Stem cells through the nose: a shot at stopping cerebral palsy

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Neonates with a gestational age ≥35.0 weeks at birth * Diagnosed with HIBI on MRI, caused either by PAIS (ORPHA 439175) or PA (ORPHA 137577) diagnosis (will be randomized separately) o PAIS: a neurologic condition characterized by focal cerebral ischemia and infarction following blockage of a brain artery with impairment of blood supply and oxygenation of brain tissue, clinically characterized by seizures (clinical or subclinical), respiratory difficulties, or both (unilateral or bilateral). o PA: defined as at least one out of the following: 5-min Apgar score ≤ 5 * Resuscitation * Mechanical ventilation following resuscitation ≥ 10 minutes after birth * pH \<7.0, BE \<-16 mmol/L, or lactate \> 10.0 mmol/L in umbilical cord blood sample, or in arterial, venous or capillary blood gas sample obtained within 1 hour after birth * Showing signs of hypoxic-ischemic injury in one or more of the following predefined brain areas (indicated by DWI restriction and/or abnormal ADC values and/or 1H-MRS lactate/N-acetyl aspartate (NAA) and/or NAA/Choline ratio abnormalities): * Central gray matter (basal ganglia and/or thalami), and/or * Posterior limb of the internal capsule (PLIC), and/or * Cerebral peduncles, and/or * White matter injury with corticospinal tract (CST) involvement, and/or * Rolandic cortex * Written informed consent from custodial parent(s) Exclusion Criteria: * Suspicion of chromosomal anomaly, metabolic disorder, genetic syndrome, congenital central nervous system (CNS) malformation, congenital CNS infection and main injury intracranial haemorrhage. * Once a clinical team decides on withdrawal of Neonatal Intensive Care Unit (NICU) care, the patient is not eligible for inclusion: infants with very severe brain injury on MRI and need for ventilation support (not breathing independently), who have a prognosis of severe multiple handicaps and/or no realistic prospect of survival at the discretion of the infant's clinical care team in the NICU, will not be eligible for iSTOP-CP, to avoid unnecessary suffering and an unacceptable quality of life. * Contraindications for intranasal administration of medication, nasal obstruction caused by e.g. choanal atresia, nasal septal abnormalities, nasal trauma, epistaxis, excessive nasal mucus or blood, and intranasal obstructive damage.