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 range

10 Minutes – 7 Days

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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))

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 range

10 Minutes – 7 Days

Sex

ALL

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))