Congenital Abnormalities, Congenital Diaphragmatic Hernia, Fetal Anomaly, Fetal Surgery, Hernia, Hernia, Diaphragmatic, Hernia, DIaphragmatic, Congenital, Pathological Conditions, Anatomical, Pulmonary Hypoplasia
Conditions
Keywords
CDH, Congenital Diaphragmatic Hernia, Fetal Tracheal Occlusion, FETO, plug-unplug, GoldBal2, Balloon, Goldvalve Balloon, TOTAL
Brief summary
This trial will test whether temporary fetoscopic endoluminal tracheal occlusion (FETO) rather than expectant management during pregnancy, followed by standardized postnatal management, increases survival at discharge and decreases oxygen need at 6 months in case of survival till discharge.
Detailed description
This is a multi-center, non-blinded randomized controlled trial in fetuses with isolated moderate CDH, i.e. moderate lung hypoplasia (as determined by prenatal assessment of lung development). It essentially compares fetal therapy added to conventional postnatal care, versus expectant prenatal management during pregnancy followed by conventional postnatal care. Enrollment: Following completion of an inclusion/exclusion criteria checklist and obtaining informed consent, the subject will be randomized into two groups (FETO and expectant). Procedures: Group I: Standardized postnatal care (expectant group): mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. Group II: Prenatal intervention (FETO group): patients will undergo fetoscopic tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in I. In this study FETO is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days. This study trial is a pragmatical or efficacy trial: ideally mothers will deliver after removal of the balloon at those tertiary centers, typically offering postnatal care for the patient involved. In group II (FETO-group), mothers will, in between placement and removal of the balloon, thus carrying a fetus with obstructed airways, ideally remain under the care of our local fetal treatment center (further referred to as FETO center). As many as possible precautions are taken to avoid problems with balloon removal in case of earlier than expected delivery. * Balloons are to be electively removed prior to 35 weeks. FETO centers will provide 24/24 hours and 7/7 days services for management of fetuses with obstructed airways, either in utero or during labor and delivery. * Patients in the study and randomized to FETO, will be encouraged to stay near the FETO center. After reversal of the occlusion the patient will be referred to the tertiary care center where delivery and postnatal care will be undertaken. If the patient is not remaining at or close to the FETO center, the postnatal treatment center should organize likewise EXIT services.
Interventions
DEVICEGoldBal2 detachable balloon
Placement of the balloon using the plug/unplug method.
DEVICEBaltaccidbpe100 Delivery Catheter
The catheter assists with implanting the balloon in the plug/unplug method.
OTHERStandardized postnatal care
After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622
Sponsors
Baylor College of Medicine
Universitaire Ziekenhuizen KU Leuven
Michael A Belfort
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 years or more, who are able to consent, 2. Singleton pregnancy, 3. Chromosomally normal fetus, 4. Gestation at randomization prior to 31 weeks plus 5 days or so that occlusion is done at the latest on 31 weeks plus 6 days, 5. Fetus is estimated to have moderate pulmonary hypoplasia, defined prenatally as: • O/E LHR 25-34.9% (included; irrespective of the position of the liver) • O/E LHR 35-44.9% (included) with intrathoracic liver herniation as determined by ultrasound or MRI. The O/E LHR will be determined by the FETO centers as follows: * Measurement of the contralateral lung area preferentially by the tracing method at the 4-chamber view of the heart; if by other method adjusted normative ranges must be used. * Measurement of the head circumference at the standard biparietal view of the head * The observed lung area: calculation of the LHR as the ratio of the measurements of the lung area to head circumference * The expected lung area is the lung area of a normal gestational age match, as determined by the head circumference of the index case in a normogram established for the same measurement method (tracing method in this case). A calculator for this will be available on the website of the study. * Calculation of the observed over expected lung area, 6. Acceptance of randomization and the consequences for the further management during pregnancy and thereafter, this includes the required observation following FETO surgery, which lasts up to 4 weeks after balloon is in place, 7. The patients must undertake the responsibility for either remaining close to, or at the FETO center, or being able to travel swiftly and within acceptable time interval to the FETO center until the balloon is removed. Intended postnatal treatment center must subscribe to suggested guidelines for standardized postnatal treatment, and 8. Provide written consent to participate. 9. Fetus with no major anomalies that would impact the clinical course or outcomes.
