Renal Anhydramnios Fetal Therapy (RAFT)
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ClinicalTrials.gov Identifier: NCT03101891 |
Recruitment Status :
Recruiting
First Posted : April 5, 2017
Last Update Posted : February 21, 2021
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Condition or disease | Intervention/treatment | Phase |
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Bilateral Renal Agenesis Oligohydramnios Anhydramnios Potter Syndrome Lung Hypoplasia Multicystic Dysplastic Kidney Multicystic Renal Dysplasia, Bilateral Lower Urinary Tract Obstructive Syndrome Fetal Renal Anomaly | Procedure: Serial amnioinfusions with isotonic fluid Device: Spinal needle Drug: Isotonic fluid | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 140 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | All eligible patients will be offered participation in the study. Participants can elect for invasive therapy with amnioinfusions or expectant management. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Renal Anhydramnios Fetal Therapy (RAFT) Trial |
Actual Study Start Date : | March 18, 2017 |
Estimated Primary Completion Date : | March 18, 2025 |
Estimated Study Completion Date : | March 18, 2030 |

Arm | Intervention/treatment |
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Experimental: Serial amnioinfusions with isotonic fluid
Patients will undergo amnioinfusions with isotonic fluid every 2-12 days.. A spinal needle will be used to perform the infusion. The latest infusions will begin is 26 weeks gestation. Standard postnatal care will occur at a RAFT center.
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Procedure: Serial amnioinfusions with isotonic fluid
Amnioinfusions will be performed by an expert in fetal procedures with a 20 or 22 gauge needle using sterile technique and ultrasound guidance. Local anesthetic will be employed. The fluid will consist of warmed isotonic fluid. Infusions may take up to 1 hour.
Other Name: Renal Anhydramnios Fetal Therapy (RAFT) Device: Spinal needle A 20 or 22 gauge spinal needle will be used with sterile technique to access the uterus under ultrasound guidance and to infuse isotonic fluid.
Other Name: Obstetrics and gynecology needle Drug: Isotonic fluid Isotonic fluids, including normal saline or lactated ringers solution, will be infused into the uterus through a spinal needle under ultrasound guidance using sterile technique. This fluid will act as replacement amniotic fluid.
Other Names:
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No Intervention: Expectant
Patients will be observed serially by ultrasound, fetal echocardiogram and MRI. Standard postnatal care will occur at a RAFT center.
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- Proportion of neonates surviving to successful dialysis after serial amnioinfusions (defined as use of a dialysis catheter for >=14 continuous days) [ Time Frame: Birth to either successful dialysis or nonsurvival, up to 3 weeks ]The proportion of neonates who survive to successful dialysis as well as the exact confidence interval will be presented for CoBRA and FRF patients separately in the intervention group.
- Number of infusions before rupture of membrane among those in the intervention arm [ Time Frame: During the EPRA pregnancy, up to 9 months ]The feasibility of serial amnioinfusions for EPRA will be measured the number of infusions prior to rupture of membrane among those in the intervention arm
- Mean gestational age at the time of rupture of membrane among those in the intervention arm [ Time Frame: During the EPRA pregnancy, up to 9 months ]The feasibility of serial amnioinfusions for EPRA will be measured using the mean gestational age at rupture among those in the intervention arm
- Mean gestational age at delivery among those in the intervention arm [ Time Frame: During the EPRA pregnancy, up to 9 months ]The feasibility of serial amnioinfusions for EPRA will be measured using the mean gestational age at delivery among those in the intervention arm
- Rate of in utero fetal demise among those in the non-intervention arm [ Time Frame: During the EPRA pregnancy, up to 9 months ]We will perform an exploratory study of the in utero natural history of untreated EPRA by examining the rate of in utero fetal demise among those in the non-intervention arm.
