Neoneur Feeding System Functionality in the Clinic

Last updated: September 13, 2023
Sponsor: Neoneur LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Feeding Evaluation

Clinical Study ID

NCT05525091
NN2022-01
1R44NR020275-01
  • Ages 1-10
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Preterm infants: requiring tube assisted feeding while in the NICU, gestational age atbirth =<34 week, extubated by term
  • Infants with CHD: requiring surgery during the first month of life, gestational age > 37 weeks

Exclusion

Exclusion Criteria:

  • Premature infants: craniofacial anomalies, infants with grade IV intraventricularhemorrhage, 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, requiringadditional surgery

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Feeding Evaluation
Phase:
Study Start date:
July 14, 2022
Estimated Completion Date:
September 14, 2024

Study 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.

Connect with a study center

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 08534
    United States

    Active - Recruiting

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