Premature InfantsNCT01077271

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

An observational study of Premature Infants, run by Abbott at 45 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 1 year
Conditions the study is for: Premature Infants
How many people: 124 participants
Where: 45 sitesAustria
Study dates: Oct 2008to May 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 1 year
All sexes
No healthy volunteers
Child

Study population: Medical practices specialized in pediatrics.

Who may be able to join

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)

Who cannot join

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
Patients with chronic lung disease
Patients with congenital heart disease
Greater than 36 weeks gestational age

Trial locations and contacts

45 sites in 1 country.

City, postcode or hospital

45 sites in 1 country

Austria45 sites

Site Reference ID/Investigator# 27772
Amstetten, 3300
Site Reference ID/Investigator# 52871
Amstetten, 3300
Site Reference ID/Investigator# 52873
Feldkirch, 6800
Site Reference ID/Investigator# 40437
Gänserndorf, 2230
Site Reference ID/Investigator# 30843
Hollabrunn, 2020
Site Reference ID/Investigator# 27767
Judenburg, 8750
Site Reference ID/Investigator# 27770
Klagenfurt, 9020
Site Reference ID/Investigator# 27777
Klosterneuburg, 3400
Site Reference ID/Investigator# 30842
Krems, 3500
Site Reference ID/Investigator# 27771
Leonding, 4060
Site Reference ID/Investigator# 52867
Linz, 4020
Site Reference ID/Investigator# 58943
Linz, 4020
Site Reference ID/Investigator# 18603
Linz, 4030
Site Reference ID/Investigator# 40445
Linz, 4040
Site Reference ID/Investigator# 52874
Linz, 4040
Site Reference ID/Investigator# 52870
Mattersburg, 7210
Site Reference ID/Investigator# 48262
Neufeld, 2491
Site Reference ID/Investigator# 27775
Purkersdorf, 3002
Site Reference ID/Investigator# 30850
Sankt Pölten, 3100
Site Reference ID/Investigator# 27765
Scheibbs, 3270
Site Reference ID/Investigator# 40440
Schörfling, 4861
Site Reference ID/Investigator# 27764
Telfs, 6410
Site Reference ID/Investigator# 40439
Traisen, 3160
Site Reference ID/Investigator# 30848
Tulln, 3400
Site Reference ID/Investigator# 27776
Tulln, 3430
Site Reference ID/Investigator# 30845
Vienna, 1020
Site Reference ID/Investigator# 30849
Vienna, 1030
Site Reference ID/Investigator# 40432
Vienna, 1030
Site Reference ID/Investigator# 40447
Vienna, 1030
Site Reference ID/Investigator# 27773
Vienna, 1040
Site Reference ID/Investigator# 52879
Vienna, 1060
Site Reference ID/Investigator# 27769
Vienna, 1090
Site Reference ID/Investigator# 40446
Vienna, 1100
Site Reference ID/Investigator# 52878
Vienna, 1100
Site Reference ID/Investigator# 27774
Vienna, 1110
Site Reference ID/Investigator# 27762
Vienna, 1120
Site Reference ID/Investigator# 27763
Vienna, 1150
Site Reference ID/Investigator# 40442
Vienna, 1190
Site Reference ID/Investigator# 30851
Vienna, 1200
Site Reference ID/Investigator# 58942
Vienna, 1200
Site Reference ID/Investigator# 30846
Vienna, 1210
Site Reference ID/Investigator# 30847
Vienna, 1210
Site Reference ID/Investigator# 57793
Vienna, 1210
Site Reference ID/Investigator# 30852
Vienna, 1220
Site Reference ID/Investigator# 40425
Vienna, 1220

Other trials in Austria

About this study

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

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.

Conditions: Premature Infants
Keywords: Premature infants, Respiratory Syncytial Virus (RSV), Compliance, Palivizumab
Medical subject headings: Premature Birth, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01077271
Study group	Role	What they receive
Premature infants 33 - 35 wGA prophylaxed with palivizumab		Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with Synagis (palivizumab)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Injections Per Patient Per Season
The average number of injections administered per participant within a respiratory syncytial virus season.
Measured: One RSV season (5 months)
Body Site of Injections Per Administration
The body site of injection administration for participants at each study visit.
Measured: One RSV season (5 months)
Interval Between Administrations
The average number of days that elapsed between palivizumab injections administered at the previous study visit.
Measured: One RSV season (5 months)
Dosage Per Administration
The median dose and range of palivizumab (milligrams) that was administered at each study visit.
Measured: One RSV season (5 months)

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: One RSV season (5 months), end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008May 2011

First posted1 Mar 2010 (estimated)
Study startOct 2008
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Premature InfantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01077271
Sponsor's protocol ID: P11-040
Status last verified: Aug 2012
First submitted: 25 Feb 2010
Last updated: 21 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant

All Premature Infants trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01077271
Acronym / sponsor ID: P11-040
Conditions: Premature Infants
Keywords: Premature infants, Respiratory Syncytial Virus (RSV), Compliance, Palivizumab
Study type: Observational
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Assign Data Management and Biostatistics GmbH
Study start: Oct 2008
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 1 Mar 2010 (estimated)
Results: Posted 21 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Premature infants 33 - 35 wGA prophylaxed with palivizumab	–	–Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with Synagis (palivizumab)

Who may qualify

Ages: Up to 1 year
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Medical practices specialized in pediatrics.

