| NCT ID | NCT07610746 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Neonatal Opioid Withdrawal |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2026-08-11 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 46 participants in total. It began in 2026-08-11 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will use a new device to measure blood flow and oxygen levels in the brains of newborn infants who have had exposure to opioid medications in the womb, compared to newborns who have not had any exposure.
Eligibility Criteria
Inclusion Criteria: Infants with prenatal opioid exposure: * Term born or near-term born (\> 36w) infants * Birth weight \> 2 Kg * History of prenatal opioid exposure Control infants: * Term born or near-term born (\> 36w) infants * Birth weight \> 2 Kg Mothers of infants with prenatal opioid exposure: * greater or equal to 19 years of age * Use of opioid substances during pregnancy - Defined as pregnant women who 1) are clinically diagnosed as having an opioid use disorder and are on methadone or buprenorphine maintenance program or 2) have a urine drug test positive for prescribed or illicit opioids Mothers of control infants: * greater than or equal to 19 years of age Exclusion Criteria: Infants with prenatal opioid exposure: * APGAR score at 5 min \< 7 * Any major congenital malformations or genetic syndromes * Need for positive pressure ventilation in the delivery room Control infants: * APGAR score at 5 min \< 7 * Any major congenital malformations or genetic syndromes * Need for positive pressure ventilation in the delivery room * Any history of prenatal opioid exposure Mothers of infants with prenatal opioid exposure: * Major maternal illness during pregnancy or delivery that could impact infant cerebral perfusion as deemed by the study investigators (e.g. uterine rupture or preeclampsia) Mothers of control infants: * Major maternal illness during pregnancy or delivery that could impact infant cerebral perfusion as deemed by the study investigators (e.g. uterine rupture or preeclampsia) * Tobacco, SSRI or any opioid use during pregnancy
Contact & Investigator
Anna Thomas, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT07610746 clinical trial?
This trial is open to participants of all sexes, up to 1 Day, studying Neonatal Opioid Withdrawal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07610746 currently recruiting?
Yes, NCT07610746 is actively recruiting participants. Contact the research team at aeschwar@iu.edu for enrollment information.
Where is the NCT07610746 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT07610746 clinical trial?
NCT07610746 is sponsored by Indiana University. The principal investigator is Anna Thomas, MD at Indiana University. The trial plans to enroll 46 participants.