MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-5
SponsorMilton S. Hershey Medical Center
About this trial
Infants with neonatal abstinence syndrome (NAS) experience prolonged hospital stays and poor neurodevelopmental outcomes, in-part because of the lack of accurate, individualized, biologic assessments available to manage this increasingly common medical condition. The proposed study will define the molecular mechanisms that regulate the response to opioid withdrawal in the developing brain by focusing on three candidate microRNAs (let-7a, miR-146a, miR-192) that have been shown to respond to opioid exposure in animal models and adults, and are impacted in both my preliminary study of infants with NAS, and my human neural progenitor cell (NPC) design of opioid withdrawal. By determining the mechanism through which microRNAs impact NPC differentiation in opioid withdrawal, and determining whether exosomal salivary microRNA levels predict treatment dose and neurodevelopmental outcomes in infants with NAS, this study will enhance our knowledge of NAS-related biology and identify potential biomarkers that could improve medical care for this important medical condition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newborns ≥35weeks gestation with chronic in-utero opioid exposure (>1month of gestation exposure). Maternal exposure will be determined by evaluating the medical records for maternal medication use, maternal urine toxicology and neonatal meconium toxicology results per standard clinical care
Neonates born at Penn State Hershey Medical Center or transferred at <48 hours after birth
Mothers with chronic in-utero opioid use during pregnancy ( ≥1month of gestation)
Disqualifiers
<35 week gestation
Infant required mechanical ventilation or non-invasive mechanical support
Infant exposure to magnesium sulfate
Opioid-exposed neonates who are actively receiving dextrose infusion for persistent neonatal hypoglycemia at the time of enrollment (<48hours after birth).
Trial population
Infants enrolled into the study were exposed to opiates in-utero for at least one month of gestation. All infants enrolled meet the eligibility criteria listed above.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Buccal swab saliva for further genetic testing
GeneticGenetic testing. Whole saliva RNA will be isolated for downstream microRNA quantification.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Infants exposed to in utero opiates1 intervention
Trial outcomes
Primary outcomes
1
Neurodevelopmental outcome scores
Measured by Ages and Stages Questionnaire-3, score scale 0-60
Time frame
6 months of age2
Maximum concentration of morphine required for withdrawal symptom control
Measured in mg/kg/ml
Time frame
Measured during the course of hospital stay3
Salivary microRNA level let-7a
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Time frame
Buccal swab collected within 96 hrs of life and at discharge4
Salivary level of microRNA-146a
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Time frame
Buccal swab collected within 96 hrs of life and at dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Milton S. Hershey Medical Center
Lead sponsor
Penn State University
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov