Neonatal survival after serial amnioinfusions for fetal bilateral renal agenesis: report from the raft trial
AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY(2023)
摘要
Bilateral renal agenesis (BRA) in the fetus leads to anhydramnios and lethal pulmonary hypoplasia. We report obstetric outcomes and neonatal survival/complications for pregnancies undergoing serial amnioinfusions (AIs) in the completed BRA arm of the Renal Anhydramnios Fetal Therapy (RAFT) trial (NCT03101891). RAFT is a nonrandomized prospective clinical trial conducted at 9 North American Fetal Therapy Network sites to assess the safety and efficacy of serial AIs to treat BRA. The primary outcome was postnatal survival ≥ 14 d and dialysis access placement. Inclusion required ultrasound (US) confirmed isolated BRA, normal genetic testing, and first therapeutic AI prior to 26 w gestational age (GA). AIs were done with US guidance to maintain adequate amniotic fluid volume during pregnancy. All delivered at a RAFT center. Enrollment was suspended in July 2022 after Data Safety Monitoring Board review of neonatal morbidity and survival data. Twenty maternal-fetal pairs underwent serial AIs (Figure). There were 18 (90%) livebirths, median GA 32 w [IQR 31.8, 34]. Obstetric complications included preterm prelabor rupture of membranes (60%), chorioamniotic membrane separation (30%) and bleeding (20%). 78% (95% CI, 0.57-0.99) (n=14) of neonates survived to ≥ 14 d and had placement of dialysis access (Table). Factors associated with survival to the primary endpoint included more AIs, GA at birth ≥ 32 w, and higher birthweight (BW). 5/14 infants who met the primary outcome survived to discharge on peritoneal dialysis (PD) at a median age of 25 w [IQR 12, 32]; 2 of the 5 died after discharge. 3 of the 5 infants discharged home and one who remains in the NICU sustained strokes. Serial AIs initiated before 26 w in pregnancies with BRA mitigated lethal pulmonary hypoplasia. Survival to discharge on PD and beyond was considerably lower than survival to ≥ 14 d and strongly associated with GA and BW, highlighting the additional morbidity and mortality independent of lung function for infants lacking kidneys. Recruitment for the non-BRA fetal renal failure arm of the trial continues.View Large Image Figure ViewerDownload Hi-res image Download (PPT)
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关键词
fetal bilateral renal agenesis,serial amnioinfusions,neonatal survival
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