The purpose of this non-interventional study is to prospectively evaluate the risk of anemia (decreased red blood cells) in fetuses (baby before birth) and neonates (baby just after birth) of pregnant participants who are at risk for hemolytic disease of the fetus and newborn (HDFN) and receiving standard of care (SoC). HDFN is a blood disease that occurs in babies before birth or just after birth when the blood types of the pregnant individual and babies are incompatible, thus resulting in fast breakdown of red blood cells (RBCs) of the fetus/baby.

A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry

Hemolytic Disease of the Fetus and Newborn

HDFN

Autoantibody diseases

Immune system conditions

Standard of Care

Global Prospective Hemolytic Disease of the Fetus and Newborn Registry

Percentage of pregnancies that did not result in fetal loss (due to any reason), IUT, hydrops fetalis, or neonatal death (due to any reason) during the neonatal period will be reported. Hydrops fetalis is defined as the presence of greater than or equal to (>=) 2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness greater than [>] 5 millimeter [mm]). Post-menstrual age (PMA) is the time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (chronological age).

Number of participants in each HDFN severity index category will be reported. The severity of HDFN is defined as: 5 (fatal): fetal or neonatal death due to any reason; 4 (severe): hydrops fetalis (in fetus or newborn) or receiving IUT during pregnancy as a result of HDFN but not 5 (fatal); 3 (moderate): neonatal exchange transfusions received as a result of HDFN related hemolysis and jaundice but not 4 (severe) or 5 (fatal); 2 (mild): neonatal simple transfusions received due to HDFN after birth, with or without phototherapy, but not 3 (moderate), 4 (severe), or 5 (fatal); and 1 (minimal or none): not in 2 (mild), 3 (moderate), 4 (severe), or 5 (fatal) as described above. HDFN requiring phototherapy will be classified in this category.

Time to first occurrence of IUT or hydrops fetalis will be reported.

The mNMMI will be assessed with the following categories: fatal: neonatal death; major morbidity: any of intraventricular hemorrhage grade 3/4, seizures, hypoxic-ischemic encephalopathy, necrotizing enterocolitis stage 2/3, respiratory distress syndrome requiring mechanical ventilation, bronchopulmonary dysplasia requiring oxygen support, or persistent pulmonary hypertension; Minor morbidity: anemia requiring simple transfusion, hyperbilirubinemia requiring an exchange transfusion, hypotension requiring treatment, intraventricular hemorrhage grade 1/2, necrotizing enterocolitis stage 1, or respiratory distress syndrome not requiring mechanical ventilation; None: no major or minor morbidities described above. Hyperbilirubinemia requiring phototherapy will be classified in this category.

Number of IUT's received during the pregnancy will be reported.

Pregnant participants with a risk for HDFN in their current pregnancy will be enrolled. No treatment will be provided by the sponsor as a part of this study. Only data will be collected for participants for the duration of their pregnancy and for 2 years following birth for their corresponding neonate/infant/child. Data will be collected from eligible participants at medical centers that routinely diagnose and treat pregnant participants with HDFN. Additionally, participants will be asked to complete versions of clinical outcome assessments (Patient-reported outcomes [PROs]/Observer-reported outcomes [ObsROs]) at specific times throughout follow-up. Data collection will be considered complete for eligible participants if all available data have been recorded in the electronic case report form (eCRF).

The purpose of this non-interventional study is to prospectively evaluate the risk of
anemia (decreased red blood cells) in fetuses (baby before birth) and neonates (baby just
after birth) of pregnant participants who are at risk for hemolytic disease of the fetus
and newborn (HDFN) and receiving standard of care (SoC). HDFN is a blood disease that
occurs in babies before birth or just after birth when the blood types of the pregnant
individual and babies are incompatible, thus resulting in fast breakdown of red blood
cells (RBCs) of the fetus/baby.

Baylor College of Medicine

Fondazione Policlinico Universitario A Gemelli IRCCS

Percentage of pregnancies that did not result in fetal loss (due to any reason), IUT,
hydrops fetalis, or neonatal death (due to any reason) during the neonatal period will be
reported. Hydrops fetalis is defined as the presence of greater than or equal to (>=) 2
abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions,
pericardial effusion, and generalized skin edema (skin thickness greater than [>] 5
millimeter [mm]). Post-menstrual age (PMA) is the time elapsed between the first day of
the last menstrual period and birth (gestational age) plus the time elapsed after birth
(chronological age).

Number of participants in each HDFN severity index category will be reported. The
severity of HDFN is defined as: 5 (fatal): fetal or neonatal death due to any reason; 4
(severe): hydrops fetalis (in fetus or newborn) or receiving IUT during pregnancy as a
result of HDFN but not 5 (fatal); 3 (moderate): neonatal exchange transfusions received
as a result of HDFN related hemolysis and jaundice but not 4 (severe) or 5 (fatal); 2
(mild): neonatal simple transfusions received due to HDFN after birth, with or without
phototherapy, but not 3 (moderate), 4 (severe), or 5 (fatal); and 1 (minimal or none):
not in 2 (mild), 3 (moderate), 4 (severe), or 5 (fatal) as described above. HDFN
requiring phototherapy will be classified in this category.

The mNMMI will be assessed with the following categories: fatal: neonatal death; major
morbidity: any of intraventricular hemorrhage grade 3/4, seizures, hypoxic-ischemic
encephalopathy, necrotizing enterocolitis stage 2/3, respiratory distress syndrome
requiring mechanical ventilation, bronchopulmonary dysplasia requiring oxygen support, or
persistent pulmonary hypertension; Minor morbidity: anemia requiring simple transfusion,
hyperbilirubinemia requiring an exchange transfusion, hypotension requiring treatment,
intraventricular hemorrhage grade 1/2, necrotizing enterocolitis stage 1, or respiratory
distress syndrome not requiring mechanical ventilation; None: no major or minor
morbidities described above. Hyperbilirubinemia requiring phototherapy will be classified
in this category.

Pregnant participants with a risk for HDFN in their current pregnancy will be enrolled.
No treatment will be provided by the sponsor as a part of this study. Only data will be
collected for participants for the duration of their pregnancy and for 2 years following
birth for their corresponding neonate/infant/child. Data will be collected from eligible
participants at medical centers that routinely diagnose and treat pregnant participants
with HDFN. Additionally, participants will be asked to complete versions of clinical
outcome assessments (Patient-reported outcomes [PROs]/Observer-reported outcomes
[ObsROs]) at specific times throughout follow-up. Data collection will be considered
complete for eligible participants if all available data have been recorded in the
electronic case report form (eCRF).

A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry

Trials at a glance

Trials at a glance

A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry

Outcome measures

Primary outcome measures

Secondary outcome measures