Recruiting

Neoneur Feeding System

Sponsor:

Neoneur LLC

Code:

NCT05525091

Conditions

Feeding Patterns

Feeding; Difficult, Newborn

Feeding Disorder Neonatal

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Feeding Evaluation

Study Details

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

Conditions

Feeding Patterns

Feeding; Difficult, Newborn

Feeding Disorder Neonatal

Study ID

NCT05525091

Start date

Jul 14, 2022

Status verified date

Sep, 2023

Completion date

Sep 14, 2024

Anticipated

Primary completion date

Aug 14, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Feeding Assessment

Feeding assessment of High-risk premature infants

Interventions

Feeding Evaluation

Feeding Evaluation with Device

Primary outcome measure

  • Maturation [ Time Frame: 6 weeks of data collection ]
  • Telehealth functionality [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Caroline Hoedemaker, BS/MBA

9084004096choedemaker@neoneur.com

Karen Heart

choedemaker-pi@neoneur.com

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 08534

More Information

Sponsor

Neoneur LLC

Last update posted

Sep 15, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Neoneur LLC on 2023-09-15.