Trials / Completed
CompletedNCT03764813
Cord Blood Transfusion In Preterm Neonates (CB-TrIP)
Fetal Hemoglobin Levels and Umbilical Cord or Adult Blood RBC Transfusions in Preterm Neonates.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (actual)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2018-12-05
- Primary completion
- 2019-08-02
- Completion
- 2019-08-02
- First posted
- 2018-12-05
- Last updated
- 2021-08-17
- Results posted
- 2020-04-24
Locations
2 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT03764813. Inclusion in this directory is not an endorsement.