Compliance to Synagis (Palivizumab) Under Daily Pediatric... | NCT01077271 | Trialant
NCT01077271
Sponsor
Abbott
Status
Completed
Last Update Posted
Aug 21, 2012Estimated
Enrollment
124Actual
Phase
Not provided
Conditions
Premature Infants
Interventions
Not provided
Countries
Austria
Protocol Section
Identification Module
NCT ID
NCT01077271
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
P11-040
Secondary IDs
Not provided
Brief Title
Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA
Official Title
PMOS to Evaluate the Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA Over 3 Consecutive Respiratory Syncytial Virus (RSV) Seasons in Austria
Acronym
Not provided
Organization
AbbottINDUSTRY
Status Module
Record Verification Date
Aug 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2008
Primary Completion Date
May 2011Actual
Completion Date
May 2011Actual
First Submitted Date
Feb 25, 2010
First Submission Date that Met QC Criteria
Feb 25, 2010
First Posted Date
Mar 1, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
May 17, 2012
Results First Submitted that Met QC Criteria
Aug 20, 2012
Results First Posted Date
Aug 21, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 20, 2012
Last Update Posted Date
Aug 21, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbottINDUSTRY
Collaborators
Name
Class
Assign Data Management and Biostatistics GmbH
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Compliance to Synagis (palivizumab) is a key factor to obtain maximal protection against respiratory syncytial virus (RSV) infection as shown in the IMpact study. Many factors such as parents' knowledge of burden of respiratory syncytial virus disease or physicians' satisfaction with Synagis as well as the appropriate use of the product might influence compliance. The primary objective of this observational study is to evaluate the compliance to Synagis under daily pediatricians practice conditions in premature infants 33 to 35 weeks gestational age (wGA). Palivizumab, monoclonal antibody for passive immunoprophylaxis against severe respiratory syncytial virus disease, was administered according to usual clinical practice. Compliance was assessed using four criteria: The number of injections per participant per respiratory syncytial virus season, the body site where injections were administered, the interval in days between injections, and the dosage per administration. Originally the study was to include two respiratory syncytial virus seasons but was extended to a third season.
Detailed Description
Not provided
Conditions Module
Conditions
Premature Infants
Keywords
Premature infants
Respiratory Syncytial Virus (RSV)
Compliance
Palivizumab
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
124Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Premature infants 33 - 35 wGA prophylaxed with palivizumab
Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with Synagis (palivizumab)
Interventions
Not provided
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Injections Per Patient Per Season
The average number of injections administered per participant within a respiratory syncytial virus season.
One RSV season (5 months)
Body Site of Injections Per Administration
The body site of injection administration for participants at each study visit.
One RSV season (5 months)
Interval Between Administrations
The average number of days that elapsed between palivizumab injections administered at the previous study visit.
One RSV season (5 months)
Dosage Per Administration
The median dose and range of palivizumab (milligrams) that was administered at each study visit.
One RSV season (5 months)
Secondary Outcomes
Measure
Description
Time Frame
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
The clinician who administered the palivizumab injection was asked to rate pain during injection using a visual analog scale (VAS) and the Modified Behavior Pain Scale (MBPS) as published by Carbajal et al., 2008. The VAS ranged from 0 (no pain) to 100 (maximum pain). The Modified Behavioral Pain Scale ranged from 0 (no pain) to 10 (maximum pain) through the evaluation of 3 items: Facial expressions, cry, and movements. If more than one injection was given at a visit, then the first injection was rated.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Premature infant 33 to 35 weeks gestational age
Younger than 3 months at respiratory syncytial virus season start
At least 4 points according to the Austrian risk score according to Austrian guidelines: 1 point younger than 3 months (at start of respiratory syncytial virus season), 1 point neurologic disease, 1 point weight less than 10th percentile, 1 point discharge from hospital during respiratory syncytial virus season (1 Oct - 30 March), 1 point older siblings, 0.5 points multiple births, 0.5 points day care attendance, 0.5 points passive tobacco smoke exposure, 0.5 points socio-economic status (overcrowding)
Synagis application (prescription)
Signed authorization form for data use (parental authorization)
Exclusion Criteria:
Patients without Synagis prescription
Patients who meet contraindications as outlined in the latest version of Synagis summary of product characteristics (SmPC):
Patients with known hypersensitivity to palivizumab or any component of the formulation or other humanized monoclonal antibodies
Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab
Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Not provided
Intervention Model Description
Not provided
Primary Purpose
Not provided
Observational Model
Cohort
Time Perspective
Prospective
Masking Info
No data available
No data is available for this block.
