The purpose of the study is to determine if babies with left or right-sided CDH that undergo the FETO procedure survive more often and have fewer long-term complications than babies that have similar left or right-sided CDH that elect not to have the FETO procedure performed during pregnancy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGCompare neonatal survival to discharge in LCDH
Time frame: 6-12 months (birth to discharge)
Compare neonatal survival to discharge in RCDH
Time frame: 6-12 months (birth to discharge)
Number of successful placements the of FETO balloon Gestational age of 27 weeks 0 days gestation to 29 weeks 6 days gestation
Time frame: 27weeks 0 days gestation to 29 weeks 6 days gestation
Number of successful retrievals/puncture of the FETO balloon Gestational age of 33 weeks 0 days to 35 weeks 0 days
Time frame: Removal prior to delivery at approximately 34 weeks of gestation
Number of FETO procedure complications
FETO procedure complications include: Failure of the FETO insertion procedure; FETO device dislodgement potentially requiring a second FETO insertion; Fetal intraoperative injury; Procedural hemorrhage: Bleeding from insertion site or Abruptions; Post-procedural hemorrhage; Preterm premature rupture of membranes; Preterm delivery; Chorioamnion separation; Chorioamnionitis; Polyhydramnios; Oligohydramnios; Emergent removal due to obstetrical complication; Failed percutaneous or fetoscopic removal requiring cesarean section or Ex-Utero Intrapartum Therapy(EXIT) procedure for removal; Neonatal death due to asphyxia if delivery before FETO removal; Non-reassuring fetal heart rate monitoring.
Time frame: Balloon placement to delivery (27 weeks up to delivery approximately 40 weeks)
Fetal lung growth difference on MRI via o/e Total Fetal Lung Volume (TFLV) (FETO Intervention Arm)
Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval. Fetal lung growth (difference between 1st and 2nd MRIs will be calculated for FETO intervention arm only).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline (prior to balloon placement) and approximately 2 weeks after balloon retrieval
Fetal lung growth difference based on prenatal ultrasound via o/e LHR (Both Arms)
Prenatal ultrasound (US) will measure the o/e LHR at weekly visits while the balloon is in place (FETO intervention arm) or at routine visits per standard of care (SOC) (expectant arm). Fetal lung growth will be calculated as the difference between the o/e LHR pre- balloon placement (or 29 + 1 week in control) and the o/e LHR immediately prior to balloon removal/puncture (or 34 + 1 week in control).
Time frame: Baseline (prior to balloon placement) and immediately prior to balloon removal and SOC arm 29 + 1 week and 34 +1 week
Long-term outcome measure infant survival rate
Time frame: After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age
Presence of pulmonary hypertension
Determination of the ratio of the tricuspid regurgitation jet (estimation of the right ventricular systolic pressure) to systemic blood pressure where the is an objective measurement used to estimate the pulmonary artery pressure. Will be recorded as absent/none, systemic or suprasystemic.
Time frame: After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age
Presence of need for supplemental oxygen
Time frame: After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age
Periventricular leukomalacia at <2 months postnatally
Time frame: After birth at 2 months
Infant sepsis
Time frame: After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age
Intraventricular hemorrhage (grade 0-III)
Time frame: After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age
Retinopathy of prematurity (grade 3 or higher)
Time frame: After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age
Gastroesophageal reflux
Time frame: After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age
Number and cause of infant hospital readmissions
Time frame: After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age
Long-term outcome measure childhood growth failure
Childhood growth failure: weight gain velocity or decline \>2 in weight, for length Z score.
Time frame: After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age
Recurrence of CDH repair
Time frame: After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age
Bowel obstruction
Time frame: After birth at 6, 12, 18, and 24 months (+ 2 months) of corrected age
Neurodevelopmental delay
Bayley Scales of Infant and Toddler Development- III(BSID)\>2 Standard deviation (SD) below mean, or other categorization at 24 months
Time frame: 24 months (+ 2 months) of corrected age
Bronchopulmonary dysplasia
Time frame: After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age