Feeding PatternsNN200NCT05525091
Neoneur Feeding System Functionality in the Clinic
A study testing Feeding Evaluation in people with Feeding Patterns and Feeding; Difficult, Newborn, run by Neoneur LLC at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 day to 10 weeks
- Conditions the study is for
- Feeding Patterns, Feeding; Difficult, Newborn, Feeding Disorder Neonatal
- What is being tested?
- Feeding Evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 14 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 10 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Karen Heart contact
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 08534
Barbara Medoff-Cooper, PhD MSN
About this study
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
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
Read the 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.
- Being tested
- Feeding Evaluation
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding EvaluationOther
Also called Neoneur 200
Feeding Evaluation with Device
| Study group | Role | What they receive |
|---|---|---|
| Feeding Assessment | Experimental | Feeding assessment of High-risk premature infants Receives: Other: Feeding Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maturation
Neoneur 200 measures are corelated to infant maturation in gestational age
Measured: 6 weeks of data collection
Telehealth functionality
Evaluation of Sending Neoneur 200 data from the bedside to the cloud for used in the hospital and home
Measured: 6 months
Secondary outcomes (1)
Respiratory
The evaluation of Neoneur 200's respiratory sensor to collect accurate data
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start14 Jul 2022
- Primary completion14 Aug 2024 (estimated)
- Study completion14 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding PatternsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neoneur LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR), Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Barbara Medoff-Cooper, MSN, PhD, Principal investigator, Children's Hospital of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525091
- Sponsor's protocol ID
- NN2022-01
- Other IDs
- 1R44NR020275-01
- Acronym
- NN200
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the results will be available and we will seek publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05525091
- Acronym / sponsor ID
- NN200 / NN2022-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Neoneur LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR), Children's Hospital of Philadelphia
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 14 Aug 2024 (estimated)
- Study completion
- 14 Sep 2024 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feeding Assessment | Experimental | Other: Feeding EvaluationFeeding assessment of High-risk premature infants |
Who may qualify
- Ages
- 1 day to 10 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeding EvaluationAlso: Neoneur 200Feeding Evaluation with Device | Other | Feeding Assessment |
Primary outcome
Maturation
Time frame: 6 weeks of data collection
Neoneur 200 measures are corelated to infant maturation in gestational age
Telehealth functionality
Time frame: 6 months
Evaluation of Sending Neoneur 200 data from the bedside to the cloud for used in the hospital and home
1 secondary outcome
Respiratory
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No. the results will be available and we will seek publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Heart contact
Barbara Medoff-Cooper, MSN, PhD principal investigator
Children's Hospital of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding Evaluation in people with Feeding Patterns and Feeding; Difficult, Newborn, run by Neoneur LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Hoedemaker, BS/MBA (9084004096, choedemaker@neoneur.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maturation (time frame: 6 weeks of data collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.