Severe Infections In Young Infants Research Articles

Microbiological Profile and Sensitivity Data among the Neonatal Population from a Tertiary Care Hospital in South India

Background: Sepsis is one of the most common causes of mortality and morbidity among neonates. The prevalence of microorganisms varies with regions, and the sensitivity pattern also changes over time. 
 Aim: To study the prevalence of various microorganisms and their sensitivity pattern among the neonatal population in a tertiary care hospital in South India.
 Methods: This was a retrospective descriptive study. We screened the records of all neonates admitted to the hospital during a period starting from January 1st, 2016, to September 30th, 2018. The details of the patients with any sterile body fluids showing microbial growth were collected. Descriptive analysis was done using IBM SPSS version 20.
 Results: There were 77 organisms isolated during the study period, with the majority among outborn babies. Seventy-two isolates were from blood, two from CSF and urine, with one from the central line. The most common organism was Klebsiella (22%), followed by Burkholderia cepacia (12%), Staphylococcus aureus (9%), and Streptococcus agalactiae (7%). 9% of the organisms were fungus, with the most common being Kodamaea Ohmeri. Among the antibiotics tested for sensitivity, Meropenem had the maximum sensitivity ratio (84%), followed by Co-trimoxazole (83%) and Vancomycin (82%). Piperacillin tazobactam sensitivity was only 56%, and Ciprofloxacin was sensitive in 65% of cases. Most (6 out of 7) of the fungal isolates were sensitive to fluconazole.
 Conclusions: Klebsiella remains to be the most common organism causing severe infection in young infants. Worrying rise in the incidence of uncommon organisms (like Kodamaea Ohmeri, GBS, Burkholderia) and carbapenem resistance was noted. It is, therefore, essential to update the antibiotic policy of the neonatal units on a timely basis.

323. Childhood Outcomes Following Parechovirus Central Nervous System Infection in Young Infants at a US Children’s Hospital

BackgroundParechovirus (PeV), specifically Parechovirus A type 3 (PeV-A3), is a picornavirus associated with severe infection in young infants, with disease manifestations ranging from undifferentiated fever, to sepsis like illness, and meningoencephalitis. There are limited data regarding long-term outcomes of infected infants. The objective of this study was to describe early childhood outcomes following infantile PeV-CNS infectionMethodsFamilies of Infants hospitalized during 2014 with laboratory confirmed PeV-CNS infection were contacted for neurodevelopmental follow-up. Testing included medical history, standard neurologic examination, parental completion of Ages and Stages questionnaire (ASQ) and determination of Bayley III cognitive, motor, and language quotients. Neurodevelopmental impairment (NDI) was considered present if cognitive, motor, or language quotients were >1 standard deviation (mild) or >2 SD (severe) below the testing norms, the presence of cerebral palsy (CP), or sensory (vision/hearing) impairment. Relationship of childrens’ outcomes to severity of PeV disease (uncomplicated febrile illness [mild], disseminated disease [moderate] or advanced disease requiring intensive care [severe]) was assessed by chi-square analysis.ResultsNineteen children were available for testing at approximately 3 years of age (31–38 months), 12 (63%) with mild, five (26%) moderate, and two (11%) with severe disease. Mean Bayley quotients were within normal limits (see table), one infant had mild CP (5%) and two (11%) had mild NDI. There was no apparent relationship of NDI with infant PeV clinical presentation. ASQ results included 11% at referral level and 32% suspect, and were unrelated to severity of the viral illness. However, all parents of children with moderate or severe presentations of infantile PeV disease had medical or behavior concerns at 3 years of age compared with 25% of those with mild presentation (P = 0.007).Bayley QuotientsMeanRangeIQ9885–125Motor10891–130Language10389–118ConclusionNeurodevelopmental impairments may be seen following infant PeV disease, but may not correlate with severity of clinical disease. Longitudinal monitoring of developmental status through early childhood following PeV infantile disease is warranted.Disclosures All authors: No reported disclosures.

Simplified antibiotic regimens for treating neonates and young infants with severe infections in the Democratic Republic of Congo: a comparative efficacy trial.

