Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia

Phase 2

Completed

• Conditions: Congenital Diseases; Diaphragmatic Hernia; Pulmonary Hypoplasia
• Interventions: Procedure: fetal endoluminal tracheal occlusion; Other: watchful waiting during pregnancy

• Registration Number: NCT01240057
• Lead Sponsor: University Hospital, Gasthuisberg

Brief Summary

This trial investigates whether prenatal intervention improves survival rate of fetuses with isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to expectant management during pregnancy, both followed by standardized postnatal care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Study Start: 2011-11
• Primary Completion: 2020-03
• Study Completion: 2020-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

Inclusion Criteria

• Patients aged 18 years or more, who are able to consent
• Singleton pregnancy
• Anatomically and chromosomally normal fetus
• Left sided diaphragmatic hernia
• Gestation at randomization prior to 29 wks plus 5 d (so that occlusion is done at the latest on 29 wks plus 6 d)
• Estimated to have severe pulmonary hypoplasia, defined prenatally as: O/E LHR <25 %, irrespective of the liver position
• Acceptance of randomization and the consequences for the further management during pregnancy and thereafter.
• 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".
• Provide written consent to participate in this RCT

Exclusion Criteria

• Maternal contraindication to fetoscopic surgery or severe medical condition in pregnancy that make fetal intervention risk full
• Technical limitations precluding fetoscopic surgery, such as severe maternal obesity, uterine fibroids or potentially others, not anticipated at the time of writing this protocol.
• Preterm labour, cervix shortened (<15 mm at randomization) or uterine anomaly strongly predisposing to preterm labour, placenta previa
• Patient age less than 18 years
• Psychosocial ineligibility, precluding consent
• Diaphragmatic hernia: right-sided or bilateral, major anomalies, isolated left-sided outside the O/E LHR limits for the inclusion criteria
• Patient refusing randomization or to comply with return to FETO center during the time period the airways are occluded or for elective removal of the balloon

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fetal endoluminal tracheal occlusion	fetal endoluminal tracheal occlusion	fetoscopic balloon occlusion at 27 to 29+6 weeks of gestation
expectant management during pregnancy	watchful waiting during pregnancy	watchful waiting during pregnancy

Primary Outcome Measures

Name	Time	Method
Survival at discharge from neonatal intensive care unit	at discharge from neonatal intensive care unit	The baby can be discharged either alive (and then it qualifies as "surviving at discharge") or dead. Not discharged babies have not reached the primary endpoint.

Secondary Outcome Measures

Name	Time	Method
presence of neonatal sepsis, intraventricular haemorrhage, retinopathy grade III or higher	within hospital stay
presence of periventricular leucomalacia	2 months of life
occurrence of pulmonary hypertension	within first weeks of life	determined by cardiac ultrasound
number of days till full enteral feeding	within first 2 years of life
presence of gastro-esophagal reflux	at discharge
prenatal increase in lung volume after FETO	prior to balloon removal	volume of lung after occlusion
grading of oxygen dependency	born >32 wks: between 28-56d of life; born <32wks: 36wks postmenstrual age
number of days in Neonatal Intensive Care Unit (NICU)	within hospital stay	As long as the baby is in the hospital, it is hospitalized either in NICU or in another, less intensive care unit.; The number of days in NICU is an outcome variable, expressed in days.
number of days of ventilatory support	within NICU stay
requirement for use of patch for repair	at the time of postnatal surgery
Need for Extracorporeal membrane oxygenation	during NICU admission
Defect size	at the time of postnatal surgery
number of days alive in case of postnatal death	during NICU admission
day of surgery	within hospital stay
bronchopulmonary dysplasia	with the first 8 weeks	defined as oxygen need for at least 28 days

Trial Locations

Locations (12)

University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States

Mater Mother's Hospital; 🇦🇺 Brisbane, Queensland, Australia

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

Hôpital Antoine Béclère; 🇫🇷 Clamart, France

University Hospital of Bonn; 🇩🇪 Bonn, Germany

Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy

Ospedale Pediatrico Bambino Gesù; 🇮🇹 Rome, Italy

National Center for Child Health and Development; 🇯🇵 Tokyo, Japan

1st Department of Obstetrics and Gynecology, Medical University of Warsaw; 🇵🇱 Warsaw, Poland

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