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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2022
• Main ID: NCT03526588
• Date of registration: 27/04/2018
• Prospective Registration: Yes
• Primary sponsor: The University of Texas Health Science Center, Houston
• Public title: Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH)
• Scientific title: Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH)
• Date of first enrolment: August 1, 2018
• Target sample size: 20
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03526588
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Matthew T. Harting, MD, MS
• Affiliation: The University of Texas Health Science Center, Houston

• Name: Matthew T Harting, MD, MS

• Name: Matthew T. Harting, MD, MS

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: 7 Days
Gender: All

Health Condition(s) or Problem(s) studied

Congenital Diaphragmatic Hernia

Intervention(s)

Biological: Autologous umbilical cord blood

Primary Outcome(s)

Safety as assessed by carbon dioxide (CO2) levels [Time Frame: 7 days following the initial infusion]

Safety as assessed by serum chloride levels [Time Frame: 7 days following the initial infusion]

Safety as assessed by blood urea nitrogen (BUN) levels [Time Frame: 7 days following the initial infusion]

Safety as assessed by cardiovascular status (indicated by changes in cardiovascular pharmacologic support) [Time Frame: daily for 7 days following the initial infusion]

Safety as assessed by cardiovascular status (indicated by heart rate) [Time Frame: daily for 7 days following the initial infusion]

Safety as assessed by infection status (indicated by body temperature) [Time Frame: daily for 7 days following the initial infusion]

Safety as assessed by infection status (indicated by physical signs of infection) [Time Frame: daily for 7 days following the initial infusion]

Safety as assessed by presence of new infiltrates or altered aeration upon chest radiography [Time Frame: daily for 7 days following the initial infusion]

Safety as assessed by pulmonary status (indicated by positive end expiratory pressure (PEEP)) [Time Frame: daily for 7 days following the initial infusion]

Neurologic/neurodevelopmental status as assessed by Bayley Scales of Infant and Toddler Development-III (BSID-III) [Time Frame: 2 years after birth]

Safety as assessed by pulmonary status (indicated by respiratory rate (RR)) [Time Frame: daily for 7 days following the initial infusion]

Neurologic/neurodevelopmental status as assessed by receipt of neurologic pharmacologic medications [Time Frame: at the time of discharge (which is about 2-4 months after birth)]

Neurologic/neurodevelopmental status as assessed by intracranial abnormalities upon magnetic resonance imaging (MRI) [Time Frame: within 14 days of discharge (discharge occurs at about 2-4 months after birth)]

Safety as assessed by cardiovascular status (indicated by systolic blood pressure) [Time Frame: daily for 7 days following the initial infusion]

Safety as assessed by liver function (indicated by Alanine aminotransferase (ALT) levels) [Time Frame: 7 days following the initial infusion]

Safety as assessed by creatinine levels [Time Frame: 7 days following the initial infusion]

Safety as assessed by infection status (indicated by white blood cell count) [Time Frame: 7 days following the initial infusion]

Safety as assessed by vital sign monitoring (temperature) [Time Frame: daily for 7 days following the initial infusion]

Safety as assessed by pulmonary status (indicated by Fraction of inspired oxygen (FiO2)) [Time Frame: daily for 7 days following the initial infusion]

Safety as assessed by cardiovascular status (indicated by diastolic blood pressure) [Time Frame: daily for 7 days following the initial infusion]

Safety as assessed by glucose levels [Time Frame: 7 days following the initial infusion]

Safety as assessed by liver function (indicated by aspartate aminotransferase (AST) levels [Time Frame: 7 days following the initial infusion]

Safety as assessed by liver function (indicated by albumin levels) [Time Frame: 7 days following the initial infusion]

Safety as assessed by liver function (indicated by bilirubin levels) [Time Frame: 7 days following the initial infusion]

Safety as assessed by pulmonary status (indicated by peak inspiratory pressure (PIP)) [Time Frame: daily for 7 days following the initial infusion]

Safety as assessed by vital sign monitoring (systolic blood pressure) [Time Frame: daily for 7 days following the initial infusion]

Safety as assessed by serum potassium levels [Time Frame: 7 days following the initial infusion]

Safety as assessed by serum sodium levels [Time Frame: 7 days following the initial infusion]

Safety as assessed by vital sign monitoring (heart rate) [Time Frame: daily for 7 days following the initial infusion]

Safety as assessed by vital sign monitoring (diastolic blood pressure) [Time Frame: daily for 7 days following the initial infusion]

Secondary Outcome(s)

Duration of ventilatory support [Time Frame: from initiation of ventilation until extubation (an average of 8 weeks)]

Length of stay in hospital [Time Frame: from birth to discharge or death, whichever occurs first (discharge occurs at about 2-4 months after birth)]

Mortality [Time Frame: 2 years after birth]

Duration of extracorporeal membrane oxygenation (ECMO) support [Time Frame: days from ECMO initiation until decannulation (an average of 3 weeks)]

Progression of pulmonary hypertension as assessed by echocardiography [Time Frame: within 24 hours of birth, prior to operative repair (occurs between day 2 & 14 of life), prior to discharge (usually 2-6 months), and after discharge (2wks-6 months following discharge)]

Secondary ID(s)

HSC-MS-18-0148

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Texas Medical Center Regenerative Medicine Consortium