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A big breakthrough for tiny patients

Fresenius Kabi supports groundbreaking research into safer blood transfusions for extremely premature newborns.

The birth of a child is one of the most powerful and emotional experiences in life. But when a baby arrives too soon, it often marks the beginning of an intensive medical journey, filled with uncertainty and risk. For the smallest and most fragile of these infants – those born before 28 weeks of gestation, so called extremely low gestational age neonates (ELGANs) – the first weeks of life are a race for survival. These newborns face a high risk of complications such as bronchopulmonary dysplasia (chronic lung disease) and retinopathy of prematurity (a potentially blinding eye disorder).

Premature newborn lying in an incubator in a neonatal intensive care unit, connected to various life-support and monitoring devices.

In response to this urgent challenge, a team of researchers at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy, is exploring a promising approach: using red blood cells from umbilical cord blood instead of adult donor blood in transfusions for these infants. Fresenius Kabi is proud to support this important study by contributing essential technical expertise, specialized equipment, and hands-on support at every step.

Rethinking Transfusions for Premature Infants

ELGANs often develop anemia and require multiple blood transfusions. Typically, these transfusions use red blood cells from adult donors. However, adult red blood cells differ from those of fetuses in one important way: the type of hemoglobin they contain.

Fetal hemoglobin is designed to release oxygen more slowly to tissues – a characteristic that better suits the physiology of a developing fetus. When premature infants receive adult blood, the faster oxygen release may overwhelm their delicate tissues and contribute to complications.

Dr. Luciana Teofili, a hematologist at Gemelli hospital, was intrigued by the idea of using red blood cells from cord blood – naturally rich in fetal hemoglobin – for neonatal transfusions.

"The concept was promising, but no clinical trial had ever tested it." she says. Together with neonatologist Dr. Patrizia Papacci and her team, Dr. Teofili set out to change that.

Prof. Luciana Teofili smiling, dressed in a white lab coat and blue turtleneck sweater, standing in front of a glass partition with a visible clinical or laboratory environment in the background, where healthcare personnel are working at computer stations
Prof. Luciana Teofili Transfusion Medicine Department, Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore

Their early feasibility study in 2015 laid the groundwork. 

"We wanted to explore whether using cord blood could preserve fetal hemoglobin levels and reduce the risks associated with adult blood transfusions."  says Dr. Papacci. But advancing this idea into a large-scale clinical trial required more than scientific ambition.

Prof. Patrizia Papacci dressed in a white lab coat and blue scrubs, standing in front of a glass partition with a view into a clinical or laboratory setting, where medical staff are working at computer stations in the background.
Prof. Patrizia Papacci Neonatal Intensive Care Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore

Partnering to Make Innovation Possible

Preparing cord blood for transfusion presents significant technical challenges. Cord blood donations are much smaller in volume than adult donations, and until now, the red blood cells in cord blood were typically discarded, while only the stem cells were preserved for use in transplants.

What was needed was a safe, scalable method for collecting, testing, and storing red blood cells from cord blood in a form suitable for neonates. This is where Fresenius Kabi stepped in as a partner. Our experts worked hand-in-hand with the research team to develop and standardize the preparation process. Equipment like the CompoMat G5 blood separator, non-DEHP blood bags, and the BioR flex filter from our portfolio were key components. Fresenius Kabi also provided training and on-site support to eight participating neonatal intensive care units across Italy. 

Dr. Teofili says: "Fresenius Kabi didn’t just supply equipment. They listened, they understood the scientific rationale, and they were present throughout the study to help each center apply the methods correctly. That level of collaboration was exceptional."

A study fueled by hope and trust

The families of the tiny patients have also shown tremendous support. “We haven’t had a single parent refuse participation,” Dr. Teofili notes. “They trust us with the hope that this research can help not only their children but many others in the future.”

For the clinicians involved, the motivation is deeply personal. “Disabilities caused by complications of extreme prematurity can change families’ lives forever,” says Dr. Papacci. “If we can reduce or even eliminate some of these outcomes through a different transfusion approach, it would be a breakthrough.”

As the study progresses, it carries with it the promise of improving care for ELGANs worldwide. “There was a time when saving babies born at 33 or 34 weeks was our biggest challenge,” says Dr. Papacci. “Now, we’re giving babies born at 23 weeks a real chance – not just to survive, but to thrive.” Dr. Teofili agrees: “We are grateful to Fresenius Kabi for believing in us. This collaboration has shown what’s possible when clinicians and industry work together to push the boundaries of patient care.”

Prof. Luciana Teofili and Prof. Patrizia Papacci in white lab coats standing in front of a glass wall with a clinical setting and staff visible in the background.
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