NCT03064607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2010

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2018

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

7.3 years

First QC Date

February 22, 2017

Last Update Submit

February 15, 2019

Conditions

NeurodegenerationGeneral Anesthesia

Keywords

NeonatesbiomarkersEXIT procedureCesarean Section

Outcome Measures

Primary Outcomes (1)

  • S100β Umbilical

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

    1 day

Secondary Outcomes (3)

  • S100β Amniotic

    1 day

  • S100β Blood

    1 day

  • Blood gas

    1 day

Study Arms (1)

pregnant women

Women undergoing c-section or EXIT procedure

Other: Fluid collection

Interventions

Fluid collectionOTHER

Fluids tested for biomarker S100beta

pregnant women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pregnant women

You may qualify if:

  • Women delivering a child via cesarean section or EXIT procedure
  • Informed consent

You may not qualify if:

  • Known fetal neurologic defect
  • Known maternal neurologic abnormality
  • Sensitivity or allergy to medications used in the study
  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Nerve Degeneration

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Huafeng Wei, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2017

First Posted

February 27, 2017

Study Start

November 5, 2010

Primary Completion

February 6, 2018

Study Completion

February 6, 2018

Last Updated

February 19, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)