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (6 listed)

Patients without Synagis prescription
Patients who meet contraindications as outlined in the latest version of Synagis summary of product characteristics (SmPC):
Patients with chronic lung disease
Patients with congenital heart disease
Greater than 36 weeks gestational age

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Injections Per Patient Per Season
Time frame: One RSV season (5 months)
The average number of injections administered per participant within a respiratory syncytial virus season.
Body Site of Injections Per Administration
Time frame: One RSV season (5 months)
The body site of injection administration for participants at each study visit.
Interval Between Administrations
Time frame: One RSV season (5 months)
The average number of days that elapsed between palivizumab injections administered at the previous study visit.
Dosage Per Administration
Time frame: One RSV season (5 months)
The median dose and range of palivizumab (milligrams) that was administered at each study visit.

3 secondary outcomes

Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
Time frame: One RSV season (5 months)
Parents Knowledge of Burden of RSV Disease Via Interview by Physician
Time frame: 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
Time frame: One RSV season (5 months), end of study

Results and safety

Results posted to the registry on 21 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab	124	102

Primary outcome: Number of Injections Per Patient Per Season

Time frame: One RSV season (5 months). Mean (Standard Deviation). Unit: Injections administered

Measure	RSV Season 1 n = 39	RSV Season 2 n = 45	RSV Season 3 n = 32	No Matching RSV Season n = 4	Total n = 120
Value	3.8 (1.3)	3.9 (1.1)	4.0 (1.4)	1.0 (0.0)	3.8 (1.3)

Population analysed: Participants who were administered palivizumab were included in the analysis.

Primary outcome: Body Site of Injections Per Administration

Time frame: One RSV season (5 months). Number. Unit: participants

Measure	RSV Season 1 n = 39	RSV Season 2 n = 45	RSV Season 3 n = 32	No Matching RSV Season n = 4	Total n = 120
Visit 1: Thigh	38	44	29	4	115
Visit 2: Thigh	34	43	32	0	109
Visit 3: Thigh	31	42	23	0	96
Visit 3: Other location	0	0	1	0	1
Visit 4: Thigh	20	28	22	0	70
Visit 4: Other location	0	0	1	0	1
Visit 5: Thigh	15	13	15	0	43
Visit 5: Other location	0	0	1	0	1

Population analysed: The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.

Primary outcome: Interval Between Administrations

Time frame: One RSV season (5 months). Mean (Standard Deviation). Unit: Days

Measure	RSV Season 1 (S1) n = 39	RSV Season 2 (S2) n = 45	RSV Season 3 (S3) n = 32	No Matching RSV Season (NS) n = 4	Total n = 120
V2 (S1 n=33; S2 n=42; S3 n=29; NS n=0)	28.5 (9.1)	30.6 (9.2)	28.6 (9.2)	NA (NA)	29.4 (9.1)
V3 (S1 n=32; S2 n=42; S3 n=24; NS n=0)	33.2 (12.4)	34.7 (12.1)	30.3 (4.8)	NA (NA)	33.1 (10.9)
V4 (S1 n=20; S2 n=28; S3 n=23; NS n=0)	34.5 (9.4)	41.8 (48.2)	32.0 (5.5)	NA (NA)	36.6 (30.8)
V5 (S1 n=15; S2 n=13; S3 n=16; NS n=0)	33.4 (13.9)	32.5 (12.9)	28.4 (5.5)	NA (NA)	31.3 (11.2)
V6 (S1 n=6; S2 n=3; S3 n=4; NS n=0)	24.8 (10.3)	30.0 (1.7)	29.5 (1.7)	NA (NA)	27.5 (7.2)
V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0)	34.0 (0.0)	30.0 (1.7)	NA (NA)	NA (NA)	31.6 (2.5)

Population analysed: The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.

Primary outcome: Dosage Per Administration

Time frame: One RSV season (5 months). Median (Full Range). Unit: milligrams

Measure	RSV Season 1 (S1) n = 39	RSV Season 2 (S2) n = 45	RSV Season 3 (S3) n = 32	No Matching RSV Season (NS) n = 4	Total n = 120
V1 (S1 n=36; S2 n=44; S3 n=26; NS n=4)	60.0 (1925.2)	50.0 (25.8)	73.5 (26.2)	52.5 (24.2)	60.0 (1134.4)
V2 (S1 n=32; S2 n=43; S3 n=27; NS n=0)	77.5 (1210.7)	70.0 (23.2)	84.0 (22.0)	NA (0)	79.5 (686.0)
V3 (S1 n=29; S2 n=42; S3 n=21; NS n=0)	85.0 (3077.5)	80.0 (22.7)	96.0 (21.1)	NA (0)	85.5 (1795.8)
V4 (S1 n=20; S2 n=28; S3 n=20; NS n=0)	99.0 (1767.4)	97.5 (285.3)	100.0 (24.1)	NA (0)	100.0 (973.1)
V5 (S1 n=15; S2 n=13; S3 n=13; NS n=0)	100.0 (7.8)	100.0 (18.2)	100.0 (20.1)	NA (0)	100.0 (78.0 to 150.0)
V6 (S1 n=5; S2 n=3; S3 n=2; NS n=0)	100.0 (122)	100.0 (17.3)	101.0 (8.5)	NA (0)	100.0 (12.5)
V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0)	100.0 (0)	100.0 (0)	NA (0)	NA (0)	100.0 (0)

Population analysed: The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.

3 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab	5 of 120 (4.2%)	22 of 120 (18.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Premature Infants

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
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Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Growing Little PEAPODS Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Astrid Dworan-Timler, MD study director

Abbott Austria

45 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Premature Infants, run by Abbott at 45 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Injections Per Patient Per Season (time frame: One RSV season (5 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01077271.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012.