LB04 - Neonatal survival after serial amnioinfusions for fetal bilateral renal agenesis: Report from the RAFT trial

Thursday, February 9, 2023

3:45 PM – 4:00 PM

Location: Moscone West, Level 3

Objective: 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).

Study Design: 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.

Results: 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.

Conclusion: 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.

Primary & Presenting Author(s)

Jena L. Miller, MD (she/her/hers)

Assistant Professor
Johns Hopkins Center for Fetal Therapy
Baltimore, Maryland, United States

Slides

Coauthor(s)

Ahmet A. Baschat, MBBCH, MD (he/him/his)

Director
Johns Hopkins Center for Fetal Therapy
Baltimore, Maryland, United States
Mara Rosner, MD (she/her/hers)

Assistant Professor
Johns Hopkins Center for Fetal Therapy
Baltimore, Maryland, United States
Yair J. Blumenfeld, MD

Stanford University
Stanford, California, United States
Julie S. Moldenhauer, MD

Professor, Director of Obstetrical Services
Richard D. Wood Jr. Center for Fetal Diagnosis & Treatment, Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Anthony Johnson, DO

Professor
Division of Fetal Intervention, The Fetal Center at Children's Memorial Hermann Hospital, Department of Obstetrics, Gynecology and Reproductive Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth)
Houston, Texas, United States
Mauro Schenone, MD (he/him/his)

Division Chair, Maternal Fetal Medicine
Mayo Clinic
Rochester, Minnesota, United States
Michael V. Zaretsky, MD (he/him/his)

Associate Professor, Department of OB/GYN
Colorado Fetal Care Center
Aurora, Colorado, United States
Ramen H. Chmait, MD (he/him/his)

Director, Los Angeles Fetal Surgery; Professor, Department of Obstetrics and Gynecology
University of Southern California
Los Angeles, California, United States
JG

Juan Gonzalez Velez, MD, PhD (he/him/his)

Associate Professor, Obstetrics, Gynecology & Reproductive Sciences
UCSF School of Medicine
San Francisco, California, United States
RM

Russell S. Miller, MD

Sloane Hospital for Women Associate Professor of Prenatal Pediatrics (in Obstetrics and Gynecology)
Columbia University Medical Center
New York, New York, United States
Anita Moon-Grady, MD (she/her/hers)

Director, Fetal Cardiovascular Program
University of California, San Francisco
Mill Valley, CA, United States
EB

Ellen M. Bendel-Stenzel, MD (she/her/hers)

Mayo Clinic
Rochester, Minnesota, United States
AK

Amaris Keiser, MD (she/her/hers)

Johns Hopkins Children's Center
Baltimore, Maryland, United States
RA

Radhika Avadhani, MS

Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Angie C. Jelin, MD (she/her/hers)

Associate Professor
The Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
JD

Jonathan Davis, MD

Tufts Children's Hospital
Boston, Massachusetts, United States
DW

Daniel Warren, PhD

Johns Hopkins University
Baltimore, Maryland, United States
DH

Daniel Hanley, MD

Johns Hopkins University
Baltimore, Maryland, United States
MA

Meredith Atkinson, MD (she/her/hers)

Johns Hopkins University School of Medicine
Baltimore, Maryland, United States