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Modeling the Potential Impact of the 2014 American Academy of Pediatrics Respiratory Syncytial Virus Prophylaxis Guidance on Preterm Infant RSV Outcomes.

ABSTRACT: INTRODUCTION:The American Academy of Pediatrics (AAP) Committee on Infectious Diseases issued updated guidance on respiratory syncytial virus (RSV) prophylaxis in 2014. This report models the potential impact of the new guidance on RSV outcomes in preterm infants 29-34 weeks' gestational age (wGA) without chronic lung disease in the United States. METHODS:The number of preterm infants was estimated using 2012 natality data. Palivizumab utilization prior to the 2014 guidance update was estimated using 2013-2014 specialty pharmacy utilization data. Low, moderate, and high RSV hospitalization (RSVH) rates as well as average hospital length of stay, intensive care unit (ICU) admissions and mechanical ventilation (MV) frequencies were derived from published observational studies. Palivizumab efficacy was derived from two randomized clinical trials. RSV events that would be attributable to the 2014 guidance change were calculated for preterm infants 29-31 and 32-34 wGA. RESULTS:Annual number of infants 29-34 wGA surviving the neonatal period was estimated at 123,687. Of these, an estimated 44,712 (37%) would receive palivizumab based on the 2012 guidance. The annual number of RSVH among infants 29-34 wGA would increase from 3580 under the 2012 guidance to 6166 under the 2014 guidance based on moderate rates. This would result in an additional 24,440 hospitalization days, 1162 ICU admissions, and 584 MV events among this population. CONCLUSIONS:Based on published historical and contemporary data on RSVH rates in preterm infants 29-34 wGA, the 2014 AAP guidance is expected to result in additional burden to the healthcare system and families of preterm infants. The impact of the new guidance will be difficult to detect among the overall infant population, particularly in settings without routine testing for RSV, but the impact will be substantial for the small high-risk population affected by the changes. FUNDING:AstraZeneca.

SUBMITTER: McLaurin KK

PROVIDER: S-EPMC4675761 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Respiratory syncytial virus (RSV) is a public health concern that causes acute lower respiratory tract infection. So far, no vaccine candidate under development has reached the market and the only licensed product to prevent RSV infection in at-risk infants and young children is a monoclonal antibody (Synagis®). Polyclonal human anti-RSV hyper-immune immunoglobulins (Igs) have also been used but were superseded by Synagis® owing to their low titer and large infused volume. Here we report a new drug class of immunoglobulins, derived from human non hyper-immune plasma that was generated by an innovative bioprocess, called Ig cracking, combining expertises in plasma-derived products and affinity chromatography. By using the RSV fusion protein (F protein) as ligand, the Ig cracking process provided a purified and concentrated product, designated hyper-enriched anti-RSV IgG, composed of at least 15-20% target-specific-antibodies from normal plasma. These anti-RSV Ig displayed a strong in vitro neutralization effect on RSV replication. Moreover, we described a novel prophylactic strategy based on local nasal administration of this unique hyper-enriched anti-RSV IgG solution using a mouse model of infection with bioluminescent RSV. Our results demonstrated that very low doses of hyper-enriched anti-RSV IgG can be administered locally to ensure rapid and efficient inhibition of virus infection. Thus, the general hyper-enriched Ig concept appeared a promising approach and might provide solutions to prevent and treat other infectious diseases.ImportanceRespiratory Syncytial Virus (RSV) is the major cause of acute lower respiratory infections in children, and is also recognized as a cause of morbidity in the elderly. There are still no vaccines and no efficient antiviral therapy against this virus. Here, we described an approach of passive immunization with a new class of hyper-enriched anti-RSV immunoglobulins (Ig) manufactured from human normal plasma. This new class of immunoglobulin plasma derived product is generated by an innovative bioprocess, called Ig cracking, which requires a combination of expertise in both plasma derived products and affinity chromatography. The strong efficacy in a small volume of these hyper-enriched anti-RSV IgG to inhibit the viral infection was demonstrated using a mouse model. This new class of immunoglobulin plasma-derived products could be applied to other pathogens to address specific therapeutic needs in the field of infectious diseases or even pandemics, such as COVID-19.

Project description:BackgroundWith the increasing integration of technology into society, it is advisable that researchers explore the effects of repeated digital media exposure on our most vulnerable population-infants. Excessive screen time during infancy has been linked to delays in language, literacy, and self-regulation.ObjectiveThis study explores the awareness of and adherence to the American Academy of Pediatrics' (AAP) recommendations related to avoiding screen time for infants younger than 2 years and the motivational factors associated with screen time exposure.MethodsA mixed methods survey design was used to gather responses from 178 mothers of infants younger than 2 years. The measures included infant screen time use and duration, maternal awareness of screen time use recommendations, and motivations related to screen time exposure. A variety of statistical procedures were used to explore associations between caregiver awareness of and adherence to AAP guidelines for screen time exposure, motivations related to screen time for infants, and the duration of infant screen time exposure.ResultsThe results indicated that 62.2% (111/178) of mothers were aware of the AAP screen time recommendations, but only 46.1% (82/178) could cite them accurately, and most mothers learned of them via the internet or from a medical professional. Mothers who were aware of the guidelines allowed significantly less screen time for infants than those who were unaware (P=.03). In addition, parents who adhered to the AAP guidelines reported significantly less infant screen time per day than those who did not adhere (P<.001). Among mothers who reported not adhering to the guidelines, the greatest motivation for allowing screen time was perceived educational benefits. Less educated mothers rated an infant's relaxation as a motivational factor in allowing screen time significantly higher than more highly educated mothers (P=.048). The regression analysis indicated that none of the parental motivation factors predicted daily infant screen time.ConclusionsThese results indicate 2 key approaches to improving adherence to screen time recommendations. First, the awareness of the AAP recommendations needs to be increased, which tends to improve adherence. Second, the myth that screen time can be educational for infants needs to be dispelled.

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Modeling the Potential Impact of the 2014 American Academy of Pediatrics Respiratory Syncytial Virus Prophylaxis Guidance on Preterm Infant RSV Outcomes.

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