Neoneur Feeding System Functionality in the Clinic (NN200)
Primary Purpose
Feeding Patterns, Feeding; Difficult, Newborn, Feeding Disorder Neonatal
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Feeding Evaluation
Sponsored by
About this trial
This is an interventional supportive care trial for Feeding Patterns
Eligibility 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
Sites / Locations
- Children's Hospital of PhiladelphiaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Feeding Assessment
Arm Description
Feeding assessment of High-risk premature infants
Outcomes
Primary Outcome Measures
Maturation
Neoneur 200 measures are corelated to infant maturation in gestational age
Telehealth functionality
Evaluation of Sending Neoneur 200 data from the bedside to the cloud for used in the hospital and home
Secondary Outcome Measures
Respiratory
The evaluation of Neoneur 200's respiratory sensor to collect accurate data
Full Information
NCT ID
NCT05525091
First Posted
August 30, 2022
Last Updated
September 13, 2023
Sponsor
Neoneur LLC
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR), Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT05525091
Brief Title
Neoneur Feeding System Functionality in the Clinic
Acronym
NN200
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2022 (Actual)
Primary Completion Date
August 14, 2024 (Anticipated)
Study Completion Date
September 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neoneur LLC
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR), Children's Hospital of Philadelphia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Patterns, Feeding; Difficult, Newborn, Feeding Disorder Neonatal
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Feeding Assessment
Arm Type
Experimental
Arm Description
Feeding assessment of High-risk premature infants
Intervention Type
Other
Intervention Name(s)
Feeding Evaluation
Other Intervention Name(s)
Neoneur 200
Intervention Description
Feeding Evaluation with Device
Primary Outcome Measure Information:
Title
Maturation
Description
Neoneur 200 measures are corelated to infant maturation in gestational age
Time Frame
6 weeks of data collection
Title
Telehealth functionality
Description
Evaluation of Sending Neoneur 200 data from the bedside to the cloud for used in the hospital and home
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Respiratory
Description
The evaluation of Neoneur 200's respiratory sensor to collect accurate data
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
10 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Hoedemaker, BS/MBA
Phone
9084004096
Email
choedemaker@neoneur.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Heart
Email
choedemaker-pi@neoneur.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Medoff-Cooper, MSN, PhD
Organizational Affiliation
Children's Hospital of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
08534
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Medoff-Cooper, PhD MSN
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
the results will be available and we will seek publication
Learn more about this trial
Neoneur Feeding System Functionality in the Clinic
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