One RSV season (5 months)
Parents Knowledge of Burden of RSV Disease Via Interview by Physician
An informational brochure was given to parents of participants. Parents were interviewed by the treating physician at the first study visit (V1) and last study visit (LSV) (or early termination visit [ET]) for those participants discontinuing from the study). Parental knowledge of the burden of respiratory syncytial virus (RSV) disease was assessed using a questionnaire. Parents were considered to have "good RSV awareness" if all questions were answered and at least 3 of the 4 questions regarding the burden of RSV disease were answered correctly.
One RSV season (5 months)
Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale
The therapeutic effect of palivizumab was assessed by the treating physician using a visual analog scale from 0 to 10, where 0 indicated that palivizumab did not match expectations at all and 10 indicated that palivizumab met all expectations. The physician rated palivizumab treatment for each participant at the last study visit (LSV) or, in the case of participants withdrawing from the study, at the early termination (ET) visit.
One RSV season (5 months), end of study
Amstetten
3300
Austria
Site Reference ID/Investigator# 52873
Feldkirch
6800
Austria
Site Reference ID/Investigator# 40437
Gänserndorf
2230
Austria
Site Reference ID/Investigator# 30843
Hollabrunn
2020
Austria
Site Reference ID/Investigator# 27767
Judenburg
8750
Austria
Site Reference ID/Investigator# 27770
Klagenfurt
9020
Austria
Site Reference ID/Investigator# 27777
Klosterneuburg
3400
Austria
Site Reference ID/Investigator# 30842
Krems
3500
Austria
Site Reference ID/Investigator# 27771
Leonding
4060
Austria
Site Reference ID/Investigator# 52867
Linz
4020
Austria
Site Reference ID/Investigator# 58943
Linz
4020
Austria
Site Reference ID/Investigator# 18603
Linz
4030
Austria
Site Reference ID/Investigator# 40445
Linz
4040
Austria
Site Reference ID/Investigator# 52874
Linz
4040
Austria
Site Reference ID/Investigator# 52870
Mattersburg
7210
Austria
Site Reference ID/Investigator# 48262
Neufeld
2491
Austria
Site Reference ID/Investigator# 27775
Purkersdorf
3002
Austria
Site Reference ID/Investigator# 30850
Sankt Pölten
3100
Austria
Site Reference ID/Investigator# 27765
Scheibbs
3270
Austria
Site Reference ID/Investigator# 40440
Schörfling
4861
Austria
Site Reference ID/Investigator# 27764
Telfs
6410
Austria
Site Reference ID/Investigator# 40439
Traisen
3160
Austria
Site Reference ID/Investigator# 30848
Tulln
3400
Austria
Site Reference ID/Investigator# 27776
Tulln
3430
Austria
Site Reference ID/Investigator# 30845
Vienna
1020
Austria
Site Reference ID/Investigator# 30849
Vienna
1030
Austria
Site Reference ID/Investigator# 40432
Vienna
1030
Austria
Site Reference ID/Investigator# 40447
Vienna
1030
Austria
Site Reference ID/Investigator# 27773
Vienna
1040
Austria
Site Reference ID/Investigator# 52879
Vienna
1060
Austria
Site Reference ID/Investigator# 27769
Vienna
1090
Austria
Site Reference ID/Investigator# 40446
Vienna
1100
Austria
Site Reference ID/Investigator# 52878
Vienna
1100
Austria
Site Reference ID/Investigator# 27774
Vienna
1110
Austria
Site Reference ID/Investigator# 27762
Vienna
1120
Austria
Site Reference ID/Investigator# 27763
Vienna
1150
Austria
Site Reference ID/Investigator# 40442
Vienna
1190
Austria
Site Reference ID/Investigator# 30851
Vienna
1200
Austria
Site Reference ID/Investigator# 58942
Vienna
1200
Austria
Site Reference ID/Investigator# 30846
Vienna
1210
Austria
Site Reference ID/Investigator# 30847
Vienna
1210
Austria
Site Reference ID/Investigator# 57793
Vienna
1210
Austria
Site Reference ID/Investigator# 30852
Vienna
1220
Austria
Site Reference ID/Investigator# 40425
Vienna
1220
Austria
FG000124 subjects
Participants Treated With Palivizumab
FG000120 subjects
Number of Participants Analyzed
FG000120 subjects
COMPLETED
FG000102 subjects
NOT COMPLETED
FG00022 subjects
Type
Comment
Reasons
Parental desire
FG0008 subjects
Screen failure, did not take palivizumab
FG0004 subjects
Noncompliance
FG0002 subjects
Quota used up (insurance reimb issue)
FG0002 subjects
Changed doctors
FG0002 subjects
Parents thought too many injections
FG0002 subjects
End of RSV season nearly reached
