'TOTAL' (Tracheal Occlusion To Accelerate Lung Growth) Trial | NCT02875860

Name	Class
Baylor College of Medicine	OTHER
Universitaire Ziekenhuizen KU Leuven	OTHER

Label	Type	Description	Intervention Names
Standardized postnatal care (Expectant)	Other	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.	Other: Standardized postnatal care
Prenatal Intervention (FETO)	Experimental	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.	Device: GoldBal2 detachable balloon Device: Baltaccidbpe100 Delivery Catheter Other: Standardized postnatal care

Name	Type	Description	Arm Group Labels	Other Names
GoldBal2 detachable balloon	Device	Placement of the balloon using the plug/unplug method.	Prenatal Intervention (FETO)

Measure	Description	Time Frame
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).	At hospital discharge, an average of 1.5 months
Participants Requiring Supplemental Oxygen	The number of survivors requiring supplemental oxygen at 6 months of age	At 6 months of age

Measure	Description	Time Frame
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.	at 6 months of age

Name	Affiliation	Role
Michael Belfort, MD, PhD	Baylor College of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Baylor College of Medicine/Texas Children's Hospital		Houston	Texas	77030	United States

PubMed Identifier	Type	Citation	Retractions
17587219	Background	Jani J, Nicolaides KH, Keller RL, Benachi A, Peralta CF, Favre R, Moreno O, Tibboel D, Lipitz S, Eggink A, Vaast P, Allegaert K, Harrison M, Deprest J; Antenatal-CDH-Registry Group. Observed to expected lung area to head circumference ratio in the prediction of survival in fetuses with isolated diaphragmatic hernia. Ultrasound Obstet Gynecol. 2007 Jul;30(1):67-71. doi: 10.1002/uog.4052.
18844275

Label	URL
Information for the public and healthcare providers.	View source

ID	Title	Description
FG000	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

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 24, 2017

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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).

Intent to Treat Population (all participants assigned to Expectant management or FETO).

Posted

Count of Participants

Participants

At hospital discharge, an average of 1.5 months

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG0002 OG0013

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0013

Primary

Participants Requiring Supplemental Oxygen

The number of survivors requiring supplemental oxygen at 6 months of age

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).

Posted

Count of Participants

Participants

At 6 months of age

ID	Title	Description
OG000	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
OG001	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

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.

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.

Posted

Count of Participants

Participants

at 6 months of age

ID	Title	Description
OG000	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
OG001	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

Secondary

Occurrence of Severe Pulmonary Hypertension

Occurrence of severe pulmonary hypertension in the neonatal period.

As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.

Posted

Count of Participants

Participants

During the first 4 weeks of life (neonatal period).

ID	Title	Description
OG000	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
OG001	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

Secondary

ECMO (Extracorporeal Membrane Oxygenation) Support

Need for extracorporeal membrane oxygenation (ECMO) in the neonatal period

As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.

Posted

Count of Participants

Participants

Neonatal period (during the first 4 weeks of life)

ID	Title	Description
OG000	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
OG001	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

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.

As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.

Posted

Count of Participants

Participants

Measured in neonate at delivery by MRI and/or ultrasound

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Days in the NICU

Length of stay in the neonatal intensive care unit measured in days

Posted

Median

Full Range

days

At the time of discharge from the NICU, an average of 1.5 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Ventilatory Support

Length of time participants required ventilator support measured in days.

Posted

Median

Full Range

days

During the first 4 weeks of life (neonatal period)

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With Periventricular Leukomalacia (PVL)

As measured by presence in medical record ≤ 2 months postnatally by ultrasound (yes/no)

As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.

Posted

Count of Participants

Participants

During first 2 months of life

ID	Title	Description
OG000	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
OG001	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

Secondary

Neonatal Sepsis

As measured by presence in medical record

As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.

Posted

Count of Participants

Participants

During the first 4 weeks of life (neonatal period)

ID	Title	Description
OG000	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
OG001	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

Secondary

Intraventricular Hemorrhage

Measured as presence in neonate during first month by MRI and/or ultrasound.

As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.

Posted

Count of Participants

Participants

During first month of life

ID	Title	Description
OG000	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
OG001	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

Secondary

Retinopathy of Prematurity

Postnatal grade classification presence of grade III or higher using standardized system (yes/no)

Posted

Count of Participants

Participants

At the time of discharge from the NICU, an average of 1.5 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Days to Full Enteral Feeding

The number of days until full enteral feeding

Posted

Median

Full Range

days

At hospital discharge, an average of 1.5 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Gastroesophageal Reflux

Presence of reflux above 1/3 of esophagus on clinically indicated radiologic exam

Posted

Count of Participants

Participants

At the time of discharge from the NICU, an average of 1.5 months

ID	Title	Description
OG000	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
OG001	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

Secondary

CDH (Congenital Diaphragmatic Hernia) Surgery Repair

How many days from birth until the surgery is performed to repair the defect.

As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.

Posted

Median

Full Range

days

From the time of birth until discharge from the NICU

ID	Title	Description
OG000	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
OG001	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

Secondary

Use of Patch in CDH Repair

The number of participants who had a patch used in the repair of the CDH defect.

As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis.

Posted

Count of Participants

Participants

At the time of the surgical repair postnatally, up to 3 days postnatal

ID	Title	Description
OG000	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
OG001	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

Secondary

Survival

The number of participants that survived to 24 months of age

Intent to Treat Population (all participants assigned to Expectant management or FETO).

Posted

Count of Participants

Participants

At 24 months of age

ID	Title	Description
OG000	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
OG001	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

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	1	2	0	2	0	2
EG001	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	0	3	0	3	0	3

ID	Term
D006547	Hernia
D006548	Hernia, Diaphragmatic
D020763	Pathological Conditions, Anatomical
D000013	Congenital Abnormalities
D065630	Hernias, Diaphragmatic, Congenital

ID	Term
D013568	Pathological Conditions, Signs and Symptoms
D000082122	Internal Hernia
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups