infants referred to our centre. Adequate training of peripheral health personnel and availability of pre-referral stabilisation and dedicated interhospital transport teams for sick neonate transfers may prove valuable interventions for improved outcomes.

ObjectiveDefinitive guidance regarding the duration of antibiotics for neonatal sepsis is lacking. We hypothesised that a 7-day antibiotic course is non-inferior to a 14-day course for treating culture-proven sepsis.DesignRandomised, controlled, non-inferiority trial with masked outcome assessment in eight centres in a low and middle-income country.PatientsNeonates with a birth weight (BW) ≥1000 g and blood culture-proven sepsis were randomised on day 7 of sensitive antibiotic therapy provided sepsis had clinically remitted. Exclusions: Staphylococcus aureus or fungal sepsis, and infections requiring prolonged antibiotics. We planned to enrol 350 per group, assuming 10% rate of primary outcome, +7% non-inferiority margin, one-sided 5% alpha, 90% power, 10% loss to follow-up.Intervention7 days (no further treatment); comparison: 14 days (7 days postrandomisation).OutcomesPrimary: relapse (definite or probable) within day 21 postantibiotic completion. Secondary outcomes: composite of mortality or definite/probable/secondary sepsis and duration of hospitalisation. One interim analysis (per protocol (PP)) was planned.Results126 and 135 subjects were recruited in 7-day and 14-day groups, respectively, with mean (SD) birth weight (BW) 2250.9 (741.1) and 2187.8 (718.8) g. The trial was terminated early, based on interim PP analysis. 2/125 and 6/130 subjects had the primary outcome in 7-day and 14-day groups, respectively (risk difference (RD)=−3.0% (99.5% CI −9.2%, +3.1%), below non-inferiority margin). The composite secondary outcome also favoured the 7-day regimen (RD: −3.7% (99.5% CI −12.4% to +5.1%)). Duration of hospitalisation was shorter in 7-day group (median difference: −4 days (95% CI −5 to –3)).ConclusionsA 7-day course of antibiotics may be non-inferior to a 14-day course for uncomplicated bacterial neonatal sepsis.Trial registration number NCT03280147.

Recent advances in the perinatal interventions for neonates with congenital diaphragmatic hernia have remarkably improved the outcome in developed countries, but high mortality for such cases continues to be a challenge in resource-poor settings. This study examines clinical profiles and short-term outcome of neonates with congenital diaphragmatic hernia, using a retrospective analysis of medical records of neonates operated for congenital diaphragmatic hernia at a tertiary care center in North India from January 2001 to December 2016. Forty-two neonates were operated during the study period with male:female ratio = 1.6:1. Postoperative survival rate was 69% (29/42). Average birth weight in the survivors was 2528±267 g as compared with 2132±309 g in the non-survivors. The average gestational age in the two groups was 37.2±0.8 weeks and 34.8±1.8 weeks respectively. Twenty-one patients presented in the initial 48 h of life, out of them 52% (11/21) survived. Congenital heart diseases were associated with seven and malrotation of the gut in five neonates. The most significant factors resulting in the unfavorable outcome were preterm gestation, low birth weight, hypothermia and shock at presentation, the onset of symptoms <48 h of life, liver-up, need of postoperative inotropes and mechanical ventilation. In addition to establishing advanced therapeutic modalities, good antenatal screening, better awareness in peripheral health workers about the malformation leading to timely referral, well-equipped inter-hospital and intra-hospital transport facilities and development of level III neonatal intensive care units can improve survival in neonates with congenital diaphragmatic hernia in developing countries.

ObjectivesBeta-thalassemias are one of the commonest genetic hemoglobin disorder. Regular blood transfusions are the cornerstone interventions in the management of thalassemia patients. However, repeated blood transfusion is associated with iron overload and an increased risk of transfusion-transmitted infections (TTIs). In the present review, we analyzed the prevalence of viral (HBV, HCV, and HIV) TTIs among multi-transfused beta-thalassemia patients in LMICs.MethodsTwo different electronic databases (PubMed and DOAJ) were searched for articles reporting TTIs in multi-transfused beta-thalassemia patients from LMICs. Data regarding the prevalence of hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) along with significant associated factors were extracted.ResultsA high prevalence of viral disease markers were noted among beta-thalassemia patients. HCV was the most prevalent TTI (10 – 89.2%) followed by HBV (0 – 10.8%). HIV was the least commonly seen in TTI (0 – 9%). A higher prevalence of TTIs was observed in the Indian subcontinent with a much higher prevalence than in the donor population. None of the studies mentioned nucleic acid amplification as a screening intervention for the stored blood products before transfusion. Older age, frequent blood transfusions, and increased duration of disease are the significant factors associated with a higher risk of TTIs.ConclusionHigh seroprevalence of viral TTIs had been noticed in multi-transfused thalassemia patients. Implementation of strict hemovigilance policies and NAT screening in blood banks may be helpful to minimize the TTIs. In addition, hepatitis B immunization should be actively done before transfusions in thalassemia patients. Thalassemia care centers shall be provided an adequate supply of therapeutics drugs e.g. direct-acting agents for HCV for appropriate management of these patients. Better community awareness and promoting voluntary blood donation are other interventions that may be very helpful in curtailing the risk of TTIs.

Background: Meckel's diverticulum (MD) is the one of the most common congenital malformation of gastrointestinal tract and has varied clinical presentations. We are presenting here our 12-year experiences with MD in children at tertiary care hospital in North India. It highlights the fact that isolated gangrene of MD can occur, and it is associated with increased morbidity. Materials and Methods: This retrospective study is conducted by analysing the medical records of the patients who were operated for MD in the last 12 years in paediatric surgery department at our hospital. Results: Sixty-five patients were operated for MD in study period; in this 52 were males and 13 were females with mean age of presentation 3.2 years. The most common presentation was intestinal obstruction seen in 86.1% (56 cases). Intestinal haemorrhage was seen in 4.6% (3 cases) and diverticulitis in 3% (2 cases). Perforation of the gut with peritonitis was present in 6.1% (four cases). Cause of obstruction was intussusception in 21.4% (12 cases), fibrous band connected to umbilicus in 17.8% (10 cases), volvulus in 17.8% (10 cases), kinking in 16.0% (9 cases), knotting in 14.2% (8 cases) and herniation of gut below in 12.5% (7 cases). Isolated gangrene of MD was present in ten cases with intestinal obstruction. The ectopic gastric mucosa was seen in three and pancreatic mucosa in two cases. Mortality and morbidity during the study were one and three cases, respectively. Conclusion: MD may remain clinically silent for lifetime, or it may have life-threatening complications. In our series, intestinal obstruction and not the haemorrhage was the most common presentation. Isolated gangrene of MD with obstruction was present in significant numbers, which we failed to find in literature.

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.

Comment The diagnosis of vascular lesions such as infantile haemangioma, Kaposiform haemangioendothelioma (KHE), tufted angioma (TA) and vascular malformations are usually established by clinical features, radio-imaging and immunohistochemical markers.1 Benign vascular neoplasm KHE has a wider age of presentation then infantile haemangioma. Similarly, TA presents in infants, children or young adults and are usually located on the neck or the upper part of the thorax. Both, KHE and TA have glucose transporter protein isoform (GLUT1) negative endothelial cells and may be associated with thrombocytopaenia. Vascular malformations are congenital lesions that sometimes become apparent later in life and do not involute spontaneously. Haemangiomas are the most common benign soft tissue tumours in infants, found in 4–10% with higher female preponderance.2 Haemangiomas are seen most commonly in the craniofacial region (60%), followed by the trunk (25%) and extremities (15%). Immunohistochemical markers such as GLUT1 can be useful for differentiating haemangiomas from other vascular lesions.3 After a rapidly proliferative phase during the early infantile period, most uncomplicated lesions undergo spontaneous slow involution and an active non-intervention approach may be preferred.4 However, some children require further intervention due to associated complications. Therapeutic interventions are based on the location, size of haemangioma, age of the patient, presence of complications and experts’ and parents’ preferences. Beta-blockers (e.g. oral propranolol) haveshown promising results in uncomplicated haemangiomas; however, detailed cardiovascular and respiratory evaluation is required before initiating these drugs.5 Oral propranolol therapy is usually given for 6–12 months depending on the size and location of the lesion. In recent years, the use of corticosteroids to treat haemangiomas has decreased and is only used when beta-blockers are contraindicated.4 Other medications such as vincristine, interferon-α and imiquimod may be useful but are rarely used due to their serious side-effects. Recently, the common antifungal agent itraconazole has been found to be useful in the treatment of infantile haemangioma by inhibiting proliferation and promoting apoptosis of infantile primary haemangioma endothelial cells.6 In addition to pharmacological treatment, laser therapy and surgical interventions are alternative treatment options. Although pulsed-dye laser treatment has debatable efficacy, they may be used on superficial lesions.7 Excisional surgery may be undertaken when the haemangioma causes visual or subglottic obstruction, bleeding or recurrent ulceration as well as slow involution or failure of pharmacological treatment.5

Severe pulmonary tuberculosis (TB) complicated by deep vein thrombosis (DVT) in adults has been reported previously in the medical literature; however, childhood extrapulmonary TB complicated by DVT is rare. We report a 13-year-old girl who presented to the Department of Pediatrics at the Postgraduate Institute of Medical Sciences in Rohtak, India, in 2012 with abdominal TB complicated by DVT and intracranial sinus thrombosis. She was treated with a course of four antitubercular drugs and short-term anticoagulation therapy with a positive outcome over the next six months. To the best of the authors’ knowledge, no previous reports have yet suggested a possible association between childhood TB and intracranial sinus thrombosis.

ObjectivesKangaroo mother care (KMC) uptake is low despite KMC being an evidence based tool to decrease neonatal mortality. It is important that local strategies be developed to enhance KMC usage. This study aimed to assess the effect of implementing an education protocol on the usage of KMC in the NICU and at home after discharge.MethodsPreterm mother-infant dyads admitted to the NICU were enrolled prospectively. In initial 3 mo, baseline data on KMC usage in the unit and at home after discharge was collected. In the next three months, a KMC education protocol consisting of one-to-one counseling, education and sensitization of the mother and family members regarding benefits and procedure of KMC and focussed group discussions was implemented such that it became a unit work protocol. In the next 3 mo, data on KMC usage in the unit and at home after discharge was again collected and compared with the baseline data.ResultsImplementation of the education protocol resulted in earlier initiation of KMC (2.49 ± 0.67 vs. 4.65 ± 0.99 d, p < 0.05); increased duration of KMC (8 h/d vs. 3 h/d, p < 0.05); a higher proportion of eligible preterms receiving KMC during hospital stay (100% vs. 75%, p < 0.05) and at home (87% vs. 28%, p < 0.05) and KMC being provided more often by other family members (27.1% vs. 5.7%, p < 0.05).ConclusionsImplementation of a KMC education protocol resulted in improved KMC usage in the unit and at home 4 wk after discharge.

ObjectiveTo evaluate the epidemiology of rotavirus gastroenteritis in Haryana post-introduction of rotavirus vaccine. Expanded National rotavirus surveillance network in India reported high burden of rotavirus diarrhea in India. The Government of India introduced the monovalent rotavirus vaccine made in India by Bharat Biotech in the national immunization programme from 2016 onward along with oral polio vaccine (OPV) and Pentavalent vaccines.MethodsA multi-centric, hospital-based surveillance study in the initial vaccine introducing states was started in a phased manner over a period of 3 y. PGIMS, Rohtak is a tertiary care center and was a part of the surveillance from 2016 to 2019. Children aged 0–59 mo admitted with acute gastroenteritis were enrolled into the surveillance and their stool samples were collected. Samples were tested at Christian Medical College (CMC), Vellore to detect rotavirus and reverse transcription-polymerase chain reaction (RT-PCR) was used for G and P typing.ResultsA total of 904 children were enrolled in the present surveillance over a period of 3 y starting 1st July 2016 to 30th June 2019. Stool samples were collected and analyzed for 827 children and out of them 141 samples were positive for rotavirus (17.1%). Maximum rotavirus positivity was observed during the winter months. Rotavirus positivity percentage was observed maximum in 12–23 mo age group. A declining trend was observed in rotavirus positivity from 22.8% in 2016 to 14.5% in 2019. Most common strains of rotavirus isolated were G3P[8] followed by G1P[8].ConclusionThis study highlights that epidemiology of acute gastroenteritis among children less than 5 y of age in Haryana postintroduction of rotavirus vaccination in the state and the decline in rotavirus positivity from 22.8% in 2016 to 14.5% in 2019.