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

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.

Conditions

• Hernia
• Hernia, Diaphragmatic
• Hernia, DIaphragmatic, Congenital
• Pathological Conditions, Anatomical
• Congenital Abnormalities
• Congenital Diaphragmatic Hernia
• Fetal Anomaly
• Fetal Surgery
• Pulmonary Hypoplasia

Interventions

DEVICE

GoldBal2 detachable balloon

Placement of the balloon using the plug/unplug method.

DEVICE

Baltaccidbpe100 Delivery Catheter

The catheter assists with implanting the balloon in the plug/unplug method.

OTHER

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

Sponsors & Collaborators

• Baylor College of Medicine

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Michael A Belfort

  lead OTHER

Principal Investigators

• Michael Belfort, MD, PhD · Baylor College of Medicine - Texas Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2019-10-31

Completion

2019-10-31

FDA Device

Yes

Countries

• United States

Study Locations