Neoneur Feeding System Functionality in the Clinic (NN200)

Neoneur

Status

Enrolling

Conditions

Feeding Disorder Neonatal

Feeding; Difficult, Newborn

Feeding Patterns

Treatments

Other: Feeding Evaluation

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT05525091

NN2022-01

1R44NR020275-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

1 day to 10 weeks old

Volunteers

No Healthy Volunteers

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