Monitoring vital signs in healthy newborns
Continuous Vital Sign Monitoring in Newborns
This study is testing a new way to continuously monitor the vital signs of healthy newborns in the hospital to see if it can help catch any problems early and fit into the usual care routine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 0 Hours to 12 Hours |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 2 sites (New Hyde Park, New York and 1 other locations) |
| Trial ID | NCT04154618 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and usability of continuous wireless vital sign monitoring for healthy newborns during their birth hospitalization. It aims to understand how routine monitoring can be integrated into existing workflows and its potential for early detection of undiagnosed problems. All participating infants will receive standard newborn nursing care, and monitoring data will be analyzed in real-time to alert nurses of any out-of-range vital signs. Surveys will be completed by nurses and parents to assess their experiences with this monitoring approach.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy infants less than 12 hours old, born at 36 weeks gestation or more, and expected to be admitted to the Well Baby Nursery.
Not a fit: Patients who may not benefit from this study include those requiring non-routine medical care, those admitted to the NICU, or those from multiple births.
Why it matters
Potential benefit: If successful, this could enhance the early detection of complications in newborns, leading to improved outcomes.
How similar studies have performed: Other studies have shown promise in continuous monitoring approaches, but this specific application in healthy newborns is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy infants \<12 hours of age * Expected to be admitted to the Well Baby Nursery * 36 or more weeks gestation at birth * Mother at least 18 years of age Exclusion Criteria: * Infants requiring any non-routine medical care or observation * Neonatal Intensive Care Unit (NICU) or Special Care Nursery admission * Multiple birth
Where this trial is running
New Hyde Park, New York and 1 other locations
- Cohen Children's Medical Center of New York — New Hyde Park, New York, United States (Recruiting)
- Phelps Hospital — Sleepy Hollow, New York, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Barry Weinberger, MD
- Email: BWeinberger@northwell.edu
- Phone: 718-470-3440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.