Neurodegeneration in Newborns After Anesthetics

February 15, 2019 updated by: University of Pennsylvania

Measurement of Biomarkers of Neurodegeneration in Newborns After Exposure to Anesthetics

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

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant women

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pregnant women
Women undergoing c-section or EXIT procedure
Fluids tested for biomarker S100beta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
S100β Umbilical
Time Frame: 1 day
as measured by the concentration of biomarker in umbilical arterial and venous blood
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Huafeng Wei, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2010

Primary Completion (Actual)

February 6, 2018

Study Completion (Actual)

February 6, 2018

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 22, 2017

First Posted (Actual)

February 27, 2017

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 15, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 812651

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on General Anesthesia

Clinical Trials on Fluid collection

3
Subscribe