About divi study

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Does treating preterm babies with darbepoetin (Darbe) and a type of  slow-release intravenous (IV) iron supplement lead to fewer blood  transfusions and allow your baby to maintain healthy nutritional iron  levels? How does this compare to the current standard care? This is the  purpose of this study.  We will compare the number of transfusions and  iron levels from babies who receive Darbe + IV iron with those who  follow current care guidelines.   

Both transfusions and low iron can  negatively affect brain development. To see if having fewer transfusions  and better iron levels can improve developmental outcomes, we will  follow your child’s development up to 2 years of age.  

Darbe is a medicine that is helps our bodies naturally make red blood  cells (cells that carry oxygen in the blood). This medication is very  common and has been safely used for decades to help premature babies.  Using Darbe increases the need for iron since iron is needed to make red  blood cells.  

Slow-release IV iron is a type of iron supplement that stays in the  body for longer than oral supplements, so fewer doses are needed.  

 Babies who are enrolled in the study will be randomly selected to receive either: 

1) Standard care in the NICU, with nutritional iron given as oral supplements. 

2)  Darbe + IV iron 

• Our NICU checks iron labs every 2 weeks. We will continue to do this  for all enrolled babies and treat with iron when needed. We will also  check your baby’s urine and stool for differences in how your baby  responds to oral iron compared to IV iron. 
• We will look at  medical records of the mom and baby about the pregnancy, gestational  age, growth, lab tests, and medical problems that may occur.  
• We will track how many blood transfusions your child is given, and how many doses of oral or IV iron they need.  
• 1)  Standard care in the NICU, with nutritional iron given as oral supplements. inic (IDFC) at 3 to 6 month intervals until they are 2 years  old to see if the new treatments improve outcomes.   

Your baby will be  closely monitored by multiple teams while in the hospital. Participation  in the DIVI Study will not prevent your baby from receiving any of the  routine care that other babies get while in the NICU. 

 Babies who receive Darbe + IV iron may need fewer blood transfusions  and have better iron levels. This may result in better long-term  outcomes.  

All participants will have the research team help them  through the NICU stay and follow-up to 2 years. 

The information learned  from this study will benefit other premature babies in the future.  

Darbe increases red blood cell production, which increases the need  for iron.  

Side effects in adults may include increased blood pressure,  abnormal clotting (thrombosis), stroke and death very rarely. None of  these adverse effects have been reported in infants, but we will  carefully monitor for them.  

Slow-release IV iron preparations are safe  in children and adults (including pregnant women) but have not been  tested in preterm infants. Side effects in adults are uncommon, but  include rash, flushing, low blood pressure, low heart rate and seizures.

Participating in any study is voluntary. If you may be interested  in participating in this study, please speak to one of the researchers. 

Sandra Juul, MD, PhD, Professor

Kendell German, MD,  Assistant  Professor

Mihai Puia-Dumitrescu, MD,  Assistant Professor

Dennis  Mayock, MD, Professor

Sarah Kolnik, MD,  Assistant Professor

Sara  Neches, MD, Neonatology Fellow 

John Feltner, MS

Devinae McNeil, MS