Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants - Full Text View

Sponsored by:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00384462

Purpose

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
Respiratory Syncytial Virus Infections

MedlinePlus related topics: Premature Babies Respiratory Syncytial Virus Infections

Drug Information available for: Palivizumab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants [ Time Frame: 150 days from enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations [ Time Frame: 150 days after enrollment ] [ Designated as safety issue: No ]
Estimate the incidence rate of MALRI attributable to RSV in the study populations; [ Time Frame: during follow up ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	343
Study Start Date:	October 2006
Study Completion Date:	May 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

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

Eligibility

Ages Eligible for Study:	1 Month to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

2 cohorts of premature infants and premature newborns 32-35 weeks

Criteria

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:
1. Childcare attendance
2. School-aged siblings in the home
3. Exposure to environmental air pollutants (not including passive exposure to tobacco smoke)
4. Congenital abnormalities of the airways
5. 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384462

Show 59 Study Locations

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:

Frank Malinoski, M.D., PhD

MedImmune LLC

More Information

Responsible Party:	MedImmune Inc. ( Frank Malinoski, M.D., PhD )
Study ID Numbers:	MI-MA140
Study First Received:	October 4, 2006
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00384462
Health Authority:	United States: Institutional Review Board

Keywords provided by MedImmune LLC:

Premature infants (32-35 weeks GA) <6 months of age at the start of the RSV season who are not receiving palivizumab and do not have CLD of prematurity
Respiratory Syncytial Viruses

Study placed in the following topic categories:

Virus Diseases
Paramyxoviridae Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Respiratory Syncytial Virus Infections
Palivizumab

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Pneumovirus Infections
Infection
Mononegavirales Infections

ClinicalTrials.gov processed this record on January 16, 2009