BackgroundOne-quarter of neonatal and infant deaths are due to infection, and the majority of these deaths occur in developing countries. Standard treatment for infection, which includes parenteral treatment only, is often not available in low-resource settings. Infant mortality will not be reduced in developing countries without a reduction in deaths due to infection. We participated in a multi-site trial that demonstrated the effectiveness of three simplified antibiotic regimens compared to standard treatment (The AFRINEST Trial: parent study). For this report, we examined the site-specific data for the Democratic Republic Congo (DRC), the most impoverished of the countries that participated in the study, to determine if outcomes in the DRC were similar to outcomes across all sites.MethodsThe parent study was an individually randomized, open-label, equivalence trial. Infants with clinical signs of severe infection were randomized to receive one of four regimens: 1) injectable penicillin-gentamicin for 7 days (standard therapy; regimen A), 2) injectable gentamicin and oral amoxicillin for 7 days (regimen B), 3) injectable penicillin-gentamicin for 2 days then oral amoxicillin for 5 days (regimen C), or 4) injectable gentamicin for 2 days and oral amoxicillin for 5 days (regimen D). In the DRC, we enrolled 574 infants, of whom 560 met the per-protocol criteria for analysis of treatment effect. The main outcome was treatment failure within the first week of enrollment.ResultsTreatment failure occurred in 52 (9.3%) infants: 17 (11.6%) with the referent treatment regimen, 13 (9.6%) with regimen B (risk difference [RD] -2.0%; CI -9.2% to 5.2%), 13 (9.0%) with regimen C (RD -2.6%; CI -9.6% to 4.4%), and 9 (6.7%) with regimen D (RD -5.0%; CI -11.7% to 1.7%).ConclusionAs in the parent study, the risk difference between each of the experimental treatments and the reference treatment suggests equivalence. These findings suggest that the conclusion from the parent study, that a simplified antibiotic regimen can be used for the community-based management of possible severe infection in young infants where referral to a hospital for standard care is often not possible, is true in the DRC. We speculate that the widespread use of a simplified, community-based treatment could result in increased coverage with treatment and improved survival in poor areas.Trial registrationACTRN12610000286044 on April 9, 2010.

Zinc as an adjunct treatment for reducing case fatality due to clinical severe infection in young infants: study protocol for a randomized controlled trial

BackgroundAn estimated 2.7 of the 5.9 million deaths in children under 5 years of age occur in the neonatal period. Severe infections contribute to almost a quarter of these deaths. Mortality due to severe infections in developing country settings is substantial despite antibiotic therapy. Effective interventions that can be added to standard therapy for severe infections are required to reduce case fatality.Methods/DesignThis is a double-blind randomized placebo-controlled parallel group superiority trial to investigate the effect of zinc administered orally as an adjunct to standard therapy to infants aged 3 days up to 2 months (59 days) hospitalized with clinical severe infection, that will be undertaken in seven hospitals in Delhi, India and Kathmandu, Nepal. In a 1:1 ratio, we will randomly assign young infants to receive 10 mg of elemental zinc or placebo orally in addition to the standard therapy for a total of 14 days. The primary outcomes hospital case fatality, which is death due to any cause and at any time after enrolment while hospitalized for the illness episode, and extended case fatality, which encompasses the period until 12 weeks after enrolment.DiscussionA previous study showed a beneficial effect of zinc in reducing the risk of treatment failure, as well as a non-significant effect on case fatality. This study was not powered to detect an effect on case fatality, which this current study is. If the results are consistent with this earlier trial, we would have provided strong evidence for recommending zinc as an adjunct to standard therapy for clinical severe infection in young infants.Trial registrationUniversal Trial Number: U1111-1187-6479, Clinical Trials Registry – India: CTRI/2017/02/007966: Registered on February 27, 2017.

Safety and efficacy of alternative antibiotic regimens compared with 7 day injectable procaine benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible: a randomised, open-label, equivalence trial.