FG0001 subjects
Mother unconvinced of the necessity
FG0001 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
RSV Season 1
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
BG001
RSV Season 2
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
BG002
RSV Season 3
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
BG003
No Matching RSV Season
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00039
BG00145
BG00232
BG0034
BG004120
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
The chronological age of participants at study entry.
Number
Participants
Title
Denominators
Categories
Less than 1 month
Title
Measurements
BG0001
BG0011
BG0022
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00121
BG002
Gestational age
The gestational age of participants at birth in week of gestation.
Number
Participants
Title
Denominators
Categories
23 weeks
Title
Measurements
BG0000
BG0011
BG002
Body weight
The body weight of participants at the first study visit.
Mean
Standard Deviation
kilograms
Title
Denominators
Categories
Title
Measurements
BG0003.9± 1.4
BG0013.8± 1.5
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Injections Per Patient Per Season
The average number of injections administered per participant within a respiratory syncytial virus season.
Participants who were administered palivizumab were included in the analysis.
Posted
Mean
Standard Deviation
Injections administered
One RSV season (5 months)
ID
Title
Description
OG000
RSV Season 1
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
OG001
RSV Season 2
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
OG002
RSV Season 3
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
OG003
No Matching RSV Season
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
OG004
Total
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Units
Counts
Participants
OG00039
OG00145
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.8± 1.3
OG0013.9± 1.1
OG0024.0± 1.4
OG003
Primary
Body Site of Injections Per Administration
The body site of injection administration for participants at each study visit.
The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.
Posted
Number
participants
One RSV season (5 months)
ID
Title
Description
OG000
RSV Season 1
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
OG001
RSV Season 2
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
OG002
RSV Season 3
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
OG003
No Matching RSV Season
Primary
Interval Between Administrations
The average number of days that elapsed between palivizumab injections administered at the previous study visit.
The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.
Posted
Mean
Standard Deviation
Days
One RSV season (5 months)
ID
Title
Description
OG000
RSV Season 1 (S1)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
OG001
RSV Season 2 (S2)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
OG002
RSV Season 3 (S3)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
OG003
No Matching RSV Season (NS)
Primary
Dosage Per Administration
The median dose and range of palivizumab (milligrams) that was administered at each study visit.
The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.
Posted
Median
Full Range
milligrams
One RSV season (5 months)
ID
Title
Description
OG000
RSV Season 1 (S1)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
OG001
RSV Season 2 (S2)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
OG002
RSV Season 3 (S3)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
OG003
No Matching RSV Season (NS)
Secondary
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
The clinician who administered the palivizumab injection was asked to rate pain during injection using a visual analog scale (VAS) and the Modified Behavior Pain Scale (MBPS) as published by Carbajal et al., 2008. The VAS ranged from 0 (no pain) to 100 (maximum pain). The Modified Behavioral Pain Scale ranged from 0 (no pain) to 10 (maximum pain) through the evaluation of 3 items: Facial expressions, cry, and movements. If more than one injection was given at a visit, then the first injection was rated.
The analysis included participants who were administered palivizumab and had data available for the study visits listed.
