Congenital Diaphragmatic HerniaNCT06739356
North American Fetal Therapy Network for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
A study testing Fetal Treatment arm (FETO Group) in people with Congenital Diaphragmatic Hernia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate successful placement and removal of Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with Observed/Expected (O/E) Lung to Head Circumference Ratio (LHR) < 30% or isolated… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- Fetal Treatment arm (FETO Group)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2025to 1 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women who are able to consent
- Singleton pregnancy
- Normal Karyotype, chromosomal microanalysis (CMA) with non-pathologic variants, Whole exome sequencing (WES) or whole genome sequencing (WGS) . Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
- Gestational age at enrollment is prior to 296 wks.
- Intrathoracic liver herniation
- Isolated left CDH with o/e LHR < 30% at enrollment (180 to 295 wks.). or
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- Isolated RCDH with o/e LHR < 45% at enrollment (180 to 295 wks.)
- Cervical length by transvaginal ultrasound > 20 mm within 24 hours prior to FETO procedure
- Patient meets psychosocial criteria
- Informed consent understood
Who cannot join
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (<20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa.
- Psychosocial ineligibility, precluding consent:
- Inability to reside within 30 minutes of University of Texas Health Science Center at Houston Fetal Center
- The patient does not have a support person (e.g., spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at UTHealth Houston Fetal Center
- Bilateral CDH, isolated left sided CDH with O/E LHR ≥ 30% (measured at 180 to 295 weeks), isolated right sided CDH with O/E LHR > 45% (measured at 180 to 295 weeks), as determined by ultrasound
Show all 16Show fewer
- No liver herniation into thoracic cavity
- Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., CDH and congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns).
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- History of incompetent cervix with or without cerclage
- Placental abnormalities (previa, abruption, accreta) known at time of enrollment
- Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
- Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
- Uterine anomalies such as large or multiple fibroids or Mullerian duct abnormality
- There is no safe or technically feasible fetoscopic approach to balloon placement
- Participation in another intervention study that influences maternal and fetal morbidity and mortality. or participation in this trial in a previous pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Anthony Johnson, DO, (713) 500-5859, Anthony.Johnson@uth.tmc.edu
Elisa P Garcia, (713) 500-7434, Elisa.I.Garcia@uth.tmc.edu
About this study
Official title: North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
The purpose of this study is to evaluate successful placement and removal of Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with Observed/Expected (O/E) Lung to Head Circumference Ratio (LHR) < 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR < 45%,to compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR < 30% that receive FETO procedure performed at 27 weeks 0 days to 29weeks 6 days of gestation to those with intrathoracic liver herniation, isolated LCDH and o/e LRH < 30% that undergo expectant management, to compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCHD with o/e LHR < 45% that undergo FETO procedure performed at 27 weeks 0 days to 29 weeks 6 days gestation to those with intrathoracic liver herniation, isolated RCHD and o/e LHR < 45% that elect to proceed with expectant management, to evaluate the frequency of maternal and fetal complications associated with FETO procedure, to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated LCDH survivors with o/e LHR <30% when compared to isolated LCDH with o/e LRH <30% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation and to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated RCDH survivors with o/e LHR ≤ 45% when compared to isolated RCHD with LHR < 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation
- Conditions
- Congenital Diaphragmatic Hernia
- Being tested
- Fetal Treatment arm (FETO Group)
- Keywords
- Fetoscopic Endoluminal Tracheal Occlusion
- Medical subject headings
- Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Treatment arm (FETO Group)Device
Participants will undergo FETO surgery at at 27 weeks 0 days - 29 weeks 6 days gestation.Balloon insertion into the fetal trachea will be performed. This will be followed by weekly \ ultrasound monitoring and MRI at 3 weeks following FETO insertion and removal of the balloon which will be performed at at 34 weeks 0 days to 34 weeks 6 days. Planned delivery will occur after 37 weeks. The follow-up phase will be conducted from birth to 24 months of age
