An observational study in Neonatal Respiratory Distress Syndrome, sponsored by Indiana University. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-28.
Sponsored by Indiana University · Observational
The objective of this project is to evaluate clinical significance of measuring maternal blood estriol levels, after the administration of antenatal corticosteroids to enhance lung maturity. The investigators will test for associations of the change in maternal estriol with the development of respiratory distress syndrome. The investigators are also interested in determining whether salivary estriol is a valid surrogate to estriol blood assays. In addition the investigators will correlate these changes to pharmacokinetic (PK), pharmacodynamics (PD), and pharmacogenetic measures of betamethasone administration and fetal respiratory outcome
We will obtain serum and saliva for estriol measurement before or within 2 hours of antenatal corticosteroid administration and about 24 hours after each dose is given.
Women who consent to an optional PK portion of the study will have plasma samples obtained pre-dose and then on a schedule of approximately 0.5-2, 4-8, 10-15, 22-24 hours after the first dose and then 6-8, 24, and 48 hours after the 2nd dose. One sample will be collected in each of these times.
A sample of whole blood will be obtained for DNA isolation. At the time of delivery, umbilical cord blood will be collected before being discarded for DNA and plasma. If we are unable to obtain umbilical cord blood, a buccal swab will be collected from the baby for DNA extraction.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 160 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
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Mothers with preterm labor (23 - 34 weeks) on antenatal corticosteroid for prevention of neonatal respiratory distress syndrome will be recruited
Exclusion Criteria:
Maternal age \<18 years old
Serum Estriol measurement via different assays is complex, expensive, labor intensive, time consuming, and generally performed at specific reference labs. Salivary Estriol level is an ideal potential surrogate for serum Estriol. It is convenient, non-invasive, and expedient. It may not, however, be as sensitive as serum estriol concentrations at detecting the association with glucocorticoid response. This study will collect both samples to determine which one is better suited for clinical use in this condition.
we will determine if changes in maternal serum estriol represent a biomarker of response to antenatal corticosteroids as evidenced by neonatal development of RDS
we will determine if pharmacokinetic parameters and neonatal outcomes after antenatal corticosteroid use are associated with genetic polymorphisms in drug metabolizing enzymes, transporters, and steroid pathway genes
we will determine if maternal betamethasone concentrations and genetics are associated with maternal estriol changes or RDS development
Respiratory distress syndrome
Respiratory Distress Syndrome is diagnosed clinically, by need for mechanical ventilation and oxygen for at least 48 hours, and the presence of radiologic chest findings.
Time frame: At least 30 days after delivery, the maternal and neonatal charts will be reviewed
Plan to share: Yes — Will plan to deposit any genetic information into appropriate repository like dbgap. Other data potentially available upon request.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Indiana University