Posted
Mean
Standard Deviation
units on a scale
One RSV season (5 months)
ID
Title
Description
OG000
RSV Season 1 (S1)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
OG001
RSV Season 2 (S2)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
OG002
RSV Season 3 (S3)
Secondary
Parents Knowledge of Burden of RSV Disease Via Interview by Physician
An informational brochure was given to parents of participants. Parents were interviewed by the treating physician at the first study visit (V1) and last study visit (LSV) (or early termination visit [ET]) for those participants discontinuing from the study). Parental knowledge of the burden of respiratory syncytial virus (RSV) disease was assessed using a questionnaire. Parents were considered to have "good RSV awareness" if all questions were answered and at least 3 of the 4 questions regarding the burden of RSV disease were answered correctly.
The analysis included parents of participants who were administered and had data available for the study visits listed.
Posted
Number
Parents of participants
One RSV season (5 months)
ID
Title
Description
OG000
RSV Season 1 (S1)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
OG001
RSV Season 2 (S2)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
OG002
RSV Season 3 (S3)
Secondary
Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale
The therapeutic effect of palivizumab was assessed by the treating physician using a visual analog scale from 0 to 10, where 0 indicated that palivizumab did not match expectations at all and 10 indicated that palivizumab met all expectations. The physician rated palivizumab treatment for each participant at the last study visit (LSV) or, in the case of participants withdrawing from the study, at the early termination (ET) visit.
The analysis included participants who were administered palivizumab and had data available for the study visits listed. A total of 100 participants were rated at the last study visit; 2 did not have ratings. A total of 18 participants who discontinued from the study were rated at the early termination visit.
Posted
Mean
Standard Deviation
units on a scale
One RSV season (5 months), end of study
ID
Title
Description
OG000
RSV Season 1 (S1)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
OG001
RSV Season 2 (S2)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
Time Frame
Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab
Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
5
120
22
120
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0002 affected120 at risk
Bronchitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 affected120 at risk
Inguinal hernia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected120 at risk
Hospitalisation
Surgical and medical procedures
MedDRA 12.0
Systematic Assessment
EG0001 affected120 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bronchitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0004 affected120 at risk
Rhinitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0003 affected120 at risk
Varicella
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0003 affected120 at risk
Bronchitis viral
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0002 affected120 at risk
Nasopharyngitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0002 affected120 at risk
Respiratory tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0002 affected120 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0002 affected120 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0002 affected120 at risk
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0002 affected120 at risk
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Point of Contact
Title
Organization
Phone
Extension
Email
Global Medical Services
Abbott
1-800-633-9110
ID
Term
D047928
Premature Birth
D010349
Patient Compliance
Ancestor Terms
ID
Term
D007752
Obstetric Labor, Premature
D007744
Obstetric Labor Complications
D011248
Pregnancy Complications
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D010342
Patient Acceptance of Health Care
D000074822
Treatment Adherence and Compliance
D015438
Health Behavior
D001519
Behavior
Browse Leaves
Not provided
Browse Branches
Not provided
1
BG0045
1 month
Title
Measurements
BG00010
BG00115
BG0027
BG0030
BG00432
Greater than 1 and less than or equal to 2 months
Title
Measurements
BG00019
BG00112
BG00214
BG0033
BG00448
3 months
Title
Measurements
