RAFT Trial

The University of Texas Health Science Center at Houston (UTHealth) is one of 10 centers in the nation participating in the Renal Anhydramnios Fetal Therapy (RAFT) Trial, sponsored by Johns Hopkins University and funded by the National Institutes of Health. Mothers who enroll in the trial will be treated at the trial site, The Fetal Center at Children’s Memorial Hermann Hospital, an international leader in fetal diagnosis, fetal intervention, and comprehensive multidisciplinary care for infants with congenital anomalies or genetic abnormalities.

Early pregnancy renal anhydramnios (EPRA) is a catastrophic event were there is absence of amniotic fluid due to lack of fetal kidneys to develop (renal agenesis), renal failure due to cystic disease of the kidneys or obstruction of urinary flow (bladder outlet obstruction). The absence of amniotic fluid results in fetal deformations, including abnormal posturing of the legs, feet, and hands, and even more important, compression of the baby’s chest and inadequate lung development (pulmonary hypoplasia). Before 22 weeks, the lack of amniotic fluid is uniformily fatal. Patients who choose to continue the pregnancy will have a stillbirth or the baby will die shortly after delivery due to the pulmonary hypoplasia. Until now, treatment options have been limited to pregnancy continuation or termination.

The RAFT Trial offers eligible pregnant women with a diagnosis of EPRA an experimental therapy, serial amnioinfusions.. During the procedure, experts in fetal intervention insert a small needle into the uterus next to the baby to slowly infuse warm sterile fluid with balanced electrolytes and antibiotics. The goal is to maintain a normal amount of amniotic fluid  that will allow the baby’s lungs grow  to  survival after birth. Limited case reports have suggested that serial amnioinfusions may improve outcomes in the baby’s lung function and survival

Families considering participation in the trial will be counseled by an affiliated pediatric nephrologist, pediatric surgeon, transplant surgery specialist, clinical licensed social worker, genetic counselor, and maternal-fetal medicine specialist. Counseling will address the need for multiple amnioinfusions, the uncertainty of their success in preventing pulmonary hypoplasia, and the risk of early rupture of membranes and premature delivery. In addition, they will be made aware of the postnatal challenges the infant will face. These include the need for dialysis, the need for supplemental nutrition likely by gastrostomy tube, the risk of sepsis and thrombosis, recurrent hospitalizations, the eventual need for kidney transplant, the requirement for immunosuppression after a kidney transplant, and the likely need for urinary tract reconstruction.

Families who choose to continue in the trial will be asked to select the study arm in which they would like to participate. Those who choose Arm 1 will receive serial amnioinfusions; those who choose Arm 2, expectant observation, will not receive amnioinfusions and will be monitored by physicians at The Fetal Center for the remainder of their pregnancy, or may choose to return to their referring physician for monitoring and delivery.  Patient who elected expectant observation and return to their referring physician will be asked to return to The Fetal Center at 32 weeks of pregnancy (approximately 8 week prior to their delivery data) for additional ultrasound and MRI evaluation.   Researchers will follow babies and their families until either kidney transplant or death.

Pregnant women with a diagnosis of EPRA may enroll in the trial at The Fetal Center at UTHealth or at one of 9 other centers across the country. Due to the significant risk of early rupture of membranes and early delivery for patients who receive amnioinfusions, participants will be enrolled using very strict criteria. We also will ensure that they are well informed of these risks before they decide to participate.

To learn more about the trial, visit https://clinicaltrials.gov/ct2/show/NCT03101891.

To refer a patient, please call 832.325.7288 to speak with Anthony Johnson, DO, site principal investigator;; Robyn Torey, BSN;;  Ryan Wynn, PA; or Arielle Alfie-Kelly, PA