Table 1.

Ongoing Registered Neonatal RBC Transfusion Studies.

Study Title	Target Sample size	Study Goal	Registry identifier (status)*
Combining Restrictive Guidelines and a NIRS Score to Decrease RBC Transfusions	82	To determine the number of RBC transfusions received by preterm infants cared for using restrictive Hb transfusion guidelines in combination with splanchnic to cerebral oxygenation ratio assessment compared to liberal guidelines alone based on Hb level below defined values.	clinicaltrials.gov NCT02535208 (recruiting)
Withholding Feeds During Red Blood Cell Transfusion and TRAGI	154 (actual)	To investigate the effect of withholding feeds during transfusion, on the development of TRAGI	clinicaltrials.gov NCT02132819 (active, not recruiting)
Transfusion of Prematures (TOP) Trial	1824	To determine whether higher Hb thresholds for transfusing ELBW infants resulting in higher Hb levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment at 22–26 months of age.	clinicaltrials.gov NCT01702805 (recruiting)
Timing of Umbilical Cord Occlusion in Premature Babies: Delayed vs Early	150	To test the hypothesis that delayed cord clamping in the premature newborn <33 week gestation significantly decreases the need for RBC transfusions and intraventricular hemorrhage compared with early cord clamping.	clinicaltrials.gov NCT02187874 (not yet recruiting)
Umbilical Cord Blood Use For Admission Blood Tests of VLBW Preterm Neonates	225	To compare the use of cord blood vs. infant blood with the primary outcome of comparing both the absolute Hb concentration and the percent change in Hb concentration from baseline around 24 hours of life.	clinicaltrials.gov NCT02103296 (recruiting)
Effects of Placental Transfusion on Early Brain Development in Infants Born at Term	100	To measure the effects of cord clamping time on the structure and function of the developing brain at three and four years of age in healthy term infants.	clinicaltrials.gov NCT02619006 (recruiting)
Effects of Transfusion Thresholds on Neurocognitive Outcome of ELBW Infants (ETTNO) Trial	920	To compare restrictive vs. liberal RBC transfusion guidelines on long-term neuro-developmental outcome in ELBW infants.	clinicaltrials.gov NCT01393496 (active, not recruiting)
Preterm Erythropoietin Neuroprotection (PENUT) Trial	940	To determine whether EPO treatment of extremely low gestational age newborns decreases the combined outcome of death or NDI at 24–26 months corrected age.	clinicaltrials.gov NCT01378273 (recruiting)
Use of EPO to reduce top-up transfusions in neonates with RBC alloimmunization	64	To determine if treatment with EPO reduces the need for top-up transfusions in neonates with hemolytic disease of the newborn due to RBC alloimmunization treated with intrauterine transfusion	EU Clinical Trials Register 2010- 023955-27 (ongoing)

Abbreviations: NIRS, near infrared spectroscopy; RBC, red blood cell; Hb, hemoglobin; TRAGI, transfusion related acute gut injury; ELBW, extremely low birth weight; VLBW, very low birth weight; EPO, recombinant human erythropoietin; EU, European Union.

^*Status as of 02/28/2016 from a search of trial registries in the US (www.clinicaltrials.gov), Europe (www.clinicaltrialsregister.eu) and Australia/New Zealand (www.anzctr.org.au).