SENTINEL1: The largest study to date of US preterm infants 29-35 wGA hospitalized with laboratory-confirmed RSV disease during the 2014-2015 and 2015-2016 RSV seasons1-3  

SENTINEL1 identified 1378 infants with community-acquired RSV across both the 2014-2015 and 2015-2016 RSV seasons from 46 hospitals*

Participating hospitals listed in tab below.

*Data were collected from October 1, 2014 through April 30, 2015, and October 1, 2015 through April 30, 2016; results represent data of eligible infants with an RSV-confirmed hospitalization irrespective of enrollment status.

Out of a total of 1398 study-eligible infants identified, 20 who had nosocomial RSV disease were separately analyzed from the 1378 who had community-acquired RSV disease.

A multicenter, retrospective and prospective observational study of respiratory syncytial virus (RSV) hospitalizations among US infants born at 29-35 wGA not receiving immunoprophylaxis in the 2014-2015 and 2015-2016 RSV seasons. Infants born at 29-35 wGA (29 weeks, 0 days through 35 weeks, 6 days) who were hospitalized ≥24 hours for laboratory-confirmed RSV disease (index RSVH) that was either community-acquired or nosocomial RSV disease AND who were <12 months of age at the time of index RSVH were included in the study.

Study Objectives

  • Characterize RSV-confirmed hospitalization among US preterm infants born at 29-35 wGA who had not received immunoprophylaxis during the 2014-2015 and 2015-2016 RSV seasons
  • Compare the 2015-2016 season results for the study-eligible identified patient population to those of the 2014-2015 season

 

In the 2014-2015 RSV season, average hospital and ICU length of stay was high and ranged from 7-10 days*

AVERAGE HOSPITAL LOS
Gestational age Mean hospital LOS, days (SD) Range
29-32 wGA
(n=237)
10 (10) 1-67
33-34 wGA
(n=283)
9 (12) 1-101
35 wGA
(n=182)
7 (11) 1-135
ICU LOS
Gestational age Mean ICU LOS, days (SD) Range
29-32 wGA
(n=115)
9 (8) 1-61
33-34 wGA
(n=117)
9 (12) 1-91
35 wGA
(n=56)
8 (9) 1-59

*702 infants 29-35 wGA hospitalized for community-acquired RSV disease were identified; hospital LOS data were available for 678 of the 702 infants. 288 of the 702 infants were admitted to the ICU; ICU LOS was available for 284 of these infants.

wGA=weeks gestational age; SD=standard deviation.

In the 2015-2016 RSV season, average hospital and ICU length of stay was high and ranged from 7-10 days

AVERAGE HOSPITAL LOS
Gestational age Mean hospital LOS, days (SD) Range
29-32 wGA
(n=204)
10 (16) 1-188
33-34 wGA
(n=288)
8 (10) 1-85
35 wGA
(n=184)
8 (11) 1-113
ICU LOS
Gestational age Mean ICU LOS, days (SD) Range
29-32 wGA
(n=97)
9 (9) 1-50
33-34 wGA
(n=136)
9 (8) 1-48
35 wGA
(n=88)
7 (8) 1-59

676 infants 29-35 wGA hospitalized for community-acquired RSV disease were identified; hospital LOS data were available for 674 of the 676 infants. 322 of the 676 infants were admitted to the ICU; ICU LOS was available for 321 of these infants.

wGA=weeks gestational age; SD=standard deviation.

In the 2014-2015 RSV season, RSV-confirmed hospitalizations were most frequent in infants <6 months of age1,2

The percentage of RSV-confirmed hospitalizations that occurred in those who were <6 months of age was:

78% for the total group (n=702)

  • 75% for infants 29-32 wGA (n=237)
  • 79% for infants 33-34 wGA (n=283)
  • 80% for infants 35 wGA (n=182)

In the 2015-2016 RSV season, RSV-confirmed hospitalizations were most frequent in infants <6 months of age1,2

The percentage of RSV-confirmed hospitalizations that occurred in those who were <6 months of age was:

78% for the total group (n=676)

  • 75% for infants 29-32 wGA (n=204)
  • 80% for infants 33-34 wGA (n=288)
  • 78% for infants 35 wGA (n=184)

In season 1, the 2014-2015 RSV season, RSV-confirmed ICU admission and need for invasive mechanical ventilation occurred more frequently in infants born at an earlier GA

 

Chronological age (CA)

Among the 29-32 wGA infants, 49% were admitted to the ICU and 24% required invasive mechanical ventilation

Among the 702 infants identified during the 2014-2015 season, hospital LOS data were available for 678 infants; data pertaining to ICU admission status and need for IMV were available for 684 infants.

In season 1, the 2014-2015 RSV season, RSV-confirmed ICU admission occurred more frequently in infants born at an earlier GA and <3 months of age

 

Proportion of infants who required ICU admission

Chronological age (CA)

68% of infants 29-32 wGA were admitted to the ICU when hospitalized at <3 months of age

 

In season 1, the 2014-2015 RSV season, the need for invasive mechanical ventilation occurred more frequently in infants <3 months of age

Proportion of infants who required invasive mechanical ventilation

Chronological age (CA)

44% of infants 29-32 wGA required invasive mechanical ventilation when hospitalized at <3 months of age

During season 2, the 2015-2016 RSV season, ICU admission and need for mechanical ventilation were consistent across all GA groups

 

Among the 29-32 wGA infants, 48% were admitted to the ICU and 20% required invasive mechanical ventilation

During the 2015-2016 season, 678 infants were identified, hospital LOS data were available for 676 infants; for Season 2, data pertaining to ICU admission status were available for 678 infants, whereas data pertaining to need for IMV were available for 677 infants.

§Among the 288 33-34 wGA infants identified in 2015-2016, data pertaining to need for invasive mechanical ventilation were available for 287 infants.

During season 2, the 2015-2016 RSV season, ICU admission continued to occur more frequently in infants with younger chronologic age

 

Proportion of infants who required ICU admission

Chronological age (CA)

70% of infants 29-32 wGA were admitted to the ICU when hospitalized at <3 months of age

During season 2, the 2015-2016 RSV season, the need for invasive mechanical ventilation continued to occur more frequently in infants with younger chronologic age

 

Proportion of infants who required invasive mechanical ventilation

Chronological age (CA)

37% of infants 29-32 wGA required invasive mechanical ventilation when hospitalized at <3 months of age

SENTINEL1 conclusions are:

  • Earlier gestational age and younger CA were associated with higher risk of RSV hospitalization
  • Younger CA (<3 months) was associated with a higher risk of ICU admission and need for IMV, which was consistent in both seasons
Consistent trends seen in the 2014–2015 and 2015–2016 RSV seasons confirm that the risks of RSV–related hospitalizations remain and should be considered when identifying infants who are at high risk for severe RSV disease
  1. Anderson EJ, DeVincenzo JP, Checchia PA, et al [poster #1279]. Presented at: IDWeek; October 26-30, 2016; New Orleans, LA.

  2. Data on file, Sobi, Inc. 

  3. Data on file, Sobi, Inc. 

 

Akron Children’s Hospital; Akron, OH

All Children’s Hospital Johns Hopkins Medicine; St. Petersburg, FL

Ann & Robert H. Lurie Children’s Hospital; Chicago, IL

Arkansas Children’s Hospital Research Institute; Little Rock, AR

Arnold Palmer Hospital for Children; Orlando, FL

AtlantiCare Regional Medical Center; Atlantic City, NJ

Boston Medical Center; Boston, MA

Children’s Hospital at Montefiore; Bronx NY

Children’s Hospital Colorado; Aurora, CO

Children’s Hospital Los Angeles; Los Angeles, CA

Children’s Hospital of Oklahoma City; Oklahoma City, OK

Children’s Hospital of Orange County; Orange, CA

Cincinnati Children’s Hospital; Cincinnati, OH

Columbia University Medical Center; New York, NY

Connecticut Children’s Medical Center; Hartford, CT

Dayton Children’s Hospital; Dayton, OH

Duke University Medical Center; Durham, NC

East Carolina University; Greenville, NC

Emory Children’s Center; Atlanta, GA

Evanston Hospital-NorthShore University HealthSystem; Evanston, IL

Florida Hospital for Children; Orlando, FL

Goryeb Children’s Hospital; Morristown, NJ

Kosair Children’s Hospital; Louisville, KY

Le Bonheur Children’s Hospital; Memphis, TN

Loma Linda University Children’s Hospital; Loma Linda, CA

Marshfield Clinic; Marshfield, WI

Medical University of South Carolina; Charleston, SC

MetroHealth Medical Center; Cleveland, OH

Miller Children’s & Women’s Hospital; Long Beach, CA

Ochsner Hospital for Children; New Orleans, LA

Penn State Hershey Children’s Hospital; Hershey, PA

Renown Regional Medical Center; Reno, NV

Sanford Children’s Specialty Clinic; Sioux Falls, SD

St. Joseph’s Children’s Hospital; Paterson, NJ

SUNY Downstate Medical Center; Brooklyn, NY

SUNY Upstate Medical University; Syracuse, NY

Texas Children’s Hospital; Houston, TX

University of Mississippi Medical Center; Jackson, MS

UMass Memorial Healthcare; Worcester, MA

University of Kansas Medical Center; Kansas City, KS

University of Rochester Medical Center; Rochester, NY

University of Texas Medical Branch; Galveston, TX

Vanderbilt University Medical Center; Nashville, TN

Virginia Commonwealth University Health System; Richmond, VA

WakeMed Health and Hospitals; Raleigh, NC

Winthrop University Hospital; Mineola, NY

SENTINEL1: The largest study to date of US preterm infants 29-35 wGA hospitalized with laboratory-confirmed RSV disease during the 2014-2015 and 2015-2016 RSV seasons1-3  

SENTINEL1 identified 1378 infants with community-acquired RSV across both the 2014-2015 and 2015-2016 RSV seasons from 46 hospitals*

Participating hospitals listed in tab below.

*Data were collected from October 1, 2014 through April 30, 2015, and October 1, 2015 through April 30, 2016; results represent data of eligible infants with an RSV-confirmed hospitalization irrespective of enrollment status.

Out of a total of 1398 study-eligible infants identified, 20 who had nosocomial RSV disease were separately analyzed from the 1378 who had community-acquired RSV disease.

A multicenter, retrospective and prospective observational study of respiratory syncytial virus (RSV) hospitalizations among US infants born at 29-35 wGA not receiving immunoprophylaxis in the 2014-2015 and 2015-2016 RSV seasons. Infants born at 29-35 wGA (29 weeks, 0 days through 35 weeks, 6 days) who were hospitalized ≥24 hours for laboratory-confirmed RSV disease (index RSVH) that was either community-acquired or nosocomial RSV disease AND who were <12 months of age at the time of index RSVH were included in the study.

Study Objectives

  • Characterize RSV-confirmed hospitalization among US preterm infants born at 29-35 wGA who had not received immunoprophylaxis during the 2014-2015 and 2015-2016 RSV seasons
  • Compare the 2015-2016 season results for the study-eligible identified patient population to those of the 2014-2015 season

 

In the 2014-2015 RSV season, average hospital and ICU length of stay was high and ranged from 7-10 days*

AVERAGE HOSPITAL LOS
Gestational age Mean hospital LOS, days (SD) Range
29-32 wGA
(n=237)
10 (10) 1-67
33-34 wGA
(n=283)
9 (12) 1-101
35 wGA
(n=182)
7 (11) 1-135
ICU LOS
Gestational age Mean ICU LOS, days (SD) Range
29-32 wGA
(n=115)
9 (8) 1-61
33-34 wGA
(n=117)
9 (12) 1-91
35 wGA
(n=56)
8 (9) 1-59

*702 infants 29-35 wGA hospitalized for community-acquired RSV disease were identified; hospital LOS data were available for 678 of the 702 infants. 288 of the 702 infants were admitted to the ICU; ICU LOS was available for 284 of these infants.

wGA=weeks gestational age; SD=standard deviation.

In the 2015-2016 RSV season, average hospital and ICU length of stay was high and ranged from 7-10 days

AVERAGE HOSPITAL LOS
Gestational age Mean hospital LOS, days (SD) Range
29-32 wGA
(n=204)
10 (16) 1-188
33-34 wGA
(n=288)
8 (10) 1-85
35 wGA
(n=184)
8 (11) 1-113
ICU LOS
Gestational age Mean ICU LOS, days (SD) Range
29-32 wGA
(n=97)
9 (9) 1-50
33-34 wGA
(n=136)
9 (8) 1-48
35 wGA
(n=88)
7 (8) 1-59

676 infants 29-35 wGA hospitalized for community-acquired RSV disease were identified; hospital LOS data were available for 674 of the 676 infants. 322 of the 676 infants were admitted to the ICU; ICU LOS was available for 321 of these infants.

wGA=weeks gestational age; SD=standard deviation.

In the 2014-2015 RSV season, RSV-confirmed hospitalizations were most frequent in infants <6 months of age1,2

The percentage of RSV-confirmed hospitalizations that occurred in those who were <6 months of age was:

78% for the total group (n=702)

  • 75% for infants 29-32 wGA (n=237)
  • 79% for infants 33-34 wGA (n=283)
  • 80% for infants 35 wGA (n=182)

In the 2015-2016 RSV season, RSV-confirmed hospitalizations were most frequent in infants <6 months of age1,2

The percentage of RSV-confirmed hospitalizations that occurred in those who were <6 months of age was:

78% for the total group (n=676)

  • 75% for infants 29-32 wGA (n=204)
  • 80% for infants 33-34 wGA (n=288)
  • 78% for infants 35 wGA (n=184)

In season 1, the 2014-2015 RSV season, RSV-confirmed ICU admission and need for invasive mechanical ventilation occurred more frequently in infants born at an earlier GA

 

Chronological age (CA)

Among the 29-32 wGA infants, 49% were admitted to the ICU and 24% required invasive mechanical ventilation

Among the 702 infants identified during the 2014-2015 season, hospital LOS data were available for 678 infants; data pertaining to ICU admission status and need for IMV were available for 684 infants.

In season 1, the 2014-2015 RSV season, RSV-confirmed ICU admission occurred more frequently in infants born at an earlier GA and <3 months of age

 

Proportion of infants who required ICU admission

Chronological age (CA)

68% of infants 29-32 wGA were admitted to the ICU when hospitalized at <3 months of age

 

In season 1, the 2014-2015 RSV season, the need for invasive mechanical ventilation occurred more frequently in infants <3 months of age

Proportion of infants who required invasive mechanical ventilation

Chronological age (CA)

44% of infants 29-32 wGA required invasive mechanical ventilation when hospitalized at <3 months of age

During season 2, the 2015-2016 RSV season, ICU admission and need for mechanical ventilation were consistent across all GA groups

 

Among the 29-32 wGA infants, 48% were admitted to the ICU and 20% required invasive mechanical ventilation

During the 2015-2016 season, 678 infants were identified, hospital LOS data were available for 676 infants; for Season 2, data pertaining to ICU admission status were available for 678 infants, whereas data pertaining to need for IMV were available for 677 infants.

§Among the 288 33-34 wGA infants identified in 2015-2016, data pertaining to need for invasive mechanical ventilation were available for 287 infants.

