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Serial Amnioinfusions for Low Amniotic Fluid (RAFT Trial)
Phase 1
Recruiting
Led By Eric B Jelin, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed anhydramnios before 22 weeks GA for patients with fetal renal failure (excluding bilateral renal agenesis)
Confirmation that the expectant mother does not wish to undergo termination of the pregnancy
Must not have
Maternal depression as assessed by a Beck Depression Inventory score equal to or greater than 17 that is refractory to treatment
No significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of follow-up, up to 4 years after transplant
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a method of injecting fluid into the womb of pregnant women whose fetuses have a severe kidney condition that prevents normal lung development. The goal is to help the fetus's lungs grow so they can survive after birth. The trial focuses on the safety and effectiveness of this treatment for fetuses with urinary tract issues.
Who is the study for?
This trial is for pregnant women over 18 with a fetus diagnosed with EPRA, excluding bilateral renal agenesis. They must be before 22 weeks gestation, not planning to terminate the pregnancy, and able to start treatment before 26 weeks. Participants need to deliver at a RAFT center and agree to postnatal care there.
What is being tested?
The RAFT Trial tests serial amnioinfusions of isotonic fluid into the womb against standard monitoring without infusions. The goal is for the infused fluid to help fetal lung growth in cases where kidney issues have led to low amniotic fluid levels.
What are the potential side effects?
Potential side effects include early rupture of membranes and premature delivery. Babies who survive may require intensive medical management for kidney failure (dialysis, transplant) and treatment for lung disease due to abnormal development.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby has been diagnosed with renal failure, not due to missing kidneys, with no amniotic fluid before 22 weeks.
Select...
I do not plan to terminate my pregnancy.
Select...
I am an expectant mother and I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have depression that hasn't improved with treatment, confirmed by a test score.
Select...
My genetic tests show no significant abnormal findings.
Select...
My cervix is shorter than 2.5 cm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of follow-up, up to 4 years after transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of follow-up, up to 4 years after transplant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of neonates surviving to >= 14 days and placement of dialysis access after serial amnioinfusions (defined as use of a dialysis catheter for >=14 continuous days)
Secondary study objectives
Correlations between fetal ultrasound, echocardiogram MRI biomarkers as well as amniotic fluid biomarkers, and the success of RAFT for EPRA
Mean gestational age at delivery among those in the intervention arm
Mean gestational age at delivery among those in the non-intervention arm
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Serial amnioinfusions with isotonic fluidExperimental Treatment3 Interventions
There are two interventional arms to the trial. Recruitment in the bilateral renal agenesis arm of the trial was stopped in July 2022 after DSMB review.
Recruitment is ongoing in the non-bilateral renal agenesis, fetal renal failure with anhydramnios arm of the trial. 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.
Group II: ExpectantActive Control1 Intervention
Patients will be observed serially by ultrasound, fetal echocardiogram and MRI. Standard postnatal care will occur at a RAFT center.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal needle
2022
N/A
~160
Isotonic fluid
2006
Completed Phase 3
~170
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatment for Multicystic Dysplastic Kidney (MCDK) involving the physical addition of fluid to the amniotic space, such as serial amnioinfusions, works by maintaining adequate amniotic fluid levels. This is crucial for promoting fetal lung development and preventing pulmonary hypoplasia, a severe complication due to oligohydramnios.
By ensuring proper lung development, this treatment significantly improves the chances of survival and better health outcomes for MCDK patients post-birth.
Experimental congenital obstructive uropathy.Differential Diagnosis and Prognosis of Fetuses with Bilateral Enlarged, Hyperechogenic Kidneys: Renal Volume and Amniotic Fluid Volume with Advancing Gestation.Development of fetal and neonatal renal function.
Experimental congenital obstructive uropathy.Differential Diagnosis and Prognosis of Fetuses with Bilateral Enlarged, Hyperechogenic Kidneys: Renal Volume and Amniotic Fluid Volume with Advancing Gestation.Development of fetal and neonatal renal function.
Find a Location
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,803 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,725 Total Patients Enrolled
Eric B Jelin, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have consulted with specialists in kidney, newborn care, transplant, surgery, pregnancy issues, social work, and genetics.My baby has been diagnosed with renal failure, not due to missing kidneys, with no amniotic fluid before 22 weeks.I do not plan to terminate my pregnancy.I have depression that hasn't improved with treatment, confirmed by a test score.You have signs of chorioamnionitis or abruptio placentae.There are signs that the bag of waters around the baby has broken or separated from the uterus.The pregnant woman has a serious health problem.You are unable to have amnioinfusion due to technical reasons.There are signs that the baby may be born too early.My genetic tests show no significant abnormal findings.My cervix is shorter than 2.5 cm.The baby has other major birth defects.I am an expectant mother and I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Serial amnioinfusions with isotonic fluid
- Group 2: Expectant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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