Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH)

Inclusion Criteria:

- Diagnosis of CDH between 20 and 36 weeks estimated gestational age (EGA)

- Only one of the following fetal criteria and one of the following postnatal criteria
must be met for enrollment. Fetal criteria: an ultrasound (US)-obtained observed to
expected lung to head ratio (o/e LHR) less than or equal to 35% or 2) a fetal magnetic
resonance imaging (fMRI)- obtained observed to expected total fetal lung volume (o/e
TFLV) less than or equal to 35%. Postnatal criteria: 1) Cord blood gas (CBG) with
potenital hydrogen (pH) <7.0, 2) Arterial blood gas (ABG) with pH <7.2 on 2 gasses
within the first 24 hours, 3) Preductal oxygen saturation (O2 sat) <90% x 2 total
hours (not necessarily consecutive) within the first 24 hours, or 4) Oxygenation Index
(OI) >20 x 2 total hours (not necessarily consecutive) within the first 24 hours.

Exclusion Criteria:

- Genetic/chromosomal abnormality: Trisomy 21, Trisomy 18, Trisomy 13 or other,
significant genetic abnormality. Microdeletions or other mild genetic abnormalities
are not considered exclusionary.

- Severe/major cardiac anomaly: coarctation of the aorta, combined atrial and
ventricular septal defects, hypoplastic left heart syndrome, tetralogy of fallot,
double outlet right ventricle, atrioventricular canal defects, or other
hemodynamically significant defects.

- Moderate/severe neurologic / intracranial abnormality: Grade III or IV
intraparenchymal hemorrhage, space occupying mass or lesion, or clinically significant
traumatic lesion such as a subdural or epidural hemorrhage.

- Prematurity <30 weeks estimated gestational age (EGA): Birth at 29 6/7 weeks or before

- Participation in an alternative prenatal intervention study: Fetoscopic Endotracheal
Occlusion (FETO)

- Unwillingness / inability to return for follow-up evaluation and assessment