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Influenza Among Young Children in Bangladesh: Clinical Characteristics and Outcomes From a Randomized Clinical Trial.

ABSTRACT: Influenza causes substantial morbidity in children worldwide, although influenza vaccine is seldom used in low-resource settings. More information on the clinical presentation of influenza and the efficacy of vaccine is needed to inform policy.In 2013 we conducted a randomized, placebo-controlled clinical trial of live attenuated influenza vaccine (LAIV) in children aged 24-59 months in Bangladesh (N = 1761). If participants met prespecified specimen collection criteria, we collected nasopharyngeal washes for testing by singleplex reverse-transcription polymerase chain reaction (RT-PCR) for laboratory-confirmed influenza virus infection (LCI). A panel of RT-PCR assays was used to detect noninfluenza respiratory viruses. Primary efficacy results have been reported. In this analysis of prespecified and post hoc objectives from the trial, we compared signs and symptoms between LCI and non-LCI cases and estimated the efficacy of LAIV against moderate-to-severe LCI and other prespecified non-LCI clinical outcomes including all-cause pneumonia and acute otitis media.The most common signs and symptoms of LCI were fever, cough, and runny nose. The combination of subjective fever and cough had a 63% sensitivity for LCI. The combination of measured fever, cough, and runny nose was most specific (90%) but had low sensitivity (32%) for LCI. The efficacy of LAIV against vaccine-strain moderate-to-severe LCI was 56.7% (95% confidence interval, 9.5%-79.2%). No statistically significant vaccine efficacy was found against the non-laboratory-confirmed clinical outcomes.It was not possible to distinguish LCI from noninfluenza viral infections on clinical evaluations alone in this population of Bangladeshi children. LAIV was efficacious against moderate-to-severe LCI.NCT01797029.

SUBMITTER: Rotrosen E

PROVIDER: S-EPMC5850015 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Influenza Among Young Children in Bangladesh: Clinical Characteristics and Outcomes From a Randomized Clinical Trial.

Rotrosen Elizabeth E Zaman K K Feser Jodi J Ortiz Justin R JR Goswami Doli D Sharmeen Amina Tahia AT Rahman Mustafizur M Lewis Kristen D C KDC Rahman Md Ziaur MZ Barin Burc B Brooks W Abdullah WA Neuzil Kathleen M KM

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20171101 11

<h4>Background</h4>Influenza causes substantial morbidity in children worldwide, although influenza vaccine is seldom used in low-resource settings. More information on the clinical presentation of influenza and the efficacy of vaccine is needed to inform policy.<h4>Methods</h4>In 2013 we conducted a randomized, placebo-controlled clinical trial of live attenuated influenza vaccine (LAIV) in children aged 24-59 months in Bangladesh (N = 1761). If participants met prespecified specimen collection ...[more]

PMID: 29028980

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Project description:BackgroundFew trials have evaluated influenza vaccine efficacy (VE) in young children, a group particularly vulnerable to influenza complications. We aimed to estimate VE against influenza in children aged <2 years in Bangladesh; a subtropical setting, where influenza circulation can be irregular.MethodsChildren aged 6-23 months were enrolled 1:1 in a parallel, double-blind, randomized controlled trial of trivalent inactivated influenza vaccine (IIV3) versus inactivated polio vaccine (IPV); conducted August 2010-March 2014 in Dhaka, Bangladesh. Children received two pediatric doses of vaccine, one month apart, and were followed for one year for febrile and respiratory illness. Field assistants conducted weekly home-based, active surveillance and ill children were referred to the study clinic for clinical evaluation and nasopharyngeal wash specimen collection. Analysis included all children who received a first vaccine dose and compared yearly incidence of reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza between trial arms. The VE was estimated as 1-(rate ratio of illness) × 100%, using unadjusted Poisson regression. The trial was registered with ClinicalTrials.gov, number NCT01319955.ResultsAcross four vaccination rounds, 4081 children were enrolled and randomized, contributing 2576 child-years of observation to the IIV3 arm and 2593 child-years to the IPV arm. Influenza incidence was 10 episodes/100 child-years in the IIV3 arm and 15 episodes/100 child-years in the IPV arm. Overall, the VE was 31% (95% confidence interval 18, 42%) against any RT-PCR-confirmed influenza. The VE varied by season, but was similar by influenza type/subtype and participant age and sex.ConclusionsVaccination of young children with IIV3 provided a significant reduction in laboratory-confirmed influenza; however, exploration of additional influenza vaccine strategies, such as adjuvanted vaccines or standard adult vaccine doses, is warranted to find more effective influenza vaccines for young children in low-income countries.

Project description:ImportanceEmphasizing sun protection behaviors among young children may minimize sun damage and foster lifelong sun protection behaviors that will reduce the likelihood of developing skin cancer, especially melanoma.ObjectiveTo determine whether a multicomponent sun protection program delivered in pediatric clinics during the summer could increase summertime sun protection among young children.Design, setting, and participantsRandomized controlled clinical trial with 4-week follow-up that included 300 parents or relatives (hereafter simply referred to as caregivers [mean age, 36.0 years]) who brought the child (2-6 years of age) in their care to an Advocate Medical Group clinic during the period from May 15 to August 14, 2015. Of the 300 caregiver-child pairs, 153 (51.0%) were randomly assigned to receive a read-along book, swim shirt, and weekly text-message reminders related to sun protection behaviors (intervention group) and 147 (49.0%) were randomly assigned to receive the information usually provided at a well-child visit (control group). Data analysis was performed from August 20 to 30, 2015.InterventionMulticomponent sun protection program composed of a read-along book, swim shirt, and weekly text-message reminders related to sun protection behaviors.Main outcomes and measuresOutcomes were caregiver-reported use of sun protection by the child (seeking shade and wearing sun-protective clothing and sunscreen) using a 5-point Likert scale, duration of outdoor activities, and number of children who had sunburn or skin irritation. The biologic measurement of the skin pigment of a child's arm was performed with a spectrophotometer at baseline and 4 weeks later.ResultsOf the 300 caregiver-child pairs, the 153 children in the intervention group had significantly higher scores related to sun protection behaviors on both sunny (mean [SE], 15.748 [0.267] for the intervention group; mean [SE], 14.780 [0.282] for the control group; mean difference, 0.968) and cloudy days (mean [SE], 14.286 [0.282] for the intervention group; mean [SE], 12.850 [0.297] for the control group; mean difference, 1.436). Examination of pigmentary changes by spectrophotometry revealed that the children in the control group significantly increased their melanin levels, whereas the children in the intervention group did not have a significant change in melanin level on their protected upper arms (P < .001 for skin type 1, P = .008 for skin type 2, and P < .001 for skin types 4-6).Conclusions and relevanceA multicomponent intervention using text-message reminders and distribution of read-along books and swim shirts was associated with increased sun protection behaviors among young children. This was corroborated by a smaller change in skin pigment among children receiving the intervention. This implementable program can help augment anticipatory sun protection guidance in pediatric clinics and decrease children's future skin cancer risk.Trial registrationclinicaltrials.gov Identifier: NCT02376517.

Project description:ImportanceEarly behavior problems in children with developmental delay (DD) are prevalent and impairing, but service barriers persist. Controlled studies examining telehealth approaches are limited, particularly for children with DD.ObjectiveTo evaluate the efficacy of a telehealth parenting intervention for behavior problems in young children with DD.Design, setting, and participantsA randomized clinical trial was conducted from March 17, 2016, to December 15, 2020, in which children with DD and externalizing behavior problems were recruited from early intervention and randomly assigned to a telehealth parenting intervention or control group and evaluated through a 12-month follow-up. Most children were from ethnic or racial minoritized backgrounds. Over one-half of children were in extreme poverty or low income-need ratio categories.InterventionsInternet-delivered parent-child interaction therapy (iPCIT), which leverages videoconferencing to provide live coaching of home-based caregiver-child interactions. Families received 20 weeks of iPCIT (provided in English or in Spanish) or referrals as usual (RAU).Main outcomes and measuresObservational and caregiver-report measures of child and caregiver behaviors and caregiving stress were examined at preintervention, midtreatment, and postintervention and at 6- and 12-month follow-ups.ResultsThe sample included a total of 150 children (mean [SD] age, 36.2 [1.0] months; 111 male children [74%]) and their caregivers with 75 each randomly assigned to iPCIT or RAU groups. Children receiving iPCIT relative to RAU displayed significantly lower levels of externalizing problems (postintervention Cohen d = 0.48; 6-month Cohen d = 0.49; 12-month Cohen d = 0.50) and significantly higher levels of compliance to caregiver direction after treatment. Of those children with data at postintervention, greater clinically significant change was observed at postintervention for children in the iPCIT group (50 [74%]) than for those in the RAU group (30 [42%]), which was maintained at the 6-month but not the 12-month follow-up. iPCIT did not outperform RAU in reducing caregiving stress, but caregivers receiving iPCIT, relative to RAU, showed steeper increases in proportion of observed positive parenting skills (postintervention odds ratio [OR], 1.10; 95% CI, 0.53-2.21; 6-month OR, 1.31; 95% CI, 0.61-2.55; 12-month OR, 1.64; 95% CI, 0.70-3.07) and sharper decreases in proportion of observed controlling/critical behaviors (postintervention OR, 1.40; 95% CI, 0.61-1.52; 6-month OR, 1.72; 95% CI, 0.58-1.46; 12-month OR, 2.23; 95% CI, 0.53-1.37). After treatment, iPCIT caregivers also self-reported steeper decreases in harsh and inconsistent discipline than did than RAU caregivers (postintervention Cohen d = 0.24; 6-month Cohen d = 0.26; 12-month Cohen d = 0.27).Conclusions and relevanceResults of this randomized clinical trial provide evidence that a telehealth-delivered parenting intervention with real-time therapist coaching led to significant and maintained improvements for young children with DD and their caregivers. Findings underscore the promise of telehealth formats for expanding scope and reach of care for underserved families.Trial registrationClinicalTrials.gov Identifier: NCT03260816.

Dataset Information

Influenza Among Young Children in Bangladesh: Clinical Characteristics and Outcomes From a Randomized Clinical Trial.

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Influenza Among Young Children in Bangladesh: Clinical Characteristics and Outcomes From a Randomized Clinical Trial.

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