Randomized trial on the use of rhEPO in neonates with Rhesus alloimmunization.
- Conditions
- Recombinant Human Erythropoietin (rhEPO)Hemolytic Disease of the Newborn Red blood cell alloimmunization Intrauterine red cell transfusion
- Registration Number
- NL-OMON26568
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
1. Smits-Wintjens VE, Walther FJ, Lopriore E. Rhesus haemolytic disease of the newborn: Postnatal management, associated morbidity and long-term outcome. Semin Fetal Neonatal Med. 2008;13:265-271.<br> 2. De Boer IP, Zeestraten EC, Lopriore E, van Kamp IL, Kanhai HH, Walther FJ. Pediatric outcome in Rhesus hemolytic disease treated with and without intrauterine transfusion. Am J Obstet Gynecol. 2008;198:54.<br> 3. Rath ME, Smits-Wintjens VE, Lindenburg I, Brand A, Oepkes D, Walther FJ, et al. Top-up transfusions in neonates with Rh hemolytic disease in relation to exchange transfusions. Vox Sang. 2010;99:65-70.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 132
All (near)-term neonates (gestational age ≥ 35 weeks) with HDN (due to Rhesus-D, -C, -c, -E, Kell or other red blood cell alloimmunization) treated with or without IUT and admitted to the Leiden University Medical Center (LUMC) are eligible for the study. The LUMC is the single national referral center in the Netherlands for pregnancies complicated by maternal red blood cell alloimmunization.
Preterm neonates (gestational age < 35 weeks).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Number of top-up transfusions required per infant;<br /><br>2. The percentage of infants requiring a top-up transfusion up to 3 months of life.
- Secondary Outcome Measures
Name Time Method 1. Number of days of admission for top-up transfusions;<br /><br>2. Reduction in ferritin levels;<br /><br>3. Long term neurodevelopmental outcome at 2 years of age using the BSID-III test.<br>