Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA

This study has been completed.
Sponsor:
Collaborator:
Assign Group Data Management Biostatistics
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01077271
First received: February 25, 2010
Last updated: August 20, 2012
Last verified: August 2012
Results First Received: May 17, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Premature Infants

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab

Participant Flow:   Overall Study
    Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab  
STARTED     124  
Participants Treated With Palivizumab     120  
Number of Participants Analyzed     120  
COMPLETED     102  
NOT COMPLETED     22  
Parental desire                 8  
Screen failure, did not take palivizumab                 4  
Noncompliance                 2  
Quota used up (insurance reimb issue)                 2  
Changed doctors                 2  
Parents thought too many injections                 2  
End of RSV season nearly reached                 1  
Mother unconvinced of the necessity                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)
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)
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)
No Matching RSV Season Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
Total Total of all reporting groups

Baseline Measures
    RSV Season 1     RSV Season 2     RSV Season 3     No Matching RSV Season     Total  
Number of Participants  
[units: participants]
  39     45     32     4     120  
Age, Customized [1]
[units: Participants]
         
Less than 1 month     1     1     2     1     5  
1 month     10     15     7     0     32  
Greater than 1 and less than or equal to 2 months     19     12     14     3     48  
3 months     4     6     4     0     14  
4 to 4.5 months     1     1     2     0     4  
5 months     0     4     1     0     5  
6 months     1     4     0     0     5  
7 months     0     0     1     0     1  
8 months     0     2     0     0     2  
9 months     0     0     1     0     1  
10 months     2     0     0     0     2  
Age not reported     1     0     0     0     1  
Gender  
[units: participants]
         
Female     13     21     13     3     50  
Male     26     24     19     1     70  
Gestational age [2]
[units: Participants]
         
23 weeks     0     1     0     0     1  
28 weeks     0     0     1     0     1  
31 weeks     0     0     1     0     1  
33 weeks     24     18     14     1     57  
34 weeks     9     18     12     3     42  
35 weeks     6     8     4     0     18  
Body weight [3]
[units: kilograms]
Mean ± Standard Deviation
  3.9  ± 1.4     3.8  ± 1.5     4.1  ± 1.6     3.5  ± 1.1     3.9  ± 1.5  
[1] The chronological age of participants at study entry.
[2] The gestational age of participants at birth in week of gestation.
[3] The body weight of participants at the first study visit.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Injections Per Patient Per Season   [ Time Frame: One RSV season (5 months) ]

2.  Primary:   Body Site of Injections Per Administration   [ Time Frame: One RSV season (5 months) ]

3.  Primary:   Interval Between Administrations   [ Time Frame: One RSV season (5 months) ]

4.  Primary:   Dosage Per Administration   [ Time Frame: One RSV season (5 months) ]

5.  Secondary:   Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)   [ Time Frame: One RSV season (5 months) ]

6.  Secondary:   Parents Knowledge of Burden of RSV Disease Via Interview by Physician   [ Time Frame: One RSV season (5 months) ]

7.  Secondary:   Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale   [ Time Frame: One RSV season (5 months), end of study ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110


No publications provided


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01077271     History of Changes
Other Study ID Numbers: P11-040
Study First Received: February 25, 2010
Results First Received: May 17, 2012
Last Updated: August 20, 2012
Health Authority: Austria: Federal Office for Safety in Health Care