Fetal Lung MaturityLPCAT1NCT03562182
Effect of Steroid Administration on Maternal Blood Levels of hLPCAT1 mRNA
An observational study of Fetal Lung Maturity and Respiratory Distress Syndrome in Premature Infant, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fetal Lung Maturity, Respiratory Distress Syndrome in Premature Infant
- What is being tested?
- blood draw
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2018to May 2022
- How long will I take part?
- 15 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: Patients who seek obstetrical care at Wayne State/DMC
Who may be able to join
- Singleton pregnancy, no evidence of diabetes, hypertension, smoking, BMI > 35, Hgb < 10 g/dl or other confounding variables
Who cannot join
- Smoking, abnormal gestation, multiple gestatio
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Detroit Medical Ceter
Detroit, Michigan, 48201
Maurice Recanati, MD, 917-331-6203, marecanati@wayne.edu
About this study
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.
Read the detailed description
OBJECTIVES/AIMS
- Group 1: Determine the serum levels of hLPCAT1 mRNA in pregnant women from 32- 36+6/7 weeks gestation. More specifically, to determine at what moment in gestation, expression spontaneously begins.
- 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.
- 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 6/7 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 respiratory/ventilator 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 g/dl 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 +6/7 weeks gestation. All tests will consist of a half teaspoon (2.5 ml) blood collection using PAX gene tubes.
Consent will be obtained by the PI/Co-PI's and by residents/fellows 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.
- Being tested
- blood draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawOther
Blood draw (2.5mL) to assess mRNA LPCAT1 levels
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Maternal levels of LPCAT1 mRNA will be measured in labor and compared to the need for admission to NICU. Data gathered from a chart review.
Measured: Through study completion, within 2 months
Correlate the LPCAT1 mRNA copy number to need for intubation in the nicu
LPCAT1 mRNA levels in labor will be correlated to need for intubation. Data gathered from a chart review.
Measured: Through study completion, within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start18 Jun 2018
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fetal Lung MaturityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 15 Weeks
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurice-Andre Recanati, Wayne State University
- Investigators
- Maurice Recanati, MD, Principal investigator, Assistant Professor OBGYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562182
- Sponsor's protocol ID
- 041717MP2F
- Acronym
- LPCAT1
- Status last verified
- Oct 2021
- First submitted
- 9 May 2018
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data
Publications
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.
PubMed 28926341Harayama 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.
PubMed 19383981Welch 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.
PubMed 25968427Ellis 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.
PubMed 22905292
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Steroid Administration on Maternal Blood Levels of hLPCAT1 mRNA
- ClinicalTrials.gov ID
- NCT03562182
- Acronym / sponsor ID
- LPCAT1 / 041717MP2F
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
OBJECTIVES/AIMS
- Group 1: Determine the serum levels of hLPCAT1 mRNA in pregnant women from 32- 36+6/7 weeks gestation. More specifically, to determine at what moment in gestation, expression spontaneously begins.
- 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.
- 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 6/7 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 respiratory/ventilator 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 g/dl 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 +6/7 weeks gestation. All tests will consist of a half teaspoon (2.5 ml) blood collection using PAX gene tubes.
Consent will be obtained by the PI/Co-PI's and by residents/fellows 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 15 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women Receiving Antenatal Steroids | – | Other: blood drawGroup 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 | – | Other: blood draw1) 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients who seek obstetrical care at Wayne State/DMC
Key inclusion criteria (1 listed)
- Singleton pregnancy, no evidence of diabetes, hypertension, smoking, BMI > 35, Hgb < 10 g/dl or other confounding variables
Key exclusion criteria (1 listed)
- Smoking, abnormal gestation, multiple gestatio
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawBlood draw (2.5mL) to assess mRNA LPCAT1 levels | Other | Normal Pregnancy Controls, Women Receiving Antenatal Steroids |
Primary outcome
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.
The investigators will measure the level of LPCAT1 mRNA in maternal plasma before and after the administration of antenatal steroids.
2 secondary outcomes
Number of participants admitted to the NICU with high LPCAT1 mRNA levels
Time frame: Through study completion, within 2 months
Correlate the LPCAT1 mRNA copy number to need for intubation in the nicu
Time frame: Through study completion, within 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Results publication: PubMed 28926341Welch 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.
- Results publication: PubMed 19383981Harayama 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.
- Results publication: PubMed 25968427Welch 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.
- Results publication: PubMed 22905292Ellis 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.
- Individual participant dataSharing planned: No. No plan to share data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice Recanati, MD principal investigator
Assistant Professor OBGYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Lung Maturity and Respiratory Distress Syndrome in Premature Infant, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maurice Recanati, MD (9173316203, marecanati@wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562182, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.