Renal Anhydramnios Fetal Therapy (RAFT)
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|ClinicalTrials.gov Identifier: NCT03101891|
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : January 13, 2020
|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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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)|
|Official Title:||Renal Anhydramnios Fetal Therapy (RAFT) Trial|
|Actual Study Start Date :||March 18, 2017|
|Estimated Primary Completion Date :||March 18, 2020|
|Estimated Study Completion Date :||March 18, 2026|
Experimental: Serial amnioinfusions with isotonic fluid
Patients will undergo amnioinfusions with isotonic fluid every 1-2 weeks. 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.
No Intervention: Expectant
Patients will be observed serially by ultrasound, fetal echocardiogram and MRI. Standard postnatal care will occur at a RAFT center.
- Survival to successful dialysis [ Time Frame: Birth to either successful dialysis or nonsurvival. ]To evaluate the efficacy of serial saline amnioinfusions to prevent lethal pulmonary hypoplasia in patients with EPRA. Survival or nonsurvival to the endpoint of successful dialysis defined as 15 continuous days of dialysis catheter usage will be measured.
- Maternal safety: the rate of maternal adverse events [ Time Frame: These outcomes will be measured at every prenatal visit, after every prenatal procedure, at delivery and 30 days after delivery. ]To evaluate the safety of serial amnioinfusions in patients with EPRA. Safety of the infusions will be determined by the rate of maternal adverse events (if any) with infusion. superficial wound infection requiring antibiotics, bleed requiring transfusion, and death.
- Number of serial amnioinfusions before preterm premature rupture of membranes or preterm delivery. [ Time Frame: Pregnancy ]To evaluate the feasibility of serial amnioinfusions without rupture of membranes or preterm birth for EPRA pregnancies.
- Survival to transplant [ Time Frame: Birth to either successful renal transplant (usually around 2 years of life) or nonsurvival ]To determine the proportion of patients treated with RAFT who successfully receive renal transplant.
- Quality of life using Pediatric Quality of Life Inventory 4.0 (PedsQL TM) survey [ Time Frame: 1 and 2 years of life and then 1, 2 3 and 4 years after transplant ]To determine the quality of life of patients that undergo RAFT. The parent proxy score will be used until the child is 5 years of age.
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, MDemail@example.com|
|Contact: Jena Miller, MD||844-JHFETALfirstname.lastname@example.org|
|United States, California|
|Palo Alto, California, United States, 94304|
|Contact: Yair Blumenfeld, MD 650-724-2221 email@example.com|
|Contact: Stephanie Neves, RN 650-724-2221 firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Eric B Jelin, MD|
|Principal Investigator:||Eric B Jelin, MD||Johns Hopkins University|