Cerebral Physiology of NOWS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorIndiana University

About this trial

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

Qualifiers

Term born or near-term born (> 36w) infants

Birth weight > 2 Kg

History of prenatal opioid exposure

Term born or near-term born (> 36w) infants

Disqualifiers

APGAR score at 5 min < 7

Any major congenital malformations or genetic syndromes

Need for positive pressure ventilation in the delivery room

APGAR score at 5 min < 7

Trial design

Treatments tested in this trial

  • FD-NIRS and DCS

Treatment groups

46 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Indiana University

Lead sponsor

Indiana Clinical and Translational Sciences Institute

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator