PrematurityNCT04256889
Use Of Nfant(R) Technology Feeding System For Infants Less Than 30 Weeks GA
A study testing nfant(R) feeding system in people with Prematurity and Extreme Prematurity, run by Woman's at 1 site in United States.
Trial summary
The purpose of the study is to utilize the objective data provided by the nfant® suite of products, along with current NICU visual assessment and cue-based feeding practices, in order to determine if feeding performance outcomes and clinical decision making for individualized feeding plans for premature infants born… Read more about this study
- Who is it for?
- Ages 22 to 29 weeks
- Conditions the study is for
- Prematurity, Extreme Prematurity
- What is being tested?
- nfant(R) feeding system
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 13 Mar 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 22 to 29 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants less than or equal to 29 6/7 weeks gestation at birth
Who cannot join
- Infants 30 weeks or greater gestation at birth
- Infants with known or suspected congenital anomalies or chromosomal abnormalities
- Infants with diagnoses known to interfere with oral feeding, including, but not limited to cleft lip. cleft palate, gastroschisis, Tracheoesophageal fistula, micrognathia.
- History of Intraventricular hemorrhage Grade 3 or 4 or Periventricular Leukomalacia
- Infants with known diagnoses known to interfere with Gastrointestinal absorption, including, but not limited to, Necrotizing Enterocolitis requiring surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Nfant(R) Technology Feeding System As An Adjunct To Visual Assessment And Cue-Based Feedings For Infants Born Less Than 30 Weeks Gestational Age (GA)
The purpose of the study is to utilize the objective data provided by the nfant® suite of products, along with current NICU visual assessment and cue-based feeding practices, in order to determine if feeding performance outcomes and clinical decision making for individualized feeding plans for premature infants born less than 30 weeks PMA are impacted.
Read the detailed description
Will obtain 5 official readings using the nfant(R) technology: baseline between 31 0/7 weeks and 32 0/7 weeks Post-Menstrual Age (PMA) with No Flow nipple, Cue-Based Feeding Readiness Reading with No Flow nipple no sooner than 33 0/7 weeks PMA, Post-Sequencing Reading with Extra Slow Flow nipple, Slow Flow nipple Reading, and Standard nipple Reading. The technology will also be utilized between readings 2 to 3 times a week. Phone Follow-up 2 question survey will be administered 21 days after discharge from Neonatal Intensive Care Unit.This survey entails routine questions regarding re-admission, to clarify if readmission was within 21 days of discharge, and if the reason for re-admission was feeding related.
- Conditions
- Prematurity, Extreme Prematurity
- Being tested
- nfant(R) feeding system
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nfant(R) feeding systemDevice
Use of nfant(R) technology feeding system as an adjunct to visual assessment and cue-based feedings for infants born less than 30 weeks GA
| Study group | Role | What they receive |
|---|---|---|
| nfant(R) feeding system | Experimental | Addition of nfant(R) technology, along with visual assessments and cue-based feeding practices, to facilitate an infant's progression to full oral feeding and potentially improve developmentally supportive feeding practices. Receives: Device: nfant(R) feeding system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with decreased Feeding Related Length of Stay
Starts when an infant can take 5 ml of breast milk or formula orally with autonomic stability
Measured: up to 48 hours
Number of participants with Full oral feeding
Gestational age at which the infant first completes 90% of minimal ordered volumes without requiring gavage feeds for a 24 hour period
Measured: 33 weeks through study completion, an average of 1 year
Number of participants with hospital readmission for feeding related issues
Phone Follow-up
Measured: Within the first 21 days after Neonatal Intensive Care Unit discharge
Number of inpatient Modified Barium Swallow Study (MBSS)/repeat MBSS
Swallow Studies
Measured: Neonatal Intensive Care Unit admit through study completion, an average of 1 year
Number of participants with increased Sucking Efficiency
nfant(R) feeding metrics
Measured: 31 weeks GA through study completion, an average of 1 year
Number of participants with increased Sucking Amplitude
nfant(R) feeding metrics
Measured: 31 weeks GA through study completion, an average of 1 year
Number of participants with increased Sucking Frequency
nfant(R) feeding metrics
Measured: 31 weeks GA through study completion, an average of 1 year
Number of participants with increased Sucking Duration
nfant(R) feeding metrics
Measured: 31 weeks GA through study completion, an average of 1 year
Number of participants with increased Sucking Smoothness
nfant(R) feeding metrics
Measured: 31 weeks GA through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Jan 2020
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- Model description
- Prospective case matched controlled study (not a cohort). Enrolled infants will be matched with infants in the National Medical Index based on gestational age, gender, weight and comorbidities. A two cohort, mixed regression model would be used to correlate nfant® metrics to clinical outcomes.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's
- Sponsor type
- University, hospital or other
- Collaborators
- NFANT Labs
- Responsible party
- Sponsor
- Investigators
- Nanette Gremillion, PT, MS, CNT, Principal investigator, Woman's Hospital, Louisiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256889
- Sponsor's protocol ID
- RP-19-013
- Status last verified
- Mar 2024
- First submitted
- 21 Jan 2020
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nfant(R) Technology Feeding System As An Adjunct To Visual Assessment And Cue-Based Feedings For Infants Born Less Than 30 Weeks Gestational Age (GA)
- ClinicalTrials.gov ID
- NCT04256889
- Acronym / sponsor ID
- RP-19-013
- Conditions
- Prematurity, Extreme Prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Woman'sUniversity, hospital or other
- Collaborators
- NFANT Labs
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 5 Feb 2020 (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.