| Study group | Role | What they receive |
|---|---|---|
| Fetal Treatment arm (FETO Group) | Experimental | Not described Receives: Device: Fetal Treatment arm (FETO Group) |
| Expectant Management Arm (Control Group) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of neonates that survived
Measured: from delivery to hospital discharge (up to 12 months)
Number of Successful placement of FETO device
Measured: 10-60 minutes after surgery begins
Number of Successful removal of FETO device
Measured: immediately after the procedure (about 1 hour after start of surgery)
FETO procedure complications
Complications include, Failure FETO insertion procedure, FETO device dislodgement potentially requiring a second FETO insertion, Fetal intraoperative injury, Procedural hemorrhage, Bleeding from insertion site or Abruptions, Post-procedural hemorrhage PPROM, Preterm delivery, Chorioamnion separation,Chorioamnionitis, Polyhydramnios, Oligohydramnios,Emergent removal due to obstetrical complication, Failed percutaneous or fetoscopic removal requiring cesarean section or exit procedure for removal, Neonatal death due to asphyxia if delivery before FETO removal and Non-reassuring fetal heart rate monitoring
Measured: end of study (24 months)
Secondary outcomes (48)
Number of infants that survived
Measured: 6 months
Number of infants that survived
Measured: 12 months
Number of infants that survived
Measured: 18 months
Number of infants that survived
Measured: 24 months
Number of infants that show presence of pulmonary hypertension
Measured: 6 months
Number of infants that show presence of pulmonary hypertension
Measured: 12 months
Number of infants that show presence of pulmonary hypertension
Measured: 18 months
Number of infants that show presence of pulmonary hypertension
Measured: 24 months
Number of infants that show need for supplemental oxygen
Measured: 6 months
Number of infants that show need for supplemental oxygen
Measured: 12 months
Number of infants that show need for supplemental oxygen
Measured: 18 months
Number of infants that show need for supplemental oxygen
Measured: 24 months
Number of infants that show periventricular leukomalacia
Measured: at less than 2 months postnatally
Number of Infants that develop sepsis
Measured: 6 months
Number of Infants that develop sepsis
Measured: 12 months
Number of Infants that develop sepsis
Measured: 18 months
Number of Infants that develop sepsis
Measured: 24 months
Number of infants that develop Intraventricular hemorrhage (grade 0-III)
Measured: 6 months
Number of infants that develop Intraventricular hemorrhage (grade 0-III)
Measured: 12 months
Number of infants that develop Intraventricular hemorrhage (grade 0-III)
Measured: 18 months
Number of infants that develop Intraventricular hemorrhage (grade 0-III)
Measured: 24 months
Number of infants that develop retinopathy of prematurity (grade 3 or higher)
Measured: 6 months
Number of infants that develop retinopathy of prematurity (grade 3 or higher)
Measured: 12 months
Number of infants that develop retinopathy of prematurity (grade 3 or higher)
Measured: 18 months
Number of infants that develop retinopathy of prematurity (grade 3 or higher)
Measured: 24 months
Number of infants that develop gastro-esophageal reflux
Measured: 6 months
Number of infants that develop gastro-esophageal reflux
Measured: 12 months
Number of infants that develop gastro-esophageal reflux
Measured: 18 months
Number of infants that develop gastro-esophageal reflux
Measured: 24 months
Number of infant hospital readmissions
Measured: end of study (24 months)
Cause of infant hospital readmissions
Measured: end of study (24 months)
Number of infants that show childhood growth failure
Measured: 6 months
Number of infants that show childhood growth failure
Measured: 12 months
Number of infants that show childhood growth failure
Measured: 18 months
Number of infants that show childhood growth failure
Measured: 24 months
Number of infants that show recurrence of CDH repair
Measured: 6 months
Number of infants that show recurrence of CDH repair
Measured: 12 months
Number of infants that show recurrence of CDH repair
Measured: 18 months
Number of infants that show recurrence of CDH repair
Measured: 24 months
Number of infants that develop bowel obstruction
Measured: 6 months
Number of infants that develop bowel obstruction
Measured: 12 months
Number of infants that develop bowel obstruction
Measured: 18 months
Number of infants that develop bowel obstruction
Measured: 24 months
Number of infants that show neurodevelopmental delay as assessed by the Bayley Scales of Infant and Toddler Development-III(BSID)
Three domains will be measured as follows: Cognitive Scale, Language Scale (Receptive and Expressive) and Motor Scale (Fine and Gross Motor Skills). Scores are derived by converting raw scores from completed tasks into scale scores and composite scores. These scores are then utilized to assess the child's performance in relation to norms established based on typically developing children of the same age
Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning.
Scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.
Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.
In general, scores falling in the lowest 10th percentile indicate developmental delay
Measured: 24 months
Number of infants that develop bronchopulmonary dysplasia
Measured: 6 months
Number of infants that develop bronchopulmonary dysplasia
Measured: 12 months
Number of infants that develop bronchopulmonary dysplasia
Measured: 18 months
Number of infants that develop bronchopulmonary dysplasia
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start4 Mar 2025
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Johnson, The University of Texas Health Science Center, Houston
- Investigators
- Anthony Johnson, DO, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739356
- Sponsor's protocol ID
- HSC-MS-24-0984
- Status last verified
- Oct 2026
- First submitted
- 9 Dec 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT06739356
- Acronym / sponsor ID
- HSC-MS-24-0984
- Conditions
- Congenital Diaphragmatic Hernia
- Keywords
- Fetoscopic Endoluminal Tracheal Occlusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate successful placement and removal of Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with Observed/Expected (O/E) Lung to Head Circumference Ratio (LHR) < 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR < 45%,to compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR < 30% that receive FETO procedure performed at 27 weeks 0 days to 29weeks 6 days of gestation to those with intrathoracic liver herniation, isolated LCDH and o/e LRH < 30% that undergo expectant management, to compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCHD with o/e LHR < 45% that undergo FETO procedure performed at 27 weeks 0 days to 29 weeks 6 days gestation to those with intrathoracic liver herniation, isolated RCHD and o/e LHR < 45% that elect to proceed with expectant management, to evaluate the frequency of maternal and fetal complications associated with FETO procedure, to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated LCDH survivors with o/e LHR <30% when compared to isolated LCDH with o/e LRH <30% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation and to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated RCDH survivors with o/e LHR ≤ 45% when compared to isolated RCHD with LHR < 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fetal Treatment arm (FETO Group) | Experimental | Device: Fetal Treatment arm (FETO Group) |
| Expectant Management Arm (Control Group) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pregnant women who are able to consent
- Singleton pregnancy
- Normal Karyotype, chromosomal microanalysis (CMA) with non-pathologic variants, Whole exome sequencing (WES) or whole genome sequencing (WGS) . Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
- Gestational age at enrollment is prior to 296 wks.
- Intrathoracic liver herniation
Key exclusion criteria (16 listed)
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (<20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa.
