Feeding; Difficult, Newborn, Feeding Disorder Neonatal, Feeding Patterns
Conditions
Brief summary
Prospective data collection using the Neoneur Feeding System to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase II SBIR trial
Detailed description
The consented infant's assigned Speech Language Pathologist will use the Neoneur Feeding System 2-3 times a week from initiation of oral feeding until discharge, if oral feeding is prescribed. It can be used either as a special consult, or during routine care. The feeding is performed by the Speech Language Pathologist assigned to the infant. There will be no change in the infant's feeding plan. For infants consented to participate in the study, their feeding will include the Neoneur feeding system inserted between the nipple and bottle. When the Neoneur is inserted, it will capture both the suck and swallow changes (oral cavity pressure), and respiration (temperature changes) patterns.
Interventions
OTHERFeeding Evaluation
Feeding Evaluation with Device
Sponsors
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Children's Hospital of Philadelphia
Neoneur LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 10 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maturation | 6 weeks of data collection | Neoneur 200 measures are corelated to infant maturation in gestational age |
| Telehealth functionality | 6 months | Evaluation of Sending Neoneur 200 data from the bedside to the cloud for used in the hospital and home |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory | 6 months | The evaluation of Neoneur 200's respiratory sensor to collect accurate data |
Countries
United States
Contacts
Primary ContactCaroline Hoedemaker, BS/MBA
Backup ContactKaren Heart
Outcome results
None listed