During season 2, the 2015-2016 RSV season, ICU admission continued to occur more frequently in infants with younger chronologic age

 

Proportion of infants who required ICU admission

Chronological age (CA)

70% of infants 29-32 wGA were admitted to the ICU when hospitalized at <3 months of age

During season 2, the 2015-2016 RSV season, the need for invasive mechanical ventilation continued to occur more frequently in infants with younger chronologic age

 

Proportion of infants who required invasive mechanical ventilation

Chronological age (CA)

37% of infants 29-32 wGA required invasive mechanical ventilation when hospitalized at <3 months of age

SENTINEL1 conclusions are:

  • Earlier gestational age and younger CA were associated with higher risk of RSV hospitalization
  • Younger CA (<3 months) was associated with a higher risk of ICU admission and need for IMV, which was consistent in both seasons
Consistent trends seen in the 2014–2015 and 2015–2016 RSV seasons confirm that the risks of RSV–related hospitalizations remain and should be considered when identifying infants who are at high risk for severe RSV disease
  1. Anderson EJ, DeVincenzo JP, Checchia PA, et al [poster #1279]. Presented at: IDWeek; October 26-30, 2016; New Orleans, LA.

  2. Data on file, Sobi, Inc. 

  3. Data on file, Sobi, Inc. 

 

Akron Children’s Hospital; Akron, OH

All Children’s Hospital Johns Hopkins Medicine; St. Petersburg, FL

Ann & Robert H. Lurie Children’s Hospital; Chicago, IL

Arkansas Children’s Hospital Research Institute; Little Rock, AR

Arnold Palmer Hospital for Children; Orlando, FL

AtlantiCare Regional Medical Center; Atlantic City, NJ

Boston Medical Center; Boston, MA

Children’s Hospital at Montefiore; Bronx NY

Children’s Hospital Colorado; Aurora, CO

Children’s Hospital Los Angeles; Los Angeles, CA

Children’s Hospital of Oklahoma City; Oklahoma City, OK

Children’s Hospital of Orange County; Orange, CA

Cincinnati Children’s Hospital; Cincinnati, OH

Columbia University Medical Center; New York, NY

Connecticut Children’s Medical Center; Hartford, CT

Dayton Children’s Hospital; Dayton, OH

Duke University Medical Center; Durham, NC

East Carolina University; Greenville, NC

Emory Children’s Center; Atlanta, GA

Evanston Hospital-NorthShore University HealthSystem; Evanston, IL

Florida Hospital for Children; Orlando, FL

Goryeb Children’s Hospital; Morristown, NJ

Kosair Children’s Hospital; Louisville, KY

Le Bonheur Children’s Hospital; Memphis, TN

Loma Linda University Children’s Hospital; Loma Linda, CA

Marshfield Clinic; Marshfield, WI

Medical University of South Carolina; Charleston, SC

MetroHealth Medical Center; Cleveland, OH

Miller Children’s & Women’s Hospital; Long Beach, CA

Ochsner Hospital for Children; New Orleans, LA

Penn State Hershey Children’s Hospital; Hershey, PA

Renown Regional Medical Center; Reno, NV

Sanford Children’s Specialty Clinic; Sioux Falls, SD

St. Joseph’s Children’s Hospital; Paterson, NJ

SUNY Downstate Medical Center; Brooklyn, NY

SUNY Upstate Medical University; Syracuse, NY

Texas Children’s Hospital; Houston, TX

University of Mississippi Medical Center; Jackson, MS

UMass Memorial Healthcare; Worcester, MA

University of Kansas Medical Center; Kansas City, KS

University of Rochester Medical Center; Rochester, NY

University of Texas Medical Branch; Galveston, TX

Vanderbilt University Medical Center; Nashville, TN

Virginia Commonwealth University Health System; Richmond, VA

WakeMed Health and Hospitals; Raleigh, NC

Winthrop University Hospital; Mineola, NY