Thursday, 8 October 2015
SENTINEL1 Study Reveals Burden of Severe RSV Disease in Preterm Infants
In collaboration with physicians at 43 US hospitals, AstraZeneca today presented results from an ongoing observational study, SENTINEL1, at the IDWeek 2015 annual scientific meeting in San Diego, California. SENTINEL1 was designed to characterize RSV-confirmed hospitalizations among US preterm infants born at 29-35 weeks gestation who did not receive immunoprophylaxis during the 2014-2015 RSV season.1 In July 2014, new guidance was published that recommended against the use of immunoprophylaxis for respiratory syncytial virus (RSV) in preterm infants born at 29-35 weeks gestation who do not have chronic lung disease.2
The study results confirmed that among preterm infants 29-35 weeks gestation who did not receive immunoprophylaxis, RSV disease can be severe, often resulting in intensive care unit (ICU) admission and the need for mechanical ventilation (MV).1
“RSV disease is the most common serious infection preterm infants will face in the first months of life,” said lead investigator Dr. Leonard Krilov, pediatric infectious disease specialist, Winthrop-University Hospital. “The SENTINEL1 study confirms that preterm infants born at 29-35 weeks gestation commonly have serious complications when hospitalized with RSV disease.”1,3,4
The SENTINEL1 study collected data from 43 US hospitals from October 1, 2014, through April 30, 2015. In total, 709 RSV-confirmed hospitalizations were identified among eligible preterm infants born at 29-35 weeks gestation. SENTINEL1 represents the largest study ever conducted in the US of preterm infants hospitalized with laboratory-confirmed severe RSV disease.1
Among these hospitalized infants, 295 (42%) were admitted to the ICU and 140 (20%) required mechanical ventilation. Infants under six months of age accounted for the majority of RSV-confirmed hospitalizations (78%), ICU admissions (87%), and the need for MV (92%).1
Earlier gestational age and younger chronologic age were associated with a higher risk of RSV-confirmed ICU admissions and need for mechanical ventilation.1
- Among infants <3 months, 69% of infants 29-32 weeks gestation, 52% of infants 33-34 weeks gestation, and 38% of infants 35 weeks gestation were admitted to the ICU.1
- Among infants <3 months, 45% of infants 29-32 weeks gestation, 25% of infants 33-34 weeks gestation, and 19% of infants 35 weeks gestation required MV.1
- Adjusting for their prevalence in US births, RSV hospitalizations among infants 29–32 and 33–34 weeks gestation were 2.0-fold (95% CI: 1.6, 2.4) and 1.5-fold (95% CI: 1.2, 1.8) more frequent, respectively, than RSV hospitalizations among infants 35 weeks gestation.1
“The SENTINEL1 data adds significantly to the existing research on the risk of severe RSV disease in US preterm infants,” said Dr. Krilov. “It is my hope – and the hope of many concerned clinicians – that physicians carefully consider these data when identifying which of their preterm infants are at high risk for severe RSV disease during the upcoming RSV season.”
NOTES TO EDITORS
SENTINEL1 is an ongoing retrospective and prospective study aimed to characterize RSV-confirmed hospitalizations among US preterm infants born at 29-35 weeks gestation who did not receive immunoprophylaxis during the 2014-2015 RSV season.1 Initial results from the first season of the SENTINEL1 study are based on data of all identified eligible infants with RSV-confirmed hospitalizations, irrespective of enrollment status. The eligibility criteria for SENTINEL1 included infants who were <12 months of age at the time of RSV-confirmed hospitalization admission, and who had been hospitalized for ≥24 hours because of laboratory-confirmed RSV disease during the 2014–2015 RSV season. Eligible infants did not receive immunoprophylaxis within 35 days before the onset of RSV disease symptoms. SENTINEL1 evaluated gestational age and chronologic age, hospital length of stay (LOS), intensive care unit (ICU) admission, ICU LOS, and mechanical ventilation, and survival.1
RSV is a contagious, seasonal respiratory virus that nearly all children will contract by the age of two and most will recover from within 1-2 weeks.5,6,7 In certain high-risk babies, however, RSV can lead to a serious lung infection and hospitalization.6,7 Preterm infants are at increased risk of developing severe RSV disease because their lung volume is significantly less than that of full-term infants, and their airways are smaller and narrower than those of a baby born at term.8,9
IDWeek is the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca-us.com.
|Melissa Garcia (US)||+1 301 398 6470|
|Abigail Bozarth (US)||+1 302 885 2677|
1. Data on File, 3157304, AstraZeneca Pharmaceuticals LP.
2. American Academy of Pediatrics. Policy statement: updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014.
3. Winterstein AG, et al. Appropriateness of age thresholds for respiratory syncytial virus immunoprophylaxis in moderate-preterm infants: a cohort study. JAMA Pediatr. 2013;167:1118-1124.
4. Helfrich AM, et al. Healthy Late-preterm infants born 33–36 + 6 weeks gestational age have higher risk for respiratory syncytial virus hospitalization. Early Hum Dev. 2015;91:541-546.
5. Centers for Disease Control and Prevention. Infection and Incidence.http://www.cdc.gov/rsv/about/infection.html. Accessed June 26, 2015.
6. Hall CB, Weinberg GA, Iwane MK, et al. The Burden of Respiratory Syncytial Virus Infection in Young Children. N Engl J Med. 2009;360:588-598.
7. Boyce TG, et al. Rates of hospitalizations for respiratory syncytial virus infection among children in Medicaid. J Pediatr. 2000; 137:865-70.
8. Centers for Disease Control and Prevention. Premature Birth.http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm. Accessed June 26, 2015.
9. Langston C, Kida K, Reed M, Thurlbeck WM. Human lung growth in late gestation and in the neonate. Am Rev Respir Dis. 1984;129:607-613.