Fetal Hemoglobin Levels and Umbilical Cord or Adult Blood RBC Transfusions in Preterm Neonates.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Median Percentage of HbF at 32 Weeks of Post Menstrual Age
Study Overview
Brief Summary
Repeated transfusions have been associated with very poor outcome of preterm infants. Fetal hemoglobin (HbF) and adult Hb (HbA) have different affinity for oxygen. The high level of adult Hb may contribute to exacerbating the oxidative damage responsible for prematurity diseases. The investigators hypothesized that transfusing red blood cells (RBC) obtained from allogeneic cord blood (CB) of healthy full-term babies (which contains almost exclusively HbF) may prevent the non-physiological decrease of HbF in premature neonates, likewise protecting them from oxygen radical diseases. Cord blood transfusion in preterms - CB TRIP - is a monocentric prospective nonrandomized study aimed to monitor HbF levels in preterm neonates receiving RBC transfusions from either umbilical blood of full-term healthy babies (CB-RBC) and/or from adult donors (A-RBC).
Detailed Description
Preterm neonates enrolled in this study are monitored for the level of HbF on capillary blood samples, from birth to the week 32 of postmenstrual age (PMA). To fulfill the RBC transfusion requirements, RBC concentrates obtained from umbilical blood of full-term healthy babies are utilized, if available; otherwise, RBC concentrates from adult donors are assigned. For every week of PMA, neonates undergo a minimum of three HbF determinations, and the median values are considered.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •preterm neonates born at PMA ≤30 weeks and/or with birth weight ≤1000 g born at the delivery room of Fondazione Policlinico Universitario A. Gemelli candidate to receive one or more RBC unit transfusion.
Exclusion Criteria
- •One or more of the following criteria Maternal-fetal immunization Hydrops fetalis Major congenital malformations associated or not with genetic syndromes Previous transfusions Hemorrhage at birth Congenital infections (such as infections from TORCH complex) Out-born infants The health care team deems it inappropriate to approach the infant's family for informed consent
Outcomes
Primary Outcomes
Median Percentage of HbF at 32 Weeks of Post Menstrual Age
Time Frame: From study entry to the completion of postmenstrual age of 32 weeks
The HbF level was determined by high-performance liquid chromatography and was expressed as percentage of total Hb, calculated as the sum of fetal and adult Hb, according to the formula: HbF= \[HbF/ (FHbA1 + HbA2 + HbF)\]. HbF.
Secondary Outcomes
- Intervals Between Transfusions(From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death)
- Median Percentage of HbF at Last Assessment(From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death)
- Post-transfusion Hematocrit (Htc) Change(From enrollment to last HbF assessment occurring at 36 weeks, discharge or death)
Investigators
TEOFILI LUCIANA
Medical Director of the UNICATT Cord Blood Bank
Fondazione Policlinico Universitario Agostino Gemelli IRCCS