Abstract
Purpose
Anhydramnios secondary to anuria before 22 weeks of gestational age and congenital
bilateral renal agenesis before 26 weeks of gestational age are collectively referred
to as early-pregnancy renal anhydramnios. Early-pregnancy renal anhydramnios occurs
in at least 1 in 2000 pregnancies and is considered universally fatal when left untreated
because of severe pulmonary hypoplasia precluding ex utero survival The Renal Anhydramnios
Fetal Therapy (RAFT) trial is a nonrandomized, nonblinded, multicenter clinical trial
designed to assess the efficacy, safety, and feasibility of amnioinfusions for patients
with pregnancies complicated by early-pregnancy renal anhydramnios. The primary objective
of this study is to determine the proportion of neonates surviving to successful dialysis,
defined as use of a dialysis catheter for ≥14 days.
Methods
A consortium of 9 North American Fetal Therapy Network (NAFTNet) centers was formed,
and the RAFT protocol was refined in collaboration with the NAFTNet Scientific Committee.
Enrollment in the trial began in April 2020. Participants may elect to receive amnioinfusions
or to join the nonintervention observational expectant management group. Eligible
pregnant women must be at least 18 years of age with a fetal diagnosis of isolated
early-pregnancy renal anhydramnios.
Findings
In addition to the primary study objective stated above, secondary objectives include
(1) to assess maternal safety and feasibility of the serial amnioinfusion intervention
(2) to perform an exploratory study of the natural history of untreated early pregnancy
renal anhydramnios (3) to examine correlations between prenatal imaging and lung specific
factors in amniotic fluid as predictive of the efficacy of serial percutaneous amnioinfusions
and (4) to determine short- and long-term outcomes and quality of life in surviving
neonates and families enrolled in RAFT
Implications
The RAFT trial is the first clinical trial to investigate the efficacy, safety, and
feasibility of amnioinfusions to treat the survival-limiting pulmonary hypoplasia
associated with anhydramnios. Although the intervention offers an opportunity to treat
a condition known to be almost universally fatal in affected neonates, the potential
burdens associated with end-stage kidney disease from birth must be acknowledged.
ClinicalTrials.gov identifier: NCT03101891.
Keywords
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Article info
Publication history
Published online: July 30, 2022
Accepted:
July 5,
2022
Identification
Copyright
© 2022 Elsevier Inc.