BG0004
BG0016
BG0024
BG0030
BG00414
4 to 4.5 months
Title
Measurements
BG0001
BG0011
BG0022
BG0030
BG0044
5 months
Title
Measurements
BG0000
BG0014
BG0021
BG0030
BG0045
6 months
Title
Measurements
BG0001
BG0014
BG0020
BG0030
BG0045
7 months
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
8 months
Title
Measurements
BG0000
BG0012
BG0020
BG0030
BG0042
9 months
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
10 months
Title
Measurements
BG0002
BG0010
BG0020
BG0030
BG0042
Age not reported
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0041
13
BG0033
BG00450
Male
BG00026
BG00124
BG00219
BG0031
BG00470
0
BG0030
BG0041
28 weeks
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
31 weeks
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
33 weeks
Title
Measurements
BG00024
BG00118
BG00214
BG0031
BG00457
34 weeks
Title
Measurements
BG0009
BG00118
BG00212
BG0033
BG00442
35 weeks
Title
Measurements
BG0006
BG0018
BG0024
BG0030
BG00418
4.1
± 1.6
BG0033.5± 1.1
BG0043.9± 1.5
4
OG004120
1.0
± 0.0
OG0043.8± 1.3
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
OG004
Total
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Units
Counts
Participants
OG00039
OG00145
OG00232
OG0034
OG004120
Title
Denominators
Categories
Visit 1: Thigh
Title
Measurements
OG00038
OG00144
OG00229
OG0034
OG004115
Visit 2: Thigh
Title
Measurements
OG00034
OG00143
OG00232
OG003
Visit 3: Thigh
Title
Measurements
OG00031
OG00142
OG00223
OG003
Visit 3: Other location
Title
Measurements
OG0000
OG0010
OG0021
OG003
Visit 4: Thigh
Title
Measurements
OG00020
OG00128
OG00222
OG003
Visit 4: Other location
Title
Measurements
OG0000
OG0010
OG0021
OG003
Visit 5: Thigh
Title
Measurements
OG00015
OG00113
OG00215
OG003
Visit 5: Other location
Title
Measurements
OG0000
OG0010
OG0021
OG003
Visit 6: Thigh
Title
Measurements
OG0005
OG0013
OG0023
OG003
Visit 6: Other location
Title
Measurements
OG0000
OG0010
OG0021
OG003
Visit 7: Thigh
Title
Measurements
OG0002
OG0013
OG0020
OG003
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
OG004
Total
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Units
Counts
Participants
OG00039
OG00145
OG00232
OG0034
OG004120
Title
Denominators
Categories
V2 (S1 n=33; S2 n=42; S3 n=29; NS n=0)
Title
Measurements
OG00028.5± 9.1
OG00130.6± 9.2
OG00228.6± 9.2
OG003NA± NANo data reported for this subgroup at this time point.
OG00429.4± 9.1
V3 (S1 n=32; S2 n=42; S3 n=24; NS n=0)
Title
Measurements
OG00033.2± 12.4
OG00134.7± 12.1
OG00230.3± 4.8
OG003
V4 (S1 n=20; S2 n=28; S3 n=23; NS n=0)
Title
Measurements
OG00034.5± 9.4
OG00141.8± 48.2
OG00232.0± 5.5
OG003
V5 (S1 n=15; S2 n=13; S3 n=16; NS n=0)
Title
Measurements
OG00033.4± 13.9
OG00132.5± 12.9
OG00228.4± 5.5
OG003
V6 (S1 n=6; S2 n=3; S3 n=4; NS n=0)
Title
Measurements
OG00024.8± 10.3
OG00130.0± 1.7
OG00229.5± 1.7
OG003
V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0)
Title
Measurements
OG00034.0± 0.0
OG00130.0± 1.7
OG002NA± NANo data reported for this subgroup at this time point.
OG003
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
OG004
Total
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Units
Counts
Participants
OG00039
OG00145
OG00232
OG0034
OG004120
Title
Denominators
Categories
V1 (S1 n=36; S2 n=44; S3 n=26; NS n=4)
Title
Measurements
OG00060.0± 1925.2(40.0 to 7500.0)
OG00150.0± 25.8(24.0 to 150.0)
OG00273.5± 26.2(30.0 to 125.0)
OG00352.5± 24.2(50.0 to 100.0)
OG00460.0± 1134.4(24.0 to 7500.0)
V2 (S1 n=32; S2 n=43; S3 n=27; NS n=0)
Title
Measurements
OG00077.5± 1210.7(50.0 to 5000.0)
OG00170.0± 23.2(50.0 to 150.0)
OG00284.0± 22.0(43.0 to 130.0)
OG003
V3 (S1 n=29; S2 n=42; S3 n=21; NS n=0)
Title
Measurements
OG00085.0± 3077.5(60.0 to 10000.0)
OG00180.0± 22.7(45.0 to 150.0)
OG00296.0± 21.1(58.0 to 140.0)
OG003
V4 (S1 n=20; S2 n=28; S3 n=20; NS n=0)
Title
Measurements
OG00099.0± 1767.4(73.0 to 8000.0)
OG00197.5± 285.3(54.0 to 1600.0)
OG002100.0± 24.1(65.0 to 150.0)
OG003
V5 (S1 n=15; S2 n=13; S3 n=13; NS n=0)
Title
Measurements
OG000100.0± 7.8(80.0 to 111.0)
OG001100.0± 18.2(80.0 to 150.0)
OG002100.0± 20.1(78.0 to 150.0)
OG003
V6 (S1 n=5; S2 n=3; S3 n=2; NS n=0)
Title
Measurements
OG000100.0± 122(90.0 to 123.0)
OG001100.0± 17.3(100.0 to 130.0)
OG002101.0± 8.5(95.0 to 107.0)
OG003
V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0)
Title
Measurements
OG000100.0± 0(100.0 to 100.0)
OG001100.0± 0(100.0 to 100.0)
OG002NA± 0(NA to NA)No data reported for this subgroup at this time point.
