Effect of Steroid Administration on Maternal Blood Levels of hLPCAT1 mRNA

NCT03562182 | Unknown

• 1 other identifier: 041717MP2F
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Lung Maturity; Respiratory Distress Syndrome in Premature Infant

Outcome Measures

Primary Outcomes (1)

• Change in LPCAT1 mRNA levels in maternal plasma after antenatal steroid administration

  The investigators will measure the level of LPCAT1 mRNA in maternal plasma before and after the administration of antenatal steroids.

  The time points will be a baseline before steroids, 24h after the first dose, 24h after the second dose, a week after steroids and two weeks after steroids.

Secondary Outcomes (2)

• Number of participants admitted to the NICU with high LPCAT1 mRNA levels

  Through study completion, within 2 months

• Correlate the LPCAT1 mRNA copy number to need for intubation in the nicu

  Through study completion, within 2 months

Study Arms (2)

Women Receiving Antenatal Steroids

Group 2: Determine how (and if) serum hLPCAT1 mRNA changes with administration of a course of steroids by measuring its plasma 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. This is accomplished through a simple blood draw. We 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.

Other: blood draw

Normal Pregnancy Controls

1\) Group 1: Determine the plasma levels of hLPCAT1 mRNA in pregnant women from 32- 36+6/7 weeks gestation. This is accomplished through a simple blood draw. More specifically, we seek to find out, at what moment in gestation, expression spontaneously begins.

Other: blood draw

Interventions

blood draw OTHER

Blood draw (2.5mL) to assess mRNA LPCAT1 levels

Normal Pregnancy Controls; Women Receiving Antenatal Steroids

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who seek obstetrical care at Wayne State/DMC

You may qualify if:

• Singleton pregnancy, no evidence of diabetes, hypertension, smoking, BMI \> 35, Hgb \< 10 g/dl or other confounding variables

You may not qualify if:

• Smoking, abnormal gestation, multiple gestatio

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Detroit Medical Ceter

Detroit, Michigan, 48201, United States

RECRUITING

Related Publications (4)

• Welch RA, Recanati MA, Welch KC, Shaw MK. Maternal plasma LPCAT 1 mRNA correlates with lamellar body count. J Perinat Med. 2018 May 24;46(4):429-431. doi: 10.1515/jpm-2017-0057.

  PMID: 28926341 RESULT

• Harayama T, Shindou H, Shimizu T. Biosynthesis of phosphatidylcholine by human lysophosphatidylcholine acyltransferase 1. J Lipid Res. 2009 Sep;50(9):1824-31. doi: 10.1194/jlr.M800500-JLR200. Epub 2009 Apr 21.

  PMID: 19383981 RESULT

• Welch RA, Shaw MK, Welch KC. Amniotic fluid LPCAT1 mRNA correlates with the lamellar body count. J Perinat Med. 2016 Jul 1;44(5):531-2. doi: 10.1515/jpm-2015-0008.

  PMID: 25968427 RESULT

• Ellis B, Kaercher L, Snavely C, Zhao Y, Zou C. Lipopolysaccharide triggers nuclear import of Lpcat1 to regulate inducible gene expression in lung epithelia. World J Biol Chem. 2012 Jul 26;3(7):159-66. doi: 10.4331/wjbc.v3.i7.159.

  PMID: 22905292 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

LPCAT1 mRNA extracted from maternal plasma

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Maurice Recanati, MD

  Assistant Professor OBGYN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurice Recanati, MD

CONTACT

9173316203; marecanati@wayne.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Clinical Educator

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 19, 2018
• Study Start: June 18, 2018
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)