- Psychosocial ineligibility, precluding consent:
- Bilateral CDH, isolated left sided CDH with O/E LHR ≥ 30% (measured at 180 to 295 weeks), isolated right sided CDH with O/E LHR > 45% (measured at 180 to 295 weeks), as determined by ultrasound
- No liver herniation into thoracic cavity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal Treatment arm (FETO Group)Participants will undergo FETO surgery at at 27 weeks 0 days - 29 weeks 6 days gestation.Balloon insertion into the fetal trachea will be performed. This will be followed by weekly \ ultrasound monitoring and MRI at 3 weeks following FETO insertion and removal of the balloon which will be performed at at 34 weeks 0 days to 34 weeks 6 days. Planned delivery will occur after 37 weeks. The follow-up phase will be conducted from birth to 24 months of age | Device | Fetal Treatment arm (FETO Group) |
Primary outcome
Number of neonates that survived
Time frame: from delivery to hospital discharge (up to 12 months)
Number of Successful placement of FETO device
Time frame: 10-60 minutes after surgery begins
Number of Successful removal of FETO device
Time frame: immediately after the procedure (about 1 hour after start of surgery)
FETO procedure complications
Time frame: end of study (24 months)
Complications include, Failure FETO insertion procedure, FETO device dislodgement potentially requiring a second FETO insertion, Fetal intraoperative injury, Procedural hemorrhage, Bleeding from insertion site or Abruptions, Post-procedural hemorrhage PPROM, Preterm delivery, Chorioamnion separation,Chorioamnionitis, Polyhydramnios, Oligohydramnios,Emergent removal due to obstetrical complication, Failed percutaneous or fetoscopic removal requiring cesarean section or exit procedure for removal, Neonatal death due to asphyxia if delivery before FETO removal and Non-reassuring fetal heart rate monitoring
48 secondary outcomes
Number of infants that survived
Time frame: 6 months
Number of infants that survived
Time frame: 12 months
Number of infants that survived
Time frame: 18 months
Number of infants that survived
Time frame: 24 months
Number of infants that show presence of pulmonary hypertension
Time frame: 6 months
Number of infants that show presence of pulmonary hypertension
Time frame: 12 months
Number of infants that show presence of pulmonary hypertension
Time frame: 18 months
Number of infants that show presence of pulmonary hypertension
Time frame: 24 months
Number of infants that show need for supplemental oxygen
Time frame: 6 months
Number of infants that show need for supplemental oxygen
Time frame: 12 months
Number of infants that show need for supplemental oxygen
Time frame: 18 months
Number of infants that show need for supplemental oxygen
Time frame: 24 months
Number of infants that show periventricular leukomalacia
Time frame: at less than 2 months postnatally
Number of Infants that develop sepsis
Time frame: 6 months
Number of Infants that develop sepsis
Time frame: 12 months
Number of Infants that develop sepsis
Time frame: 18 months
Number of Infants that develop sepsis
Time frame: 24 months
Number of infants that develop Intraventricular hemorrhage (grade 0-III)
Time frame: 6 months
Number of infants that develop Intraventricular hemorrhage (grade 0-III)
Time frame: 12 months
Number of infants that develop Intraventricular hemorrhage (grade 0-III)
Time frame: 18 months
Number of infants that develop Intraventricular hemorrhage (grade 0-III)
Time frame: 24 months
Number of infants that develop retinopathy of prematurity (grade 3 or higher)
Time frame: 6 months
Number of infants that develop retinopathy of prematurity (grade 3 or higher)
Time frame: 12 months
Number of infants that develop retinopathy of prematurity (grade 3 or higher)
Time frame: 18 months
Number of infants that develop retinopathy of prematurity (grade 3 or higher)
Time frame: 24 months
Number of infants that develop gastro-esophageal reflux
Time frame: 6 months
Number of infants that develop gastro-esophageal reflux
Time frame: 12 months
Number of infants that develop gastro-esophageal reflux
Time frame: 18 months
Number of infants that develop gastro-esophageal reflux
Time frame: 24 months
Number of infant hospital readmissions
Time frame: end of study (24 months)
Cause of infant hospital readmissions
Time frame: end of study (24 months)
Number of infants that show childhood growth failure
Time frame: 6 months
Number of infants that show childhood growth failure
Time frame: 12 months
Number of infants that show childhood growth failure
Time frame: 18 months
Number of infants that show childhood growth failure
Time frame: 24 months
Number of infants that show recurrence of CDH repair
Time frame: 6 months
Number of infants that show recurrence of CDH repair
Time frame: 12 months
Number of infants that show recurrence of CDH repair
Time frame: 18 months
Number of infants that show recurrence of CDH repair
Time frame: 24 months
Number of infants that develop bowel obstruction
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Congenital Diaphragmatic Hernia
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
RecruitingPhase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)
Congenital Diaphragmatic Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony Johnson, DO principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal Treatment arm (FETO Group) in people with Congenital Diaphragmatic Hernia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony Johnson, DO ((713) 500-5859, Anthony.Johnson@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of neonates that survived (time frame: from delivery to hospital discharge (up to 12 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.