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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
percutaneous fetoscopy, positioning of endoluminal balloon at 27-30 weeks and whenever possible elective removal at 34 weeks
pregnancy surveillance for fetal wellbeing, development of polyhydramnios and cervical shortening
University of Texas Health Science Center
Houston, Texas, United States
Mater Mother's Hospital
Brisbane, Queensland, Australia
University Hospitals Leuven
Leuven, Belgium
Survival 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.
Time frame: at discharge from neonatal intensive care unit
prenatal increase in lung volume after FETO
volume of lung after occlusion
Time frame: prior to balloon removal
grading of oxygen dependency
Time frame: born >32 wks: between 28-56d of life; born <32wks: 36wks postmenstrual age
occurrence of pulmonary hypertension
determined by cardiac ultrasound
Time frame: within first weeks of life
number of days in Neonatal Intensive Care Unit (NICU)
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.
Time frame: within hospital stay
number of days of ventilatory support
Time frame: within NICU stay
presence of periventricular leucomalacia
Time frame: 2 months of life
presence of neonatal sepsis, intraventricular haemorrhage, retinopathy grade III or higher
Time frame: within hospital stay
number of days till full enteral feeding
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Mount Sinai Hospital
Toronto, Ontario, Canada
Hôpital Antoine Béclère
Clamart, France
University Hospital of Bonn
Bonn, Germany
Ospedale Maggiore Policlinico
Milan, 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
...and 2 more locations
Time frame: within first 2 years of life
presence of gastro-esophagal reflux
Time frame: at discharge
day of surgery
Time frame: within hospital stay
requirement for use of patch for repair
Time frame: at the time of postnatal surgery
bronchopulmonary dysplasia
defined as oxygen need for at least 28 days
Time frame: with the first 8 weeks
Need for Extracorporeal membrane oxygenation
Time frame: during NICU admission
Defect size
Time frame: at the time of postnatal surgery
number of days alive in case of postnatal death
Time frame: during NICU admission