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

University Hospital, Gasthuisberg

Status and phase

Completed

Phase 3

Phase 2

Conditions

Congenital Diseases

Pulmonary Hypoplasia

Diaphragmatic Hernia

Treatments

Procedure: fetal endoluminal tracheal occlusion

Other: watchful waiting during pregnancy

Study type

Interventional

Funder types

Other

Identifiers

NCT01240057

B32220108118 (Other Identifier)

ML 6277

Details and patient eligibility

About

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.

Enrollment

93 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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