The purpose of this study is to examine the efficacy of a specially-constructed crib mattress that delivers gentle vibrations (stochastic vibrotactile stimulation) as a complementary, non-pharmacological intervention for treating drug withdrawal in newborns exposed to opioids in utero.
Age range
1 Hour – 18 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants Administered Morphine Treatment
Timeframe: Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days
Cumulative Pharmacological Treatment- Morphine Dose
Timeframe: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Hospitalization Length of Stay
Timeframe: Day of life infants discharged home, which is an expected mean of 21 days.
Hospitalization Length of Stay for Untreated Infants
Timeframe: Day of life untreated infants discharged home, which is an expected mean of 21 days.
Hospitalization Length of Stay for Treated Infants
Timeframe: Day of life treated infants discharged home, which is an expected mean of 21 days.
Length of Pharmacological Treatment-Duration
Timeframe: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Trajectory of Symptom Severity Among Treated Infants
Timeframe: Day of life infant started morphine treatment
Velocity of Weight Gain
Timeframe: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Neurobehavioral Outcomes Assessment
Timeframe: 6 month and 12 months of life