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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
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Early pregnancy renal anhydramnios or EPRA is a condition where a pregnant woman does not have any amniotic fluid around her fetus because of a problem with the fetus's kidneys. This condition is thought to be fatal once the fetus is born because of inadequate lung growth. The Renal Anhydramnios Fetal Therapy (RAFT) Trial offers eligible pregnant women with a diagnosis of EPRA an experimental therapy of repeated or serial "amnioinfusions" of fluid into the womb. An amnioinfusion involves placing a small needle through the pregnant woman's skin into the womb next to the fetus. Warm sterile fluid with balanced electrolytes and antibiotics is then slowly infused into amniotic space inside the womb. The aim is to help the fetus's lungs grow enough so he or she can survive after birth. These amnioinfusions will be carried out by an expert in fetal interventions at a RAFT center. There is a significant risk of early rupture of membranes and early delivery in subjects who receive amnioinfusions, and any potential trial participants will be counseled about these risks before they decide whether to join the trial. Any eligible patients who, after counseling, elect to terminate the pregnancy will not be eligible to participate in the trial. All eligible patients who choose to join the RAFT trial will be able to choose their assignment into one of two arms of the study: (1) to receive serial amnioinfusions (2) to not receive amnioinfusions but receive monitoring for the remainder of the pregnancy at the RAFT center. Thus, assignment of patients to study arm will not be random, but will be decided by the participant. Fetuses who do survive after birth will require intensive medical management for kidney failure including placement of a dialysis catheter and dialysis therapy with the eventual need for a kidney transplant. Treatment for lung disease secondary to abnormal lung development may also be required. The study will follow babies and their families until non-survival or transplant.

Condition or disease Intervention/treatment Phase
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

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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
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.
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:
  • Normal saline
  • Lactated ringers solution

No Intervention: Expectant
Patients will be observed serially by ultrasound, fetal echocardiogram and MRI. Standard postnatal care will occur at a RAFT center.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. Confirmed anhydramnios before 22 weeks GA for patients with FRF or confirmed diagnosis of CoBRA
  2. Consent is signed and first therapeutic amnioinfusion can and does occur before 26 weeks and 0 days GA
  3. Confirmation that the expectant mother does not wish to undergo termination of the pregnancy
  4. Age ≥ 18 years of age for expectant mothers
  5. Willingness to be followed and deliver at a RAFT center
  6. Willingness for postnatal care to be performed at a RAFT center until discharge
  7. 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:

  1. Cervix less than 2.5 cm in length
  2. No significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray
  3. Other significant congenital anomalies in the fetus
  4. Evidence of chorioamnionitis or abruptio placentae
  5. Evidence of rupture of membranes or chorioamniotic separation
  6. Evidence of preterm labor
  7. Multiple gestation
  8. Severe maternal medical condition in pregnancy.
  9. Maternal depression as assessed by a Beck Depression Inventory score equal to or greater than 17 that is refractory to treatment
  10. Technical limitations precluding amnioinfusion

Information from the National Library of Medicine

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


Contacts
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Contact: Eric B Jelin, MD 4432873384 ejelin1@jhmi.edu
Contact: Jena Miller, MD 844-JHFETAL jmill260@jhmi.edu

Locations
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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         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Eric B Jelin, MD Johns Hopkins University
Additional Information:
Publications of Results:
Other Publications:
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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

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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
Keywords provided by Johns Hopkins University:
Amnioinfusion
Fetal therapy
Bilateral Renal Agenesis
Fetal Renal Failure
Lower Urinary Tract Obstruction (LUTO)
Anhydramnios
Additional relevant MeSH terms:
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Oligohydramnios
Multicystic Dysplastic Kidney
Syndrome
Disease
Pathologic Processes
Pregnancy Complications
Congenital Abnormalities
Kidney Diseases
Urologic Diseases
Urogenital Abnormalities
Kidney Diseases, Cystic