Infant, Extremely PrematureNCT01158391
Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding
A study testing NTrainer® Intervention in people with Infant, Extremely Premature and Length of Stay, run by KC BioMediX, Inc at 5 sites in United States.
Trial summary
The primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age) who undergo the NTrainer System® training will transition to full oral feeds faster than the control group (i.e. the study group will be superior to the control). Read more about this study
- Who is it for?
- Ages 26 to 31 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant, Extremely Premature, Length of Stay, Feeding
- What is being tested?
- NTrainer® Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2010to Jun 2016
- 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 26 to 31 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birth Gestational age 26 0/6 - 30 6/7 weeks
Who cannot join
- Chromosomal abnormalities
- Congenital anomalies included but not limited to
- craniofacial malformation
- cyanotic congenital heart disease
- gastroschisis
- omphalocele
Show all 15Show fewer
- diaphragmatic hernia or other major gastrointestinal anomalies
- Major neurological anomaly
- Infants with history of surgical necrotizing enterocolitis (stage III)
- Infants with vocal cord paralysis
- Infants with neonatal seizures
- Infants with meningitis at time of enrollment
- Infants who are nippling all feeds at the time of enrollment
- Infants with narcotic abstinence syndrome (NAS)
- Infants enrolled in another clinical study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cook Children's Medical Center
Fort Worth, Texas, 76104
North Central Baptist Hospital
San Antonio, Texas, 78258
Santa Clara Valleye Medical Center
San Jose, California, 95128
Montefiore Medical Center Weiler Hopsital
The Bronx, New York, 10461
Montefiore Medical Center - Wakefield Hopsital
The Bronx, New York, 10466
About this study
Official title: Trial of Patterned Oral Somatosensory Entrainment
The primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age) who undergo the NTrainer System® training will transition to full oral feeds faster than the control group (i.e. the study group will be superior to the control).
The secondary hypothesis is that the infants in the NTrainer System® experimental group will have shorter lengths of stay.
Read the detailed description
Patterned Oral Somatosensory Intervention
The interventions (Treatment vs Control) will be initiated simultaneously with tube (gavage) feeds as early as 30 weeks post-menstrual age. Before and during each training session the infant will be evaluated for the following criteria:
Criteria for Initiation of each intervention:
- Not on continuous vasopressor medications
- Feeding in previous 48 hours.
- Not mechanically ventilated. If the infant is on CPAP or Nasal cannula >2 liters per minute, then the FiO2 must be <40%.
Criteria for Exiting an Intervention Session:
- If during an intervention the baby experiences Apnea/Bradycardic/Desaturation events requiring nursing stimulation or intervention during the training--hold future interventions for one session.
- If the interventions are held for 3 consecutive sessions, hold interventions for a full day (24 hours).
- If interventions are held for 3 days (72 hours) and if GA is <32 weeks when ready to restart therapy sessions, then complete another 10 days of interventions.
- If interventions are held for 3 days (72 hours) and if GA is >32 weeks when ready to restart therapy, then complete the remaining N interventions sessions for a total of 10 days of therapy.
- If interventions are held for 3 days (72 hours) and the infant is on full oral feeds when ready to restart therapy interventions then discontinue any remaining interventions sessions.
The Interventions
Infants in the Treatment and Control group will receive orocutaneous stimulation up to four times daily during the first 30 minutes of a tube (gavage) feeding session to achieve an average of 30 therapy sessions distributed over a two week period.
Infants assigned to the either group will be offered the pacifier by gently placing the pacifier on the lips. The pacifier should not be forced into the mouth and should not be moved in any manner that would represent any form of patterned input such as moving the pacifier in and out, tapping on the lips or face or massaging the mouth or oral facial structure.
All other preparatory, infant positioning, and sampling conditions will be equal among groups. The healthcare team will continue to promote feeding and growth at the standard of care for babies in both groups.
Treatment Group
Infants in the Treatment group will receive the NTrainer System® patterned synthetic orocutaneous stimulation. A single NTrainer intervention runs for 20 minutes and involves three 3 minute sessions during which the pacifier pulses. The pulsing sessions are separated by 5.5 min breaks where the pacifier is quiet.
Control Group
Infants assigned to the control group will receive an orocutaneous intervention in which the infant will be offered a 20 minute non-nutritive sucking opportunity with a 'quiet' pacifier.
Breast Feeding Non-nutritive breastfeeding and nutritive breastfeeding practice will not be altered or changed by the interventions. The availability of the mother will be taken into consideration for the scheduling of any intervention sessions and no study intervention will interfere with breastfeeding behavior.
Safety To help ensure the safety of the study participants the heart rate, oxygen saturation, