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Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05704257
Recruitment Status : Recruiting
First Posted : January 30, 2023
Last Update Posted : June 1, 2023
Sponsor:
Information provided by (Responsible Party):
Sundeep Keswani, Baylor College of Medicine

Study Description
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Brief Summary:
The goal of this clinical trial is to evaluate the safety and feasibility of fetal repair of complex gastroschisis (GS) via a fetoscopic surgical approach by assessing maternal, fetal, neonatal, and infant outcomes in a cohort of 10 patients. The hypothesis is that in utero repair of GS will reduce postnatal mortality and morbidity in complex GS infants with minimal maternal and fetal risk.

Condition or disease Intervention/treatment Phase
Gastroschisis Device: fetoscopy Not Applicable

Detailed Description:

Gastroschisis is a congenital abdominal wall defect by which the intestinal structures eviscerate from the abdomen, with a current prevalence of 4.9 per 10,000 pregnancies in the United States. Not only is it the most common abdominal wall defect, but the incidence of GS has increased by nearly 30% in the US (Jones et al., 2016) and 25 % in Europe (EUROCAT, 2021) between 2006 and 2012 for reasons that are still unknown. Two subtypes of the disease have been identified - simple and complex GS. Simple GS presents as an otherwise healthy bowel that may have an inflammatory peel over the bowel surface. By contrast, complex GS is characterized by serious bowel complications, such as bowel volvulus, atresia, stenosis, necrosis, and perforation.

Participants will be offered the minimally invasive in-utero repair technique as an alternative to the traditional standard postnatal GS surgical repair. During surgery, the mother's uterus is opened using the standard laparotomy approach that we currently use in our open fetal surgeries and fetoscopic spina bifida repair through an exteriorized uterus, and then fetal surgeons repair the fetus' defect. The uterus is closed, and the pregnancy continues. When babies are treated in this way, they may be less likely to be born with their intestines coming out of their belly and if this is the case, they may be less likely to have other problems that occur with gastroschisis because the intestines are not covered.

All participants will be closely followed with ultrasound and consultation after the surgery. Delivery will be scheduled at Texas Children's Hospital, and the infants will be followed for 12 months by our research team.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Estimated Study Start Date : August 2023
Estimated Primary Completion Date : December 2029
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: fetoscopic surgical repair
Single arm study. All patients will receive the fetoscopic repair.
 Device: fetoscopy
The fetoscopic arm is described above. All patients will have a laparotomy, exteriorization of the uterus, and a fetoscopic repair of the gastroschisis.


Outcome Measures
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Primary Outcome Measures :
  1. Successful Repair of Complex Gastroschisis [ Time Frame: At end of surgical repair ]
    Success of primary skin closure after complete bowel reduction.


Secondary Outcome Measures :
  1. Intrauterine Fetal Death (IUFD) [ Time Frame: At delivery ]
    Demise of fetus while still in the womb

  2. Preterm Birth [ Time Frame: At delivery ]
    Number of patients that deliver at < 37 weeks gestation

  3. Time to initiation of enteral feeds (days) [ Time Frame: At hospital discharge, an average of 1.5 months ]
    The number of days until initiation of enteral feeding

  4. Time on total parenteral nutrition (TPN) (days) [ Time Frame: At hospital discharge, an average of 1.5 months ]
    The number of days on total parenteral nutrition (TPN)

  5. Necrotizing Enterocolitis [ Time Frame: At hospital discharge, an average of 1.5 months ]
    As measured by presence in medical record

  6. Short Bowel Syndrome [ Time Frame: At hospital discharge, an average of 1.5 months ]
    As measured by presence in medical record

  7. Length of Hospital Stay [ Time Frame: At the time of discharge from the NICU, an average of 1.5 months ]
    Length of stay in the hospital measured in days

  8. Intracranial hemorrhage [ Time Frame: During first month of life ]
    Measured as presence in neonate during first month by MRI and/or ultrasound.

  9. Retinopathy of Prematurity [ Time Frame: At the time of discharge from the NICU, an average of 1.5 months ]
    Postnatal grade classification presence of grade III or higher using standardized system (yes/no)

  10. Respiratory Distress Syndrome [ Time Frame: At the time of discharge from the NICU, an average of 1.5 months ]
    As measured by presence in medical record

  11. Bronchopulmonary Dysplasia [ Time Frame: At the time of discharge from the NICU, an average of 1.5 months ]
    As measured by presence in medical record

  12. Need for Gastroschisis related surgery [ Time Frame: 12 months of age ]
    As measured by presence in medical record ≤12 months

  13. Small Bowel Obstruction [ Time Frame: 12 months of age ]
    As measured by presence in medical record ≤12 months

  14. Central Line Associated Bloodstream Infection (CLABSI) [ Time Frame: 12 months of age ]
    As measured by presence in medical record ≤12 months

  15. Neuro-developmental Outcome at 12 months [ Time Frame: 12 months of age ]
    As measured by the Capute Scales at 12 months

  16. Survival at 12 months [ Time Frame: 12 months of age ]
    Number of patients alive at 12 months of age


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pregnant women - maternal age 18 years or older and capable of consenting for her own participation in this study
  2. Singleton pregnancy
  3. Sonographic evidence of gastroschisis (exteriorization of bowel content outside the fetal abdominal cavity into the amniotic cavity)
  4. Intraabdominal bowel dilation ≥ 10 mm at 20-24 weeks GA reviewed by prenatal ultrasound
  5. Absence of significant associated anomalies* diagnosed on prenatal ultrasound or MRI
  6. Gestational age at the time of the procedure will be between 20 0/7 weeks and 25 6/7 weeks
  7. Absence of chromosomal and clinically significant abnormalities, i.e., normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included. Patients declining invasive testing will be excluded
  8. The family has considered and declined the option of termination of the pregnancy at less than 24 weeks and of standard postnatal treatment
  9. The family meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study)

  10. Parental/guardian permission (informed consent) for follow up of the child after birth

    • Significant associated anomalies are defined as such anomalies that would, in and of themselves, be life limiting or life threatening. A minor anomaly, such as a small VSD or ASD not deemed to be life limiting or threatening, or a cleft lip or other such anomaly, unless part of a genetic syndrome, will not disqualify the patient.

Exclusion Criteria:

  1. Significant fetal anomaly unrelated to gastroschisis
  2. Evidence of bowel perforation (presence of intraabdominal bowel calcification on ultrasonography)
  3. Increased risk for preterm labor including short cervical length (≤ 2.0 cm), history of incompetent cervix with or without cerclage, and previous preterm birth in a singleton pregnancy (other than a patient delivered for a non-repeating medical or surgical indication)
  4. Placental abnormalities (previa, abruption, accreta) known at time of enrollment
  5. Pre-pregnancy body-mass index (BMI) ≥40
  6. Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment
  7. Technical limitations precluding fetoscopic surgery, such as extensive uterine fibroids, fetal membrane separation, or uterine anomalies
  8. Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
  9. Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
  10. Maternal medical condition that is a contraindication to surgery or general anesthesia
  11. Low amniotic fluid volume (Amniotic Fluid Index less than 6 cm) if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture. Low amniotic fluid volume that responds to maternal hydration is not an exclusion criterion
  12. Patient does not have a support person (i.e., spouse, partner, or mother) available to support her for the duration of the pregnancy
  13. Inability to comply with the travel and follow-up requirements of the trial
  14. Patient scores as severely depressed on the Edinburgh Postnatal Depression Scale (EPDS)
  15. Patients that are enrolled or have been enrolled in any another intervention study that affects the mother or fetus
  16. Maternal hypersensitivity to any of the entities associated w/ AlloDerm™. The use of AlloDerm™ Regenerative Tissue Matrix distributed by Allergan Aesthetics is contraindicated for patients sensitive to any of the antibiotics listed on the AlloDerm package, i.e., Gentamycin, Cefoxitin, Lincomycin, Polymyxin B and Vancomycin or Polysorbate 20
Contacts and Locations
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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): NCT05704257


Contacts
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Contact: Sundeep Keswani, MD 832-824-0462 sgkeswan@texaschildrens.org
Contact: Becky Johnson 832-826-7451 rj2@bcm.edu

Locations
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United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Sundeep Keswani, MD         
Contact: Becky Johnson    832-826-7451    rj2@bcm.edu   
Sub-Investigator: Michael A Belfort, MD, PhD         
Sub-Investigator: Luc Joyeux, MD, PhD         
Sub-Investigator: Larry Hollier Jr., MD         
Sub-Investigator: Timothy Lee, MD         
Sub-Investigator: Alice King, MD         
Sub-Investigator: Magdalena Sanz Cortes, MD, PhD         
Sub-Investigator: Ahmed Nassr, MD, PhD         
Sub-Investigator: Roopali Donepudi, MD         
Sub-Investigator: Jonathan Castillo Porter, MD, MPH         
Sub-Investigator: Caitlin Sutton, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Sundeep Keswani, MD Baylor College of Medicine and Texas Children's Hospital
More Information
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Responsible Party: Sundeep Keswani, Chief of Pediatric Surgery, Professor, Departments of Surgery, Pediatrics & OB/Gyn, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05704257    
Other Study ID Numbers: H-51929
First Posted: January 30, 2023    Key Record Dates
Last Update Posted: June 1, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Sundeep Keswani, Baylor College of Medicine:
Gastroschisis
Abdominal Wall Defect
Additional relevant MeSH terms:
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Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
 Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical