Non-drug care plus targeted medicine for newborns with opioid withdrawal
Incorporating nonpharmacologic approaches into a comparative effectiveness pharmacologic trial for neonates with neonatal opioid withdrawal syndrome (NOWS)
This project combines comfort-focused care with giving medicine only when needed to help newborns with opioid withdrawal symptoms recover and go home sooner.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Indiana University Indianapolis NIH-funded |
| Lab location | 1 site (Indianapolis, United States) |
| Project ID | NIH-11169061 on NIH RePORTER |
What this research studies
This clinical project enrolls newborns with neonatal opioid withdrawal syndrome (NOWS) who have moderate to severe withdrawal symptoms based on a modified Finnegan score. Babies are randomized to either a standard scheduled morphine dosing/weaning plan or to an 'optimal' plan that provides morphine only when symptoms cannot be controlled with nonpharmacologic care. Nonpharmacologic measures such as swaddling, skin-to-skin contact, feeding support, and a quiet environment are emphasized before giving medicine in the optimal arm. Researchers follow symptom scores, medication use, and length of hospital stay to compare safety and recovery between the approaches.
Who could benefit from this research
Good fit: Ideal candidates are newborn infants diagnosed with NOWS who show moderate to severe withdrawal signs and are born at or transferred to participating hospitals.
Not a fit: Babies with mild or no withdrawal symptoms, those with major medical complications, or those born outside participating centers may not be helped by or eligible for this approach.
Why it matters
Potential benefit: If successful, this approach could reduce medication exposure and shorten hospital stays for infants with NOWS.
How similar studies have performed: Earlier pilot studies and standardized weaning programs have lowered length of stay and nonpharmacologic care has shown promise, but larger comparative trials are still limited.
Where this research is happening
Indianapolis, United States
- Indiana University Indianapolis — Indianapolis, United States (Active)
Researchers
- Principal investigator: Sokol, Gregory M. — Indiana University Indianapolis
- Study coordinator: Sokol, Gregory M.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.