Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants

Sponsor

MedImmune LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00384462

Collaborator

(none)

346

Enrollment

Locations

Duration (Months)

5.9

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to describe respiratory syncytial virus (RSV) hospitalization rates and to begin to address the utilization of outpatient resources for RSV medically-attended lower respiratory tract infections (MALRI) in 32-35 week gestational age (GA) premature infants who are less than 6 months of age and do not receive treatment.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infections

Detailed Description

The goals of this study are:

To estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants who are:
32-35 weeks GA
less than 6 months of age at the start of the RSV season
not receiving palivizumab prophylaxis and not recommended to receive palivizumab according to the AAP guidelines
To estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations and time periods (e.g., Cohort 2, Cohorts 1 and 2 combined, and subgroups based on chronological age at the start of the RSV season, GA, etc. within 150 days from enrollment and other time periods based on RSV activity, etc.)
To estimate the incidence of RSV-associated MALRI in the study populations
To characterize the incidence and type of clinical interventions for MALRI in the study populations

Study Design

Study Type:

Observational

Actual Enrollment :

346 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective, Non-Interventional Study to Evaluate the Incidence of Hospitalizations and Medically-Attended Lower Respiratory Tract Infection (MALRI) in Premature Infants 32 to 35 Weeks Gestational Age Who Are Not Recommended to Receive Prophylaxis for RSV

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
1 Premature Infants (32-35 wks. GA) who are less than six months of age at start of RSV season and followed until May of the following year.
2 Premature newborns (32-35 wks. GA) who are born during the current RSV season and discharged from the hospital after 01 Dec and followed until May of the next year.

Outcome Measures

Primary Outcome Measures

Estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants [150 days from enrollment]

Secondary Outcome Measures

Estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations [150 days after enrollment]
Estimate the incidence rate of MALRI attributable to RSV in the study populations; [during follow up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 6 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Parent/legal guardian able to understand and provide written informed consent
Male or female infants born at 32-35 weeks GA. GA will be determined according to available medical records.
Clinically stable, in the opinion of the investigator
Ability and willingness of the subject's parent/legal guardian to complete all protocol mandated follow-up telephone calls, visits and procedures
Not more than one of the following American Academy of Pediatrics (AAP)-defined risk factors:

Childcare attendance
School-aged siblings in the home
Exposure to environmental air pollutants (not including passive exposure to tobacco smoke)
Congenital abnormalities of the airways
Severe neuromuscular disease, as determined by the investigator

Subject must meet the criteria listed below for either Cohort 1 or Cohort 2:

Cohort 1

Date of enrollment between 01/Oct and 15/Dec
Chronological age of < 6 months (i.e., has not yet reached 6-month birthday) at the traditional start of the local RSV season (as used to determine eligibility for RSV prophylaxis)

Cohort 2

Date of enrollment between 16/Dec and 15/Feb
Born during the current RSV season and discharged from the hospital nursery after 01/Dec

Exclusion Criteria:

