Trial Outcomes & Findings for Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease (NCT NCT00288600)
NCT ID: NCT00288600
Last Updated: 2016-01-08
Results Overview
NEED OF EXCHANGE TRANSFUSION FOLLOWING GUIDELINES
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
92 participants
Primary outcome timeframe
10 DAYS OF LIFE
Results posted on
2016-01-08
Participant Flow
Assessed for eligibility 125 Excluded (n= 33) Not meeting inclusion criteria (n= 26) Declined to participate (n= 4) Other reasons (n= 3)
Participant milestones
| Measure |
Experimental Group
Intravenous Immunoglobulin
Intravenous Immunoglobulin: Intravenous Immunoglobulin
|
Control Group
Normal Saline solution
Normal saline solution: Normal saline solution 10 ml/Kg
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
|
Overall Study
COMPLETED
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease
Baseline characteristics by cohort
| Measure |
Experimental Group - Immunoglobulin
n=46 Participants
Intravenous Immunoglobulin and Phototherapy
Intravenous Immunoglobulin: Intravenous Immunoglobulin
|
Control Group- Normal Saline
n=46 Participants
Normal Saline solution and Phototherapy
Normal saline solution: Normal saline solution 10 ml/Kg
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3 hours of life
n=5 Participants
|
3 hours of life
n=7 Participants
|
3 hours of life
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
46 participants
n=5 Participants
|
46 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
maternal age
|
30.6 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
30.0 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
TSB at birth
|
2.42 mg/dl
STANDARD_DEVIATION 1.29 • n=5 Participants
|
2.87 mg/dl
STANDARD_DEVIATION 1.49 • n=7 Participants
|
2.64 mg/dl
STANDARD_DEVIATION 1.36 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 DAYS OF LIFEPopulation: NUMBER
NEED OF EXCHANGE TRANSFUSION FOLLOWING GUIDELINES
Outcome measures
| Measure |
Experimental Group
n=46 Participants
Intravenous Immunoglobulin
Intravenous Immunoglobulin: Intravenous Immunoglobulin
|
Control Group
n=46 Participants
Normal Saline solution
Normal saline solution: Normal saline solution 10 ml/Kg
|
|---|---|---|
|
Need of Exchange Transfusion
|
6 participants
|
7 participants
|
Adverse Events
Experimental Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place