OG003
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
OG003
No Matching RSV Season (NS)
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
OG004
Total
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Units
Counts
Participants
OG00039
OG00145
OG00232
OG0034
OG004120
Title
Denominators
Categories
V1 VAS (S1 n=37; S2 n=43; S3 n=22; NS n=4)
Title
Measurements
OG00050.2± 22.3
OG00164.1± 19.5
OG00253.5± 25.7
OG00362.5± 9.6
OG00457.0± 22.3
V1 MBPS (S1 n=37; S2 n=43; S3 n=29; NS n=4)
Title
Measurements
OG0007.2± 1.7
OG0017.5± 1.5
OG0026.9± 1.8
OG003
V2 VAS (S1 n=33; S2 n=42; S3 n=25; NS n=0)
Title
Measurements
OG00055.3± 23.4
OG00165.6± 18.2
OG00257.2± 27.3
OG003
V2 MBPS (S1 n=34; S2 n=42; S3 n=31; NS n=0)
Title
Measurements
OG0007.2± 1.6
OG0017.9± 1.5
OG0027.3± 1.9
OG003
V3 VAS (S1 n=31; S2 n=41; S3 n=20; NS n=0)
Title
Measurements
OG00055.9± 23.6
OG00167.8± 16.4
OG00260.0± 26.6
OG003
V3 MBPS (S1 n=31; S2 n=41; S3 n=24; NS n=0)
Title
Measurements
OG0007.3± 1.5
OG0017.9± 1.3
OG0027.6± 1.8
OG003
V4 VAS (S1 n=20; S2 n=28; S3 n=19; NS n=0)
Title
Measurements
OG00060.3± 24.5
OG00166.3± 17.1
OG00262.7± 23.5
OG003
V4 MBPS (S1 n=20; S2 n=28; S3 n=22; NS n=0)
Title
Measurements
OG0008.2± 1.2
OG0017.7± 1.4
OG0027.4± 1.3
OG003
V5 VAS (S1 n=15; S2 n=13; S3 n=14; NS n=0)
Title
Measurements
OG00055.1± 28.1
OG00165.8± 13.2
OG00264.4± 27.4
OG003
V5 MBPS (S1 n=15; S2 n=13; S3 n=16; NS n=0)
Title
Measurements
OG0006.9± 2.1
OG0017.2± 1.4
OG0028.2± 1.5
OG003
V6 VAS (S1 n=5; S2 n=3; S3 n=4; NS n=0)
Title
Measurements
OG00051.2± 31.2
OG00178.3± 2.9
OG00272.0± 34.3
OG003
V6 MBPS (S1 n=5; S2 n=3; S3 n=4; NS n=0)
Title
Measurements
OG0007.4± 2.2
OG0017.3± 0.6
OG0028.8± 1.9
OG003
V7 VAS (S1 n=2; S2 n=3; S3 n=0; NS n=0)
Title
Measurements
OG00030.0± 0.0
OG00173.3± 11.5
OG002NA± NANo data reported for this subgroup at this time point.
OG003
V7 MBPS (S1 n=2; S2 n=3; S3 n=0; NS n=0)
Title
Measurements
OG0004.0± 1.4
OG0016.7± 1.2
OG002NA± NANo data reported for this subgroup at this time point.
OG003
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
OG003
No Matching RSV Season (NS)
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
OG004
Total
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Units
Counts
Participants
OG00039
OG00145
OG00232
OG0034
OG004120
Title
Denominators
Categories
Good RSV Awareness V1 (S1=39;S2=42;S3=32;NS=4)
Title
Measurements
OG00039
OG00136
OG00231
OG0034
OG004110
Good RSV Awareness LSV (S1=28;S2=32;S3=29;NS=4)
Title
Measurements
OG00028
OG00132
OG00229
OG003
Good RSV Awareness ET (S1=7;S2=8;S3=3;NS=0)
Title
Measurements
OG0007
OG0017
OG0023
OG003
OG002
RSV Season 3 (S3)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
OG003
No Matching RSV Season (NS)
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
OG004
Total
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Units
Counts
Participants
OG00039
OG00145
OG00232
OG0034
OG004120
Title
Denominators
Categories
Rating at LSV (S1 n=30;S2 n=36;S3 n=27;NS n=4)
Title
Measurements
OG0009.9± 0.4
OG0019.8± 0.6
OG0029.9± 0.5
OG00310.0± 0.0
OG0049.9± 0.5
Rating at ET visit (S1 n=7;S2 n=8;S3 n=3;NS n=0)
Title
Measurements
OG00010.0± 0.0
OG0019.5± 0.9
OG00210.0± 0.0
OG003
0
OG004109
0
OG00496
0
OG0041
0
OG00470
0
OG0041
0
OG00443
0
OG0041
0
OG00411
0
OG0041
0
OG0045
NA
± NA
No data reported for this subgroup at this time point.
OG00433.1± 10.9
NA
± NA
No data reported for this subgroup at this time point.
OG00436.6± 30.8
NA
± NA
No data reported for this subgroup at this time point.
OG00431.3± 11.2
NA
± NA
No data reported for this subgroup at this time point.
OG00427.5± 7.2
NA
± NA
No data reported for this subgroup at this time point.
OG00431.6± 2.5
NA
± 0
(NA to NA)
No data reported for this subgroup at this time point.
OG00479.5± 686.0(43.0 to 5000.0)
NA
± 0
(NA to NA)
No data reported for this subgroup at this time point.
OG00485.5± 1795.8(45.0 to 10000.0)
NA
± 0
(NA to NA)
No data reported for this subgroup at this time point.
OG004100.0± 973.1(54.0 to 8000.0)
NA
± 0
(NA to NA)
No data reported for this subgroup at this time point.
OG004100.0(78.0 to 150.0)
NA
± 0
(NA to NA)
No data reported for this subgroup at this time point.
OG004100.0± 12.5(90.0 to 130.0)
NA
± 0
(NA to NA)
No data reported for this subgroup at this time point.
OG004100.0± 0(100.0 to 100.0)
7.8
± 1.5
OG0047.2± 1.7
NA
± NA
No data reported for this subgroup at this time point.
OG00460.1± 22.7
NA
± NA
No data reported for this subgroup at this time point.
OG0047.5± 1.6
NA
± NA
No data reported for this subgroup at this time point.
OG00462.1± 21.9
NA
± NA
No data reported for this subgroup at this time point.
OG0047.7± 1.5
NA
± NA
No data reported for this subgroup at this time point.
OG00463.5± 21.2
NA
± NA
No data reported for this subgroup at this time point.
OG0047.7± 1.3
NA
± NA
No data reported for this subgroup at this time point.
OG00461.5± 24.1
NA
± NA
No data reported for this subgroup at this time point.
OG0047.5± 1.8
NA
± NA
No data reported for this subgroup at this time point.
OG00464.9± 28.8
NA
± NA
No data reported for this subgroup at this time point.
OG0047.8± 1.8
NA
± NA
No data reported for this subgroup at this time point.
OG00456.0± 25.1
NA
± NA
No data reported for this subgroup at this time point.
OG0045.6± 1.8
4
OG00493
0
OG00417
NA
± NA
No participants in this subgroup were rated at an early termination visit.