Clinical Trial: Neurodegeneration in Newborns After Anesthetics

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Measurement of Biomarkers of Neurodegeneration in Newborns After Exposure to Anesthetics

Brief Summary: The purpose of the study is to quantify biomarkers of neural damage in neonates exposed to varying levels of volatile anesthetic in utero.

Detailed Summary:

This study will enroll 130 pregnant patients undergoing C-section or fetal surgery with EXIT (Ex Utero Intrapartum Treatment) procedures under epidural or general anesthesia with low (0.75 MAC) or high (2.5 MAC) concentrations of desflurane. Patients will be recruited from both the Hospital of the University of Pennsylvania (100 C Section) and Children's Hospital of Philadelphia (30 EXIT procedure).

The standard of care protocol for patients undergoing anesthesia for these cases will be followed throughout the surgery. These include monitoring and management of blood pressure, heart rate and rhythm, ventilation, oxygenation, temperature, and fluid status. Management of these parameters will be at the discretion of the clinical team. The choice of the anesthetic technique will also be at the discretion of the clinical team. Typical anesthetic management includes the following:

C-section under epidural anesthesia: induction and maintenance with 1.5% lidocaine, sodium bicarbonate and 1:200,000 epinephrine

C-section under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 4.5-5%

EXIT procedure under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 15-18%

  1. After the baby is delivered, and the umbilicus is cut, two ml of blood will be taken from the umbilical vein and artery on the placenta side. A portion of the blood will be used for the blood gas and the remainder will be used for the S100B study assay.
  2. 5 ml of blood will be taken from the mother via the existing intrave
    Sponsor: University of Pennsylvania

    Current Primary Outcome: S100β Umbilical [ Time Frame: 1 day ]

    as measured by the concentration of biomarker in umbilical arterial and venous blood


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • S100β Amniotic [ Time Frame: 1 day ]
      as measured by the concentration of biomarker in maternal amniotic fluid
    • S100β Blood [ Time Frame: 1 day ]
      as measured by the concentration of biomarker in maternal blood
    • Blood gas [ Time Frame: 1 day ]
      as measured by the results of umbilical arterial and venous blood


    Original Secondary Outcome: Same as current

    Information By: University of Pennsylvania

    Dates:
    Date Received: February 22, 2017
    Date Started: November 5, 2010
    Date Completion: September 1, 2019
    Last Updated: February 22, 2017
    Last Verified: February 2017