Exclusion criteria
1. Maternal contraindication to fetoscopic surgery or severe medical condition in pregnancy that make fetal intervention risky, 2. Technical limitations precluding fetoscopic surgery, such as severe maternal obesity, uterine fibroids or potentially others, not anticipated at the time of writing this protocol, 3. Preterm labor, cervix shortened (\<15 mm at randomization) or uterine anomaly strongly predisposing to preterm labor, placenta previa, 4. Patient age less than 18 years, 5. Psychosocial ineligibility, precluding consent, 6. Diaphragmatic hernia: right-sided or bilateral, major anomalies, isolated left-sided outside the O/E LHR limits for the inclusion criteria, and 7. Patient refusing randomization, to comply with required 4-week observation after balloon placement, or to comply with return to FETO center during the time period the airways are occluded or for elective removal of the balloon. 8. Patient allergic to latex.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Neonate Survival at Discharge From Hospital | At hospital discharge, an average of 1.5 months | The null hypothesis to be tested is that there is no difference in survival between fetuses managed expectantly during pregnancy versus those undergoing antenatal therapy (FETO). |
| Participants Requiring Supplemental Oxygen | At 6 months of age | The number of survivors requiring supplemental oxygen at 6 months of age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ECMO (Extracorporeal Membrane Oxygenation) Support | Neonatal period (during the first 4 weeks of life) | Need for extracorporeal membrane oxygenation (ECMO) in the neonatal period |
| CDH Defect Size | Measured in neonate at delivery by MRI and/or ultrasound | Postnatal grade classification (A-D) using CDH study group standardized system with A being the smallest defects and D being the largest defects. A = Defect entirely surrounded by muscle; B = Small (\<50%) portion of the chest wall devoid of diaphragm tissue; C = Large (\>50%) portion of the chest wall devoid of diaphragm tissue; D = Complete or near complete absence of the diaphragm. |
| Number of Days in the NICU | At the time of discharge from the NICU, an average of 1.5 months | Length of stay in the neonatal intensive care unit measured in days |
| Ventilatory Support | During the first 4 weeks of life (neonatal period) | Length of time participants required ventilator support measured in days. |
| Number of Subjects With Periventricular Leukomalacia (PVL) | During first 2 months of life | As measured by presence in medical record ≤ 2 months postnatally by ultrasound (yes/no) |
| Neonatal Sepsis | During the first 4 weeks of life (neonatal period) | As measured by presence in medical record |
| Grade of Oxygen Dependency | at 6 months of age | Measured as FiO2 (oxygen) amount required as a grade (0-III) with Grade 0 indicating the best outcome and Grade III indicating the worst outcome. Grade 0 = No Bronchopulmonary Dysplasia (BPD); Grade I = FiO2 21% or room air; Grade II = FiO2 22-29%; Grade III = FiO2 \>29%, CPAP or mechanical ventilation. |
| Retinopathy of Prematurity | At the time of discharge from the NICU, an average of 1.5 months | Postnatal grade classification presence of grade III or higher using standardized system (yes/no) |
| Days to Full Enteral Feeding | At hospital discharge, an average of 1.5 months | The number of days until full enteral feeding |
| Gastroesophageal Reflux | At the time of discharge from the NICU, an average of 1.5 months | Presence of reflux above 1/3 of esophagus on clinically indicated radiologic exam |
| CDH (Congenital Diaphragmatic Hernia) Surgery Repair | From the time of birth until discharge from the NICU | How many days from birth until the surgery is performed to repair the defect. |
| Use of Patch in CDH Repair | At the time of the surgical repair postnatally, up to 3 days postnatal | The number of participants who had a patch used in the repair of the CDH defect. |
| Survival | At 24 months of age | The number of participants that survived to 24 months of age |
| Intraventricular Hemorrhage | During first month of life | Measured as presence in neonate during first month by MRI and/or ultrasound. |
| Occurrence of Severe Pulmonary Hypertension | During the first 4 weeks of life (neonatal period). | Occurrence of severe pulmonary hypertension in the neonatal period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standardized Postnatal Care (Expectant) Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.
Standardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622 | 2 |
| Prenatal Intervention (FETO) Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.
GoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.
Baltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.
Standardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622 | 3 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Standardized Postnatal Care (Expectant) | Total | Prenatal Intervention (FETO) |
|---|---|---|---|
| Age, Continuous | 32.5 years STANDARD_DEVIATION 2.1 | 32.4 years STANDARD_DEVIATION 5.5 | 32.3 years STANDARD_DEVIATION 7.6 |
| BMI | 21.5 kg/m² STANDARD_DEVIATION 0.7 | 25.2 kg/m² STANDARD_DEVIATION 3.6 | 27.6 kg/m² STANDARD_DEVIATION 1.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gestational Age at Delivery | 39.2 weeks | 39.0 weeks | 39.0 weeks |
| Liver Herniation present at Enrollment | 2 Participants | 5 Participants | 3 Participants |
| Observed to Expected Lung to Head Ratio at Enrollment | 35.5 percentage | 31 percentage | 31 percentage |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 2 | 0 / 3 |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Participants Requiring Supplemental Oxygen
The number of survivors requiring supplemental oxygen at 6 months of age
Time frame: At 6 months of age
Population: Intent to Treat Population (all participants assigned to Expectant management or FETO) of all subjects who survived to discharge from the hospital (primarly outcome #1).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | Participants Requiring Supplemental Oxygen | 1 Participants |
| Prenatal Intervention (FETO) | Participants Requiring Supplemental Oxygen | 1 Participants |
Primary
Proportion of Neonate Survival at Discharge From Hospital
The null hypothesis to be tested is that there is no difference in survival between fetuses managed expectantly during pregnancy versus those undergoing antenatal therapy (FETO).
Time frame: At hospital discharge, an average of 1.5 months
Population: Intent to Treat Population (all participants assigned to Expectant management or FETO).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | Proportion of Neonate Survival at Discharge From Hospital | 1 Participants |
| Prenatal Intervention (FETO) | Proportion of Neonate Survival at Discharge From Hospital | 3 Participants |
Secondary
CDH (Congenital Diaphragmatic Hernia) Surgery Repair
How many days from birth until the surgery is performed to repair the defect.
Time frame: From the time of birth until discharge from the NICU
Population: As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | CDH (Congenital Diaphragmatic Hernia) Surgery Repair | 1 days |
| Prenatal Intervention (FETO) | CDH (Congenital Diaphragmatic Hernia) Surgery Repair | 2.5 days |
Secondary
CDH Defect Size
Postnatal grade classification (A-D) using CDH study group standardized system with A being the smallest defects and D being the largest defects. A = Defect entirely surrounded by muscle; B = Small (\<50%) portion of the chest wall devoid of diaphragm tissue; C = Large (\>50%) portion of the chest wall devoid of diaphragm tissue; D = Complete or near complete absence of the diaphragm.
Time frame: Measured in neonate at delivery by MRI and/or ultrasound
Population: As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standardized Postnatal Care (Expectant) | CDH Defect Size | A: Entirely surrounded by muscle | 0 Participants |
| Standardized Postnatal Care (Expectant) | CDH Defect Size | B: Small (<50%) portion of the chest wall devoid of diaphragm tissue | 0 Participants |
| Standardized Postnatal Care (Expectant) | CDH Defect Size | C: Large (>50%) portion of the chest wall devoid of diaphragm tissue | 2 Participants |
| Standardized Postnatal Care (Expectant) | CDH Defect Size | D: Complete or near complete absence of the diaphragm | 0 Participants |
| Prenatal Intervention (FETO) | CDH Defect Size | D: Complete or near complete absence of the diaphragm | 0 Participants |
| Prenatal Intervention (FETO) | CDH Defect Size | A: Entirely surrounded by muscle | 0 Participants |
| Prenatal Intervention (FETO) | CDH Defect Size | C: Large (>50%) portion of the chest wall devoid of diaphragm tissue | 1 Participants |
| Prenatal Intervention (FETO) | CDH Defect Size | B: Small (<50%) portion of the chest wall devoid of diaphragm tissue | 1 Participants |
Secondary
Days to Full Enteral Feeding
The number of days until full enteral feeding
Time frame: At hospital discharge, an average of 1.5 months
Population: As-treated ('per protocol') analysis. 1 patient in the expectant management arm died and is excluded from this analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | Days to Full Enteral Feeding | 27 days |
| Prenatal Intervention (FETO) | Days to Full Enteral Feeding | 29.5 days |
Secondary
ECMO (Extracorporeal Membrane Oxygenation) Support
Need for extracorporeal membrane oxygenation (ECMO) in the neonatal period
Time frame: Neonatal period (during the first 4 weeks of life)
Population: As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | ECMO (Extracorporeal Membrane Oxygenation) Support | 1 Participants |
| Prenatal Intervention (FETO) | ECMO (Extracorporeal Membrane Oxygenation) Support | 2 Participants |
Secondary
Gastroesophageal Reflux
Presence of reflux above 1/3 of esophagus on clinically indicated radiologic exam
Time frame: At the time of discharge from the NICU, an average of 1.5 months
Population: As-treated ('per protocol') analysis. 1 patient in the expectant management arm died and is excluded from this analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | Gastroesophageal Reflux | 1 Participants |
| Prenatal Intervention (FETO) | Gastroesophageal Reflux | 0 Participants |
Secondary
Grade of Oxygen Dependency
Measured as FiO2 (oxygen) amount required as a grade (0-III) with Grade 0 indicating the best outcome and Grade III indicating the worst outcome. Grade 0 = No Bronchopulmonary Dysplasia (BPD); Grade I = FiO2 21% or room air; Grade II = FiO2 22-29%; Grade III = FiO2 \>29%, CPAP or mechanical ventilation.
Time frame: at 6 months of age
Population: As-treated ('per protocol') analysis. 1 patient in the expectant management arm died and is excluded from this analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standardized Postnatal Care (Expectant) | Grade of Oxygen Dependency | 0 = No Bronchopulmonary Dysplasia (BPD) | 0 Participants |
| Standardized Postnatal Care (Expectant) | Grade of Oxygen Dependency | I = FiO2 21% or room air | 0 Participants |
| Standardized Postnatal Care (Expectant) | Grade of Oxygen Dependency | II = FiO2 22-29% | 1 Participants |
| Standardized Postnatal Care (Expectant) | Grade of Oxygen Dependency | III = FiO2 >29%, CPAP or mechanical ventilation | 0 Participants |
| Prenatal Intervention (FETO) | Grade of Oxygen Dependency | III = FiO2 >29%, CPAP or mechanical ventilation | 0 Participants |
| Prenatal Intervention (FETO) | Grade of Oxygen Dependency | 0 = No Bronchopulmonary Dysplasia (BPD) | 1 Participants |
| Prenatal Intervention (FETO) | Grade of Oxygen Dependency | II = FiO2 22-29% | 1 Participants |
| Prenatal Intervention (FETO) | Grade of Oxygen Dependency | I = FiO2 21% or room air | 0 Participants |
Secondary
Intraventricular Hemorrhage
Measured as presence in neonate during first month by MRI and/or ultrasound.
Time frame: During first month of life
Population: As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | Intraventricular Hemorrhage | 0 Participants |
| Prenatal Intervention (FETO) | Intraventricular Hemorrhage | 0 Participants |
Secondary
Neonatal Sepsis
As measured by presence in medical record
Time frame: During the first 4 weeks of life (neonatal period)
Population: As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | Neonatal Sepsis | 1 Participants |
| Prenatal Intervention (FETO) | Neonatal Sepsis | 0 Participants |
Secondary
Number of Days in the NICU
Length of stay in the neonatal intensive care unit measured in days
Time frame: At the time of discharge from the NICU, an average of 1.5 months
Population: As-treated ('per protocol') analysis. 1 patient in the expectant management arm died and is excluded from this analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | Number of Days in the NICU | 39 days |
| Prenatal Intervention (FETO) | Number of Days in the NICU | 53 days |
Secondary
Number of Subjects With Periventricular Leukomalacia (PVL)
As measured by presence in medical record ≤ 2 months postnatally by ultrasound (yes/no)
Time frame: During first 2 months of life
Population: As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | Number of Subjects With Periventricular Leukomalacia (PVL) | 0 Participants |
| Prenatal Intervention (FETO) | Number of Subjects With Periventricular Leukomalacia (PVL) | 0 Participants |
Secondary
Occurrence of Severe Pulmonary Hypertension
Occurrence of severe pulmonary hypertension in the neonatal period.
Time frame: During the first 4 weeks of life (neonatal period).
Population: As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | Occurrence of Severe Pulmonary Hypertension | 2 Participants |
| Prenatal Intervention (FETO) | Occurrence of Severe Pulmonary Hypertension | 2 Participants |
Secondary
Retinopathy of Prematurity
Postnatal grade classification presence of grade III or higher using standardized system (yes/no)
Time frame: At the time of discharge from the NICU, an average of 1.5 months
Population: As-treated ('per protocol') analysis. 1 patient in the expectant management arm died and is excluded from this analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | Retinopathy of Prematurity | 0 Participants |
| Prenatal Intervention (FETO) | Retinopathy of Prematurity | 0 Participants |
Secondary
Survival
The number of participants that survived to 24 months of age
Time frame: At 24 months of age
Population: Intent to Treat Population (all participants assigned to Expectant management or FETO).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | Survival | 1 Participants |
| Prenatal Intervention (FETO) | Survival | 3 Participants |
Secondary
Use of Patch in CDH Repair
The number of participants who had a patch used in the repair of the CDH defect.
Time frame: At the time of the surgical repair postnatally, up to 3 days postnatal
Population: As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | Use of Patch in CDH Repair | 2 Participants |
| Prenatal Intervention (FETO) | Use of Patch in CDH Repair | 2 Participants |
Secondary
Ventilatory Support
Length of time participants required ventilator support measured in days.
Time frame: During the first 4 weeks of life (neonatal period)
Population: As-treated ('per protocol') analysis. 1 patient in the expectant management arm died and is excluded from this analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standardized Postnatal Care (Expectant) | Ventilatory Support | 18 days |
| Prenatal Intervention (FETO) | Ventilatory Support | 21 days |