- Mean gestational age at delivery among those in the non-intervention arm [ Time Frame: During the EPRA pregnancy, up to 9 months ]We will perform an exploratory study of the in utero natural history of untreated EPRA by examining the mean gestational age among those in the non-intervention arm
- Correlations between fetal ultrasound, echocardiogram MRI biomarkers as well as amniotic fluid biomarkers, and the success of RAFT for EPRA [ Time Frame: End of follow-up, up to 4 years after transplant ]The correlations between fetal ultrasound, echocardiogram MRI biomarkers as well as amniotic fluid biomarkers and the success of RAFT for EPRA will be assessed.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Pregnant women are the focus of this study |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed anhydramnios before 22 weeks GA for patients with FRF or confirmed diagnosis of CoBRA
- Consent is signed and first therapeutic amnioinfusion can and does occur before 26 weeks and 0 days GA
- Confirmation that the expectant mother does not wish to undergo termination of the pregnancy
- Age ≥ 18 years of age for expectant mothers
- Willingness to be followed and deliver at a RAFT center
- Willingness for postnatal care to be performed at a RAFT center until discharge
- Completed consults with Pediatric Nephrology, Neonatology, Transplant Surgery, Pediatric surgery, Maternal-Fetal Medicine Specialist, and Licensed Clinical Social Worker and a Genetic Counselor
Exclusion Criteria:
- Cervix less than 2.5 cm in length
- No significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray
- Other significant congenital anomalies in the fetus
- Evidence of chorioamnionitis or abruptio placentae
- Evidence of rupture of membranes or chorioamniotic separation
- Evidence of preterm labor
- Multiple gestation
- Severe maternal medical condition in pregnancy.
- Maternal depression as assessed by a Beck Depression Inventory score equal to or greater than 17 that is refractory to treatment
- Technical limitations precluding amnioinfusion

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101891
Contact: Eric B Jelin, MD | 4432873384 | ejelin1@jhmi.edu | |
Contact: Jena Miller, MD | 844-JHFETAL | jmill260@jhmi.edu |
United States, California | |
University of Southern California | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Arlyn Llanes 626-356-3360 arlyn.llanes@med.usc.edu | |
Contact: Arlyn Llanes 661-714-6246 | |
Principal Investigator: Ramen Chmait | |
Stanford University | Recruiting |
Palo Alto, California, United States, 94304 | |
Contact: Yair Blumenfeld, MD 650-724-2221 yairb@stanford.edu | |
Contact: Stephanie Neves, RN 650-724-2221 sneves@stanforchildrens.org | |
University of California San Francisco | Recruiting |
San Francisco, California, United States, 94158 | |
Contact: Kristen Gosnell 415-830-7217 Kristen.Gosnell@ucsf.edu | |
Contact: Kristen Gosnell 417-476-0445 | |
Principal Investigator: Juan Gonzalez | |
Stanford University | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Elizabeth Sherwin 650-725-5720 esherwin@stanford.edu | |
Contact: Elizabeth Sherwin 650-815-5837 | |
Principal Investigator: Yair Blumenfeld | |
United States, Colorado | |
University of Colorado Denver | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Hilary Hoffman 720-777-9904 hilary.hoffman@childrenscolorado.org | |
Contact: Hilary Hoffman 408-489-2284 | |
Principal Investigator: Michael Zaretsky | |
United States, Maryland | |
Johns Hopkins Hospital | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Jena B Miller, MD 844-543-3825 jmill260@jhmi.edu | |
Principal Investigator: Eric Jelin | |
United States, New York | |
Columbia University | Recruiting |
New York, New York, United States, 10032 | |
Contact: Vilmarie Carmona 212-305-5041 vc2007@cumc.columbia.edu | |
Contact: Vilmarie Carmona 646-285-2896 | |
Principal Investigator: Russell Miller | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Susan Spinner 215-590-5190 spinners@email.chop.edu | |
Contact: Susan Spinner 267-239-3108 | |
Principal Investigator: Julie Moldenhauer | |
United States, Texas | |
University of Texas Health Science Center at Houston | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Sunbola S Ashimi 713-500-6410 sunbola.s.ashimi@uth.tmc.edu | |
Principal Investigator: Anthony Johnson |
Principal Investigator: | Eric B Jelin, MD | Johns Hopkins University |
Publications of Results:
Other Publications:
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT03101891 |
Other Study ID Numbers: |
IRB00164021 |
First Posted: | April 5, 2017 Key Record Dates |
Last Update Posted: | February 21, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Amnioinfusion Fetal therapy Bilateral Renal Agenesis |
Fetal Renal Failure Lower Urinary Tract Obstruction (LUTO) Anhydramnios |
Oligohydramnios Multicystic Dysplastic Kidney Syndrome Disease Pathologic Processes Pregnancy Complications |
Congenital Abnormalities Kidney Diseases Urologic Diseases Urogenital Abnormalities Kidney Diseases, Cystic |