Previous (within 90 days of enrollment) or concurrent treatment with palivizumab or RSV-IGIV or IVIG
Hospitalization at the time of enrollment (unless discharge is anticipated within 10 days)
Two or more AAP-defined risk factors as listed under Inclusion Criteria
Participation in trials of investigational RSV prophylaxis or therapeutic agents
Confirmed prior or current RSV infection (a child with current signs/symptoms of respiratory infection must have negative RSV testing)
Diagnosis of chronic lung disease (CLD) of prematurity (formerly referred to as bronchopulmonary dysplasia [BPD])
Diagnosis of hemodynamically significant congenital heart disease (CHD), defined as requiring medication or supplemental oxygen for their CHD
Known immunodeficiency
Life expectancy of < 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Central Arkansas Pediatric Clinic, P.A.	Benton	Arkansas	United States	72019
3	The Children's Clinic of Jonesboro, P.A.	Jonesboro	Arkansas	United States	72401
4	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas	United States	72205
5	Arkansas Pediatric Clinic	Little Rock	Arkansas	United States	72205
6	Little Rock Children's Clinic	Little Rock	Arkansas	United States	72205
7	Miller Children's Hospital	Long Beach	California	United States	90806
8	Children's Hospital of Oakland	Oakland	California	United States	94609
9	Children's Hospital of Orange County	Orange	California	United States	92868
10	Children's Hospital	Denver	Colorado	United States	82018
11	Pediatric Pulmonology, LLC	Stamford	Connecticut	United States	06902
12	Shands Hospital at the University of Florida	Gainesville	Florida	United States	32610
13	University of Miami Medical Center	Miami	Florida	United States	33136
14	University of South Florida Pediatrics Ambulatory Care Center	Tampa	Florida	United States	33136
15	Georgia Pediatric Pulmonology Associates	Atlanta	Georgia	United States	30342
16	Kapiolani Medical Center	Honolulu	Hawaii	United States	96826
17	University of Illinois at Chicago	Chicago	Illinois	United States	60612
18	Children's Memorial Hospital	Chicago	Illinois	United States	60614
19	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
20	University of Maryland, School of Medicine	Baltimore	Maryland	United States	21201
21	Tufts-New England Medical Center	Boston	Massachusetts	United States	02111
22	Boston Medical Center	Boston	Massachusetts	United States	02118
23	Children's Healthcare D.B.A. Hospitals & Clinics	St. Paul	Minnesota	United States	55102
24	Pediatrix Medical Group, St. John's Mercy Medical Center	St. Louis	Missouri	United States	63141
25	Midwest Children's Health Research Institute, LLC	Lincoln	Nebraska	United States	68505
26	Creighton University Medical Center	Omaha	Nebraska	United States	68198
27	Albany Medical Center	Albany	New York	United States	12208
28	Bronx-Lebanon Hospital Center	Bronx	New York	United States	10457
29	Jacobi Medical Center	Bronx	New York	United States	10461
30	Montefiore Medical Center	Bronx	New York	United States	10467
31	Winthrop University Hospital	Mineola	New York	United States	11501
32	University of Rochester Medical Center	Rochester	New York	United States	14624
33	University Hospital, State University of New York at Stony Brook	Stony Brook	New York	United States	11794
34	Crouse Hospital NICU	Syracuse	New York	United States	13210
35	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
36	Duke University Medical Center	Durham	North Carolina	United States	27710
37	Raleigh Pediatric Associates	Gardner	North Carolina	United States	27529
38	Raleigh Pediatric Associates	Raleigh	North Carolina	United States	27615
39	Children's Hospital Medical Center of Akron	Akron	Ohio	United States	44308
40	Beehly Medical Park Women's and Children's Pavilion	Boardman	Ohio	United States	44512
41	University of Cincinnati College of Medicine	Cincinnati	Ohio	United States	45267
42	Metro Health Medical Center	Cleveland	Ohio	United States	44109
43	Children's Medical Center	Dayton	Ohio	United States	45404
44	Pediatric Associates of Dayton, Inc.	Kettering	Ohio	United States	45429
45	St. Vincent Medical Center	Toledo	Ohio	United States	43608
46	Oregon Health & Science University	Portland	Oregon	United States	97239
47	St. Luke's Hospital	Bethlehem	Pennsylvania	United States	18015
48	Geisinger Medical Center - JW Children's Hospital	Danville	Pennsylvania	United States	17822
49	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19017
50	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
51	Rhode Island Hospital	Providence	Rhode Island	United States	02903
52	Driscoll Children's Hospital	Corpus Christi	Texas	United States	78414
53	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
54	University of Texas Houston Medical Center	Houston	Texas	United States	77030
55	VCU Medical Center, Children's Pavillion	Richmond	Virginia	United States	23298
56	University Physicians Internal Medicine	Huntington	West Virginia	United States	25701
57	West Virginia University	Morgantown	West Virginia	United States	26506
58	Children's Hospital Waukesha Memorial	Waukesha	Wisconsin	United States	53118
59	Children's Corporate Center	Wauwatosa	Wisconsin	United States	53226