TerminatedPhase 1

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

Stopped: Competing randomized trial of an experimental therapy limited initial enrollment. The trial was completed, published, and the experimental therapy became broadly desired. Given this, the investigators felt it best to terminate this competing study.

United States3 participantsStarted 2018-08-01

Plain-language 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).

Who can participate

Age range10 Minutes – 7 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 signi…

What they're measuring

Safety as assessed by vital sign monitoring (heart rate)

Timeframe: daily for 7 days following the initial infusion

Safety as assessed by vital sign monitoring (systolic blood pressure)

Timeframe: daily for 7 days following the initial infusion

Safety as assessed by vital sign monitoring (diastolic blood pressure)

Timeframe: daily for 7 days following the initial infusion

Safety as assessed by vital sign monitoring (temperature)

Timeframe: daily for 7 days following the initial infusion

Safety as assessed by pulmonary status (indicated by peak inspiratory pressure (PIP))

Timeframe: daily for 7 days following the initial infusion

Safety as assessed by pulmonary status (indicated by positive end expiratory pressure (PEEP))

Timeframe: daily for 7 days following the initial infusion

Safety as assessed by pulmonary status (indicated by respiratory rate (RR))

Timeframe: daily for 7 days following the initial infusion

Trial details

NCT IDNCT03526588

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-01

View on ClinicalTrials.gov More Congenital Diaphragmatic Hernia trials

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

United States3 participantsStarted 2018-08-01

Who can participate

Age range10 Minutes – 7 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety as assessed by vital sign monitoring (heart rate)

Timeframe: daily for 7 days following the initial infusion

Safety as assessed by vital sign monitoring (systolic blood pressure)

Timeframe: daily for 7 days following the initial infusion

Safety as assessed by vital sign monitoring (diastolic blood pressure)

Timeframe: daily for 7 days following the initial infusion

Safety as assessed by vital sign monitoring (temperature)

Timeframe: daily for 7 days following the initial infusion

Safety as assessed by pulmonary status (indicated by peak inspiratory pressure (PIP))

Timeframe: daily for 7 days following the initial infusion

Safety as assessed by pulmonary status (indicated by positive end expiratory pressure (PEEP))

Timeframe: daily for 7 days following the initial infusion

Safety as assessed by pulmonary status (indicated by respiratory rate (RR))

Timeframe: daily for 7 days following the initial infusion