The purpose of the study is to utilize the objective data provided by the nfant® suite of products, along with current NICU visual assessment and cue-based feeding practices, in order to determine if feeding performance outcomes and clinical decision making for individualized feeding plans for premature infants born less than 30 weeks PMA are impacted.
Detailed description
Will obtain 5 official readings using the nfant(R) technology: baseline between 31 0/7 weeks and 32 0/7 weeks Post-Menstrual Age (PMA) with No Flow nipple, Cue-Based Feeding Readiness Reading with No Flow nipple no sooner than 33 0/7 weeks PMA, Post-Sequencing Reading with Extra Slow Flow nipple, Slow Flow nipple Reading, and Standard nipple Reading. The technology will also be utilized between readings 2 to 3 times a week. Phone Follow-up 2 question survey will be administered 21 days after discharge from Neonatal Intensive Care Unit.This survey entails routine questions regarding re-admission, to clarify if readmission was within 21 days of discharge, and if the reason for re-admission was feeding related.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective case matched controlled study (not a cohort). Enrolled infants will be matched with infants in the National Medical Index based on gestational age, gender, weight and comorbidities. A two cohort, mixed regression model would be used to correlate nfant® metrics to clinical outcomes.
| Arm | Type | Receives |
|---|---|---|
| nfant(R) feeding system | Experimental | Device: nfant(R) feeding systemAddition of nfant(R) technology, along with visual assessments and cue-based feeding practices, to facilitate an infant's progression to full oral feeding and potentially improve developmentally supportive feeding practices. |
Who may qualify
- Ages
- 22 to 29 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants less than or equal to 29 6/7 weeks gestation at birth
Key exclusion criteria (5 listed)
- Infants 30 weeks or greater gestation at birth
- Infants with known or suspected congenital anomalies or chromosomal abnormalities
- Infants with diagnoses known to interfere with oral feeding, including, but not limited to cleft lip. cleft palate, gastroschisis, Tracheoesophageal fistula, micrognathia.
- History of Intraventricular hemorrhage Grade 3 or 4 or Periventricular Leukomalacia
- Infants with known diagnoses known to interfere with Gastrointestinal absorption, including, but not limited to, Necrotizing Enterocolitis requiring surgical intervention
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 |
|---|---|---|
| nfant(R) feeding systemUse of nfant(R) technology feeding system as an adjunct to visual assessment and cue-based feedings for infants born less than 30 weeks GA | Device | nfant(R) feeding system |
Primary outcome
Number of participants with decreased Feeding Related Length of Stay
Time frame: up to 48 hours
Starts when an infant can take 5 ml of breast milk or formula orally with autonomic stability
Number of participants with Full oral feeding
Time frame: 33 weeks through study completion, an average of 1 year
Gestational age at which the infant first completes 90% of minimal ordered volumes without requiring gavage feeds for a 24 hour period
Number of participants with hospital readmission for feeding related issues
Time frame: Within the first 21 days after Neonatal Intensive Care Unit discharge
Phone Follow-up
Number of inpatient Modified Barium Swallow Study (MBSS)/repeat MBSS
Time frame: Neonatal Intensive Care Unit admit through study completion, an average of 1 year
Swallow Studies
Number of participants with increased Sucking Efficiency
Time frame: 31 weeks GA through study completion, an average of 1 year
nfant(R) feeding metrics
Number of participants with increased Sucking Amplitude
Time frame: 31 weeks GA through study completion, an average of 1 year
nfant(R) feeding metrics
Number of participants with increased Sucking Frequency
Time frame: 31 weeks GA through study completion, an average of 1 year
nfant(R) feeding metrics
Number of participants with increased Sucking Duration
Time frame: 31 weeks GA through study completion, an average of 1 year
nfant(R) feeding metrics
Number of participants with increased Sucking Smoothness
Time frame: 31 weeks GA through study completion, an average of 1 year
nfant(R) feeding metrics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Nanette Gremillion, PT, MS, CNT principal investigator
Woman's Hospital, Louisiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nfant(R) feeding system in people with Prematurity and Extreme Prematurity, run by Woman's 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 19 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with decreased Feeding Related Length of Stay (time frame: up to 48 hours). The study lists 9 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 19 Mar 2024.