Recruiting

Steroid Administration

Sponsor:

Wayne State University

Code:

NCT03562182

Conditions

Fetal Lung Maturity

Respiratory Distress Syndrome in Premature Infant

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

blood draw

Study Details

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

Study ID

NCT03562182

Start date

Jun 18, 2018

Status verified date

Oct, 2021

Completion date

May, 2022

Anticipated

Primary completion date

May, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking, abnormal gestation, multiple gestatio

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

blood draw

Blood draw (2.5mL) to assess mRNA LPCAT1 levels

Primary outcome measure

  • Change in LPCAT1 mRNA levels in maternal plasma after antenatal steroid administration [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Maurice Recanati, MD

9173316203marecanati@wayne.edu

Locations

Detroit Medical Ceter

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Maurice Recanati, MD

917-331-6203marecanati@wayne.edu

More Information

Sponsor

Wayne State University

Last update posted

Oct 5, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2021-10-05.