Using the Neoneur Feeding System to evaluate feeding in infants
Neoneur Feeding System Functionality in the Clinic - Investigating Assessment of Quantifying Feeding Functionality in Premature and Cardiac Surgery Neonates in Comparison to Dr. Medoff-Cooper's Past Research
NA · Neoneur LLC · NCT05525091
This study is testing a new feeding system to see how it can help track feeding patterns in preterm babies and those with certain heart conditions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 1 Day to 10 Weeks |
| Sex | All |
| Sponsor | Neoneur LLC (industry) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05525091 on ClinicalTrials.gov |
What this trial studies
This study involves the use of the Neoneur Feeding System to collect prospective data on feeding patterns in preterm and certain congenital heart disease infants. The assigned Speech Language Pathologist will utilize the device 2-3 times a week during the infants' oral feeding process until discharge, without altering their feeding plan. The device captures critical data on suck, swallow, and respiration patterns to assess its functionality and correlate findings with historical data, paving the way for future trials.
Who should consider this trial
Good fit: Ideal candidates include preterm infants requiring tube-assisted feeding in the NICU or infants with congenital heart disease needing surgery within the first month of life.
Not a fit: Patients with craniofacial anomalies, severe intraventricular hemorrhage, or other significant health complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance feeding strategies for infants with feeding disorders, improving their overall health outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in evaluating feeding patterns in infants, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm infants: requiring tube assisted feeding while in the NICU, gestational age at birth =\<34 week, extubated by term * Infants with CHD: requiring surgery during the first month of life, gestational age \> 37 weeks Exclusion Criteria: * Premature infants: craniofacial anomalies, infants with grade IV intraventricular hemorrhage, apgar \< 5 at 5 minutes, short gut syndrome, history of NEC * Infants with CHD: no other congenital anomalies, no history of major neurologic insult , listed for heart transplant, history of ECMO, intubated for \> 4 weeks, requiring additional surgery
Where this trial is running
Philadelphia, Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Barbara Medoff-Cooper, MSN, PhD — Children's Hospital of Pennsylvania
- Study coordinator: Caroline Hoedemaker, BS/MBA
- Email: choedemaker@neoneur.com
- Phone: 9084004096
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.
Conditions: Feeding Patterns, Feeding, Difficult, Newborn, Feeding Disorder Neonatal