Severe infections remain one of the main causes of neonatal deaths worldwide. Possible severe infection is diagnosed in young infants (aged 0-59 days) according to the presence of one or more clinical signs. The recommended treatment is hospital admission with 7-10 days of injectable antibiotic therapy. In low-income and middle-income countries, barriers to hospital care lead to delayed, inadequate, or no treatment for many young infants. We aimed to identify effective alternative antibiotic regimens to expand treatment options for situations where hospital admission is not possible. We did this randomised, open-label, equivalence trial in four urban hospitals and one rural field site in Bangladesh to determine whether two alternative antibiotic regimens with reduced numbers of injectable antibiotics combined with oral antibiotics had similar efficacy and safety to the standard regimen, which was also used as outpatient treatment. We randomly assigned infants who showed at least one clinical sign of severe, but not critical, infection (except fast breathing alone), whose parents refused hospital admission, to one of the three treatment regimens. We stratified randomisation by study site and age (<7 days or 7-59 days) using computer-generated randomisation sequences. The standard treatment was intramuscular procaine benzylpenicillin and gentamicin once per day for 7 days (group A). The alternative regimens were intramuscular gentamicin once per day and oral amoxicillin twice per day for 7 days (group B) or intramuscular procaine benzylpenicillin and gentamicin once per day for 2 days, then oral amoxicillin twice per day for 5 days (group C). The primary outcome was treatment failure within 7 days after enrolment. Assessors of treatment failure were masked to treatment allocation. Primary analysis was per protocol. We used a prespecified similarity margin of 5% to assess equivalence between regimens. This study is registered with ClinicalTrials.gov, number NCT00844337. Between July 1, 2009, and June 30, 2013, we recruited 2490 young infants into the trial. We assigned 830 infants to group A, 831 infants to group B, and 829 infants to group C. 2367 (95%) infants fulfilled per-protocol criteria. 78 (10%) of 795 per-protocol infants had treatment failure in group A compared with 65 (8%) of 782 infants in group B (risk difference -1.5%, 95% CI -4.3 to 1.3) and 64 (8%) of 790 infants in group C (-1.7%, -4.5 to 1.1). In group A, 14 (2%) infants died before day 15, compared with 12 (2%) infants in group B and 12 (2%) infants in group C. Non-fatal relapse rates were similar in all three groups (12 [2%] infants in group A vs 13 [2%] infants in group B and 10 [1%] infants in group C). Our results suggest that the two alternative antibiotic regimens for outpatient treatment of clinical signs of severe infection in young infants whose parents refused hospital admission are as efficacious as the standard regimen. This finding could increase treatment options in resource-poor settings when referral care is not available or acceptable.

A Case of Neonatal Septic Arthritis Caused by Group B Streptococcus

Group B streptococcus (also indicated as streptococcus agalactiae) is a well-known cause of severe infections in younginfants but also an unusual microorganism to be isolated in case of septic arthritis, especially in newborns in Korea. Wereport a case of monoarticular septic arthritis caused by group B streptococcus in a 22-day-old baby.

Intention to accept Bordetella pertussis booster vaccine during pregnancy in Mexico City

ObjectiveAdult booster vaccination against pertussis can help prevent severe infections in young infants. We examined influences on intention to accept pertussis booster vaccination among pregnant women in Mexico City. MethodsWe conducted a cross-sectional survey, recruiting convenience samples of pregnant women receiving prenatal care from three public healthcare centers between March and May 2012. Our primary outcome was intention to accept pertussis vaccination during pregnancy. We examined socio-demographic factors, vaccination history, pertussis knowledge, perceptions of vaccine information sources, and other potential influences on vaccine decision-making. ResultsA total of 402 pregnant women agreed to participate, of which 387 (96%) provided their intention to accept or decline pertussis vaccination. Among respondents, 57% intended to accept a pertussis booster vaccine if offered, but only 16% had ever heard of pertussis, and only 2% knew someone who had contracted this disease. Over 80% of respondents would accept pertussis vaccination if recommended by an obstetrician-gynecologist. The most frequently selected reasons to refuse pertussis vaccination were concerns that the vaccine might harm the unborn baby or pregnant woman. In multivariate analysis, rating doctors and nurses as good sources of vaccine information, and having ever heard of pertussis, were independently associated with intention to accept pertussis vaccination. ConclusionsPromoting patient awareness about pertussis disease and vaccine safety, and encouraging general practitioners, nurses and obstetricians to recommend pertussis booster vaccine, may increase vaccine uptake among pregnant women.

