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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2027
  • participants needed
    20
  • sponsor
    The University of Texas Health Science Center, Houston
Updated on 18 April 2022
mononuclear cells
arterial blood gas
diaphragmatic hernia

Summary

The purpose of this study is to investigate the use of autologous umbilical cord blood (UCB) mononuclear cells to mitigate hypoxic neurologic injury among infants with high-risk congenital diaphragmatic hernia (CDH).

Details
Condition Congenital Diaphragmatic Hernia
Treatment Autologous Umbilical Cord Blood
Clinical Study IdentifierNCT03526588
SponsorThe University of Texas Health Science Center, Houston
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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