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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
Completed consults with Pediatric Nephrology, Neonatology, Transplant Surgery, Pediatric surgery, Maternal-Fetal Medicine Specialist, and Licensed Clinical Social Worker and a Genetic Counselor
Confirmed anhydramnios before 22 weeks GA for patients with fetal renal failure (excluding bilateral renal agenesis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of follow-up, up to 4 years after transplant
Awards & highlights

RAFT Trial Summary

This trial offers an experimental therapy to pregnant women with a diagnosis of early pregnancy renal anhydramnios, where the fetus does not have any amniotic fluid. The therapy is repeated or serial "amnioinfusions" of fluid into the womb, which is a risky procedure that may lead to early rupture of membranes and delivery. If the fetus survives, they will require intensive medical management and follow up.

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.Check my eligibility
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.See study design
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.

RAFT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have consulted with specialists in kidney, newborn care, transplant, surgery, pregnancy issues, social work, and genetics.
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My baby has been diagnosed with renal failure, not due to missing kidneys, with no amniotic fluid before 22 weeks.
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I do not plan to terminate my pregnancy.
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I am an expectant mother and I am 18 years old or older.

RAFT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of follow-up, up to 4 years after transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of follow-up, up to 4 years after transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 more

RAFT 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

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,956 Previous Clinical Trials
2,672,150 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,246 Previous Clinical Trials
14,816,700 Total Patients Enrolled
Eric B Jelin, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Isotonic fluid Clinical Trial Eligibility Overview. Trial Name: NCT03101891 — Phase 1
Multicystic Dysplastic Kidney Research Study Groups: Serial amnioinfusions with isotonic fluid, Expectant
Multicystic Dysplastic Kidney Clinical Trial 2023: Isotonic fluid Highlights & Side Effects. Trial Name: NCT03101891 — Phase 1
Isotonic fluid 2023 Treatment Timeline for Medical Study. Trial Name: NCT03101891 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age requirement for this experiment below thirty?

"This study is limited to adults aged 18-60, with 378 trials available for minors and 987 for seniors."

Answered by AI

Is the utilization of Serial amnioinfusions with isotonic fluid authorized by the FDA?

"Our experts at Power believe that serial amnioinfusions with isotonic fluid is only marginally safe, resulting in a score of 1. This treatment has had limited testing regarding its efficacy and safety properties."

Answered by AI

What are the criteria for participation in this research?

"This medical trial is recruiting 70 candidates who have been diagnosed with multicystic dysplastic kidney, and are of age between 18-60. Furthermore, expectant mothers must not opt for termination, sign the consent form prior to 26 weeks gestation age (GA), receive initial amnioinfusion before 26 weeks GA in case of fetal renal failure(except bilateral renal agenesis) , agree to be followed up at a RAFT center during pregnancy and postnatal care until discharge."

Answered by AI

How many facilities are currently hosting this research endeavor?

"At present, 10 clinical trial sites are conducting this research. These locations include Los Angeles, Stanford and Aurora in addition to 7 other cities across the nation. To reduce travelling demands associated with enrollment, it is recommended that you select a site near your location."

Answered by AI

Are any individuals currently enrolling in this clinical experimentation?

"Affirmative. Per the details presented on clinicaltrials.gov, this study is presently enrolling volunteers; it was initially posted in March of 2017 and last modified in November 2022. 70 subjects need to be recruited from 10 distinct medical centres."

Answered by AI

What is the current participant count of this experiment?

"Affirmative, clinicaltrials.gov displays that this medical trial is actively recruiting patients and has been doing so since 18th March 2017. 70 individuals are needed from 10 different facilities, the information of which was recently updated on 10th November 2022."

Answered by AI
Recent research and studies
~11 spots leftby Apr 2025