Ignite Creation Date:
2024-05-06 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03562182
Status:
UNKNOWN
Last Update Posted:
2021-10-05
First Post:
2018-05-09
Brief Title:
Effect of Steroid Administration on Maternal Blood Levels of hLPCAT1 mRNA
Sponsor:
Wayne State University
Organization:
Wayne State University
Study Overview
Official Title:
Effect of Steroid Administration on Maternal Blood Levels of hLPCAT1 mRNA
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LPCAT1
Brief Summary:
Neonatal respiratory distress syndrome affects babies who are born preterm and requires them to be placed on a ventilator in the Intensive Care Unit Over 15 million babies were born premature and these numbers have been increasing It is caused by lungs which are still too immature to produce adequate amounts of surfactant This surfactant reduces the alveolar surface tension and maintains the alveoli from collapsing Collapsed alveoli prevent gas exchange and greatly increase work of breathing Surfactant is a biochemical complex made up mostly of phospholipids such as phosphatidylcholine and phosphatidylglycerol and these in turn appear to be synthesized by lysophosphatidylcholine acyltransferase 1 LPCAT 1 The investigators have previously established that hLPCAT1 mRNA in maternal serum correlates with lamellar body count a well established clinical marker of fetal lung maturity
Detailed Description:
OBJECTIVESAIMS
1 Group 1 Determine the serum levels of hLPCAT1 mRNA in pregnant women from 32- 3667 weeks gestation More specifically to determine at what moment in gestation expression spontaneously begins
2 Group 2 Determine how and if serum hLPCAT1 mRNA changes with administration of a course of steroids by measuring its levels before 24hrs after the first dose and 24hrs after the second dose of bethamethasone as well as one and two week after the first dose The investigators seek to understand the effects of the 2nd dose of steroids and determine if once the hLPCAT1 expression begins does it continue or does it turn off again after some time from steroid administration
3 Correlate measures of neonatal outcomes Apgars cord gases need for NICU admission need for respiratory support need for ventilator with levels of hLPCAT1 in labor
METHODOLOGY The first group will consist of patients with normal pregnancies who present for routine prenatal care between 32- 36 67 weeks Once consented and enrolled in the study participants will give a small half a teaspoon blood sample every other week until reaching 37 weeks
In group 2 pregnant women who present for rule-out preterm labor will be offered participation in the study Blood samples will be collected along with all other relevant clinical labs in PAX gene tubes on admission 24hrs and 48hrs after the course of steroids is initiated Samples will also be collected 1 and 2 weeks later to see if steroid effect degrades over time This would have immense clinical implication especially when it comes to rescue doses
Investigators will also correlate measures of neonatal outcomes such as apgar scores blood gases NICU admission need to go on respiratoryventilator support to the most recent maternal serum hLPCAT1 throughout the study If the patient delivers more than one week from the last sample an hLPCAT1 will be acquired during labor
Women with singleton pregnancies and no evidence of diabetes hypertension smoking BMI 35 Hgb 10 gdl or other confounding variables will be admitted to the study In addition a baseline for hLPCAT1 maternal serum mRNA will be established by testing women from 32 - 36 67 weeks gestation All tests will consist of a half teaspoon 25 ml blood collection using PAX gene tubes
Consent will be obtained by the PICo-PIs and by residentsfellows and the signed consent sheet will become part of the chart No remuneration will be offered Investigators will seek 80 volunteers for this study anticipating an approximate drop-out rate of 50 because of compliance issues and early deliveries
1 Group 1 Determine the serum levels of hLPCAT1 mRNA in pregnant women from 32- 3667 weeks gestation More specifically to determine at what moment in gestation expression spontaneously begins
2 Group 2 Determine how and if serum hLPCAT1 mRNA changes with administration of a course of steroids by measuring its levels before 24hrs after the first dose and 24hrs after the second dose of bethamethasone as well as one and two week after the first dose The investigators seek to understand the effects of the 2nd dose of steroids and determine if once the hLPCAT1 expression begins does it continue or does it turn off again after some time from steroid administration
3 Correlate measures of neonatal outcomes Apgars cord gases need for NICU admission need for respiratory support need for ventilator with levels of hLPCAT1 in labor
METHODOLOGY The first group will consist of patients with normal pregnancies who present for routine prenatal care between 32- 36 67 weeks Once consented and enrolled in the study participants will give a small half a teaspoon blood sample every other week until reaching 37 weeks
In group 2 pregnant women who present for rule-out preterm labor will be offered participation in the study Blood samples will be collected along with all other relevant clinical labs in PAX gene tubes on admission 24hrs and 48hrs after the course of steroids is initiated Samples will also be collected 1 and 2 weeks later to see if steroid effect degrades over time This would have immense clinical implication especially when it comes to rescue doses
Investigators will also correlate measures of neonatal outcomes such as apgar scores blood gases NICU admission need to go on respiratoryventilator support to the most recent maternal serum hLPCAT1 throughout the study If the patient delivers more than one week from the last sample an hLPCAT1 will be acquired during labor
Women with singleton pregnancies and no evidence of diabetes hypertension smoking BMI 35 Hgb 10 gdl or other confounding variables will be admitted to the study In addition a baseline for hLPCAT1 maternal serum mRNA will be established by testing women from 32 - 36 67 weeks gestation All tests will consist of a half teaspoon 25 ml blood collection using PAX gene tubes
Consent will be obtained by the PICo-PIs and by residentsfellows and the signed consent sheet will become part of the chart No remuneration will be offered Investigators will seek 80 volunteers for this study anticipating an approximate drop-out rate of 50 because of compliance issues and early deliveries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None