Neurodegeneration in Newborns After Anesthetics

Measurement of Biomarkers of Neurodegeneration in Newborns After Exposure to Anesthetics

Sponsors

Lead Sponsor: University of Pennsylvania

Collaborator: Children's Hospital of Philadelphia

Source University of Pennsylvania
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 Description

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 intravenous catheter.

3. 5 ml of amniotic fluid will be obtained at hysterotomy and will be used for the S100B study assay.

All subjects will receive standard of care post operative clinical care and monitoring.

Overall Status Completed
Start Date November 5, 2010
Completion Date February 6, 2018
Primary Completion Date February 6, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
S100β Umbilical 1 day
Secondary Outcome
Measure Time Frame
S100β Amniotic 1 day
S100β Blood 1 day
Blood gas 1 day
Enrollment 25
Condition
Intervention

Intervention Type: Other

Intervention Name: Fluid collection

Description: Fluids tested for biomarker S100beta

Arm Group Label: pregnant women

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

1. Women delivering a child via cesarean section or EXIT procedure

2. Informed consent

Exclusion Criteria:

1. Known fetal neurologic defect

2. Known maternal neurologic abnormality

3. Sensitivity or allergy to medications used in the study

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

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

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Huafeng Wei, MD Principal Investigator University of Pennsylvania
Location
Facility: University of Pennsylvania
Location Countries

United States

Verification Date

February 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: pregnant women

Description: Women undergoing c-section or EXIT procedure

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov