A newborn in Sweden became the first baby in the world to be born into a global clinical trial testing a drug that could prevent fetal and neonatal alloimmune thrombocytopenia (FNAIT), according to a press release published recently by Karolinska University Hospital, who is conducting the study.
FNAIT, a rare but dangerous disorder in which a pregnant person’s immune system attacks the baby’s platelets, can lead to severe bleeding and, in some cases, a type of fetal anemia. The FREESIA-1 study aims to stop the condition before it starts.
The baby was delivered at 6:07 AM on April 29 at Karolinska University Hospital in Huddinge, which is leading the trial in collaboration with a pharmaceutical company. The international study is testing whether the drug nipocalimab can block harmful antibodies in the mother’s blood from reaching the fetus. This could prevent the immune system from destroying the baby’s platelets or red blood cells.
“It’s rare to see clinical drug trials that target the fetus during pregnancy, so this represents a major leap forward,” said Dr. Gunilla Ajne, a senior consultant at Karolinska and one of the study’s lead researchers.
Read more about treatment and care of FNAIT
FNAIT is uncommon, but it can become serious. About 0.5% of pregnancies involve antibodies that may harm the fetus, and roughly 0.1% result in FNAIT. The condition increases the risk of brain or other organ bleeding before or during birth. It may also cause hemolytic disease of the fetus and newborn (HDFN), where red blood cells are broken down.
In Sweden, Karolinska serves as the national center for fetal transfusions, which is an advanced procedure that treats fetal anemia by delivering blood directly to the unborn baby. These transfusions are repeated every two weeks and often require families to travel long distances. If nipocalimab works, it could offer a simpler, earlier, and less invasive option.
“It’s an incredible milestone that we now have the first baby in the world born within the framework of this study—and both mother and child are doing well,” said Dr. Ajne,
The FREESIA-1 trial includes about 15 countries in Europe, the Americas and Canada. Karolinska expects to enroll three women in this phase, and several more in a follow-up focused on red blood cell protection. Researchers hope the results will change how rare fetal conditions such as FNAIT are managed worldwide, thereby making treatment safer, more effective and more accessible to families.
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