Ongoing Trials of Simplified Antibiotic Regimens for the Treatment of Serious Infections in Young Infants in South Asia and Sub-Saharan Africa

Background:The current World Health Organization (WHO) recommendation for treatment of severe infection in young infants is hospitalization and parenteral antibiotic therapy. Hospital care is generally not available outside large cities in low- and middle-income countries and even when available is not acceptable or affordable for many families. Previous research in Bangladesh and India demonstrated that treatment outside hospitals may be possible.Research:A set of research studies with common protocols testing simplified antibiotic regimens that can be provided at the lowest-level health-care facility or at home are nearing completion. The studies are large individually randomized controlled trials that are set up in the context of a program, which provides home visits by community health workers to detect serious illness in young infants with assessment and treatment at an outpatient health facility near home. This article summarizes the policy implications of the research studies.Policy Implications:The studies are expected to result in information that would inform WHO guidelines on simple, safe and effective regimens for the treatment of clinical severe infection and pneumonia in newborns and young infants in settings where referral is not possible. The studies will also inform the inputs and process required to establish outpatient treatment of newborn and young infant infections at health facilities near the home. We expect that the information from research and the resulting WHO guidelines will form the basis of policy dialogue by a large number of stakeholders at the country level to implement outpatient treatment of neonatal infections and thereby reduce neonatal and infant mortality resulting from infection.

An Innovative Multipartner Research Program to Address Detection, Assessment and Treatment of Neonatal Infections in Low-resource Settings

Background:In pursuit of innovative approaches for the management of severe infections in young infants, which is a major cause of mortality, a multipartner research program was conceptualized to provide right care in the right place. The primary objective was to generate evidence and identify a simple, safe and effective treatment regimen for young infants with severe infections that can be provided closer to home by trained health workers where referral is not possible.Research:Published and nonpublished data on community-based approaches for the management of neonatal sepsis were critically reviewed by an independent expert panel convened in 2007 by the World Health Organization in collaboration with the United States Agency for International Development and Save the Children/Saving Newborn Lives. These stakeholders agreed to 1) undertake research to improve the specificity of a diagnostic algorithm and revise World Health Organization/United Nations International Children’s Emergency Fund Integrated Management of Childhood Illness guidelines to identify sick young infants for referral, 2) develop research studies with common research designs (1 site in each Bangladesh and Pakistan and a multicentre site in Democratic Republic of Congo, Kenya and Nigeria) and oversight mechanisms to evaluate antibiotic regimens (when referral is not accepted by the family) that are safe and efficacious, appropriate to the severity of infection, and deployable on a large scale and 3) utilize existing program delivery structures incorporating community health workers, skilled health workers to deliver simple antibiotic treatment when referral is not possible.Conclusions:This research program facilitated innovative research in different geographical, cultural and administrative milieus to generate recommendations for policy.

Safety and Efficacy of Simplified Antibiotic Regimens for Outpatient Treatment of Serious Infection in Neonates and Young Infants 0–59 Days of Age in Bangladesh

Background:Because access to care is limited in settings with high mortality, exclusive reliance on the current recommendation of 7–10 days of parenteral antibiotic treatment is a barrier to provision of adequate treatment of newborn infections.Methods:We are conducting a trial to determine if simplified antibiotic regimens with fewer injections are as efficacious as the standard course of parenteral antibiotics for empiric treatment of young infants with clinical signs suggestive of severe infection in 4 urban hospitals and in a rural surveillance site in Bangladesh. The reference regimen of intramuscular procaine-benzyl penicillin and gentamicin given once daily for 7 days is being compared with (1) intramuscular gentamicin once daily and oral amoxicillin twice daily for 7 days and (2) intramuscular penicillin and gentamicin once daily for 2 days followed by oral amoxicillin twice daily for additional 5 days. All regimens are provided in the infant’s home. The primary outcome is treatment failure (death or lack of clinical improvement) within 7 days of enrolment. The sample size is 750 evaluable infants enrolled per treatment group, and results will be reported at the end of 2013.Discussion:The trial builds upon previous studies of community case management of clinical severe infections in young infants conducted by our research team in Bangladesh. The approach although effective was not widely accepted in part because of feasibility concerns about the large number of injections. The proposed research that includes fewer doses of parenteral antibiotics if shown efficacious will address this concern.