Neonatal DiseaseNCT06569641
Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System
A study testing Neoneur Feeding System in people with Neonatal Disease and Post-Surgical Complication, run by Neoneur LLC.
Trial summary
A prospective non-randomized longitudinal design of 30-40 infants from initiation of oral feeding until discharge to track feeding changes as a potential indicator of surgical recovery. Read more about this study
- Who is it for?
- Ages 1 day to 50 days
- Conditions the study is for
- Neonatal Disease, Post-Surgical Complication, Cardiac Disease
- What is being tested?
- Neoneur Feeding System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Sep 2026
- 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 50 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Complex congenital heart disease requiring cardiac surgery during first month of life
- Gestational age>=35 weeks at birth
Who cannot join
- No other major non-cardiac congenital anomalies,
- No history of major neurologic insult
- Not listed for a heart transplant,
- Not intubated for >4 weeks post-surgery,
- Not trisomy 13, 18, and 21
- No cleft lip/palate.
About this study
A prospective non-randomized longitudinal design of 30-40 infants from initiation of oral feeding until discharge to track feeding changes as a potential indicator of surgical recovery.
Read the detailed description
Safe oral feeding is a challenge for infants born with complex congenital heart disease (CHD). These infants are likely to require tube-assisted feeding at the initiation of enteral feeding and struggle to transition to full oral feeding. Infant post-surgery recovery includes a safe transition to oral feeding without respiratory risk. Neoneur Feeding System, consists of a novel hand-held, mobile phone application, and a cloud based computation, which innovatively measures patterns of oral cavity pressure synchronized with respiration, providing a quantitative assessment of feeding patterns. Yet there has been no quantitative means of measuring this recovery process. The concept of post-surgical recovery model is not new. The adult literature is replete with physiologic and behavioral indicators of recovery. More recently Roy and colleagues introduced a recovery model for post-surgical CHD children to adults using a component metrics of physiologic parameters. We are proposing to develop an infant specific recovery model using feeding patterns using data generated by the Neoneur device. The model, using the lens of behavioral organization, will include feeding measurements from initiation of oral feeding to discharge.
This study will evaluate the association between feeding recovery and clinical assessment of infant behaviors as measured in a brief survey to assess irritability, ability to be soothed, alertness, non-nutritive sucking, and muscle tone. Forty infants will be recruited from the PCICU-CSD at MUSC to capture thirty usable infant sets of Neoneur data from the PCICU-CSD at MUSC. This data will be assessed using the Neoneur Feeding System to create a model of feeding recovery.
- Being tested
- Neoneur Feeding System
- Keywords
- Recovery
- Medical subject headings
- Infant, Newborn, Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoneur Feeding SystemDevice
The Neoneur Feeding System is placed between a nipple and a bottle, and used to measure feeding skill patterns.
| Study group | Role | What they receive |
|---|---|---|
| Feeding Assessment | Experimental | While Feeding, use Neoneur Feeding System to measure feeding patterns (suck, swallow, and breathing) Receives: Device: Neoneur Feeding System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the validity in use of feeding parameters to measure recovery progress for infants with complex CHD
A comparison of feeding patterns (oral cavity pressure changes in suck and swallow, and respiratory patterns) and changes as an infant recovers and determination if there is a greater than 60% concordance with behavioral survey measuring recovery.
Measured: 12 months
Secondary outcomes (1)
Comparison of Neoneur Feeding system measurements seen in post surgical infants, to match clinical observation of suck, swallow, and breathing during oral feeding.
70% concordance between Neoneur Feeding Trace, and clinical observation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DiseaseStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Infant feeding patterns during standard care. The Neoneur Feeding System captures data such the changes in these feeding patterns can be measured. This study is capturing longitudinal changes over a short period of time, to see if they reflect infant recovery from surgery.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neoneur LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569641
- Sponsor's protocol ID
- C03101
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All Protocol, Inform Consent, and Final data will be shared with the research sites for their use in publications, and as required by the NIH.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System
- ClinicalTrials.gov ID
- NCT06569641
- Acronym / sponsor ID
- C03101
- Keywords
- Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Neoneur LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Aug 2024 (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.
A prospective non-randomized longitudinal design of 30-40 infants from initiation of oral feeding until discharge to track feeding changes as a potential indicator of surgical recovery.
Detailed description
Safe oral feeding is a challenge for infants born with complex congenital heart disease (CHD). These infants are likely to require tube-assisted feeding at the initiation of enteral feeding and struggle to transition to full oral feeding. Infant post-surgery recovery includes a safe transition to oral feeding without respiratory risk. Neoneur Feeding System, consists of a novel hand-held, mobile phone application, and a cloud based computation, which innovatively measures patterns of oral cavity pressure synchronized with respiration, providing a quantitative assessment of feeding patterns. Yet there has been no quantitative means of measuring this recovery process. The concept of post-surgical recovery model is not new. The adult literature is replete with physiologic and behavioral indicators of recovery. More recently Roy and colleagues introduced a recovery model for post-surgical CHD children to adults using a component metrics of physiologic parameters. We are proposing to develop an infant specific recovery model using feeding patterns using data generated by the Neoneur device. The model, using the lens of behavioral organization, will include feeding measurements from initiation of oral feeding to discharge.
This study will evaluate the association between feeding recovery and clinical assessment of infant behaviors as measured in a brief survey to assess irritability, ability to be soothed, alertness, non-nutritive sucking, and muscle tone. Forty infants will be recruited from the PCICU-CSD at MUSC to capture thirty usable infant sets of Neoneur data from the PCICU-CSD at MUSC. This data will be assessed using the Neoneur Feeding System to create a model of feeding recovery.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Infant feeding patterns during standard care. The Neoneur Feeding System captures data such the changes in these feeding patterns can be measured. This study is capturing longitudinal changes over a short period of time, to see if they reflect infant recovery from surgery.
| Arm | Type | Receives |
|---|---|---|
| Feeding Assessment | Experimental | Device: Neoneur Feeding SystemWhile Feeding, use Neoneur Feeding System to measure feeding patterns (suck, swallow, and breathing) |
Who may qualify
- Ages
- 1 day to 50 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Complex congenital heart disease requiring cardiac surgery during first month of life
- Gestational age>=35 weeks at birth
Key exclusion criteria (6 listed)
- No other major non-cardiac congenital anomalies,
- No history of major neurologic insult
- Not listed for a heart transplant,
- Not intubated for >4 weeks post-surgery,
- Not trisomy 13, 18, and 21
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 |
|---|---|---|
| Neoneur Feeding SystemThe Neoneur Feeding System is placed between a nipple and a bottle, and used to measure feeding skill patterns. | Device | Feeding Assessment |
Primary outcome
To test the validity in use of feeding parameters to measure recovery progress for infants with complex CHD
Time frame: 12 months
A comparison of feeding patterns (oral cavity pressure changes in suck and swallow, and respiratory patterns) and changes as an infant recovers and determination if there is a greater than 60% concordance with behavioral survey measuring recovery.
1 secondary outcome
Comparison of Neoneur Feeding system measurements seen in post surgical infants, to match clinical observation of suck, swallow, and breathing during oral feeding.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No. All Protocol, Inform Consent, and Final data will be shared with the research sites for their use in publications, and as required by the NIH.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Neoneur Feeding System in people with Neonatal Disease and Post-Surgical Complication, run by Neoneur LLC.
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 6 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 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test the validity in use of feeding parameters to measure recovery progress for infants with complex CHD (time frame: 12 months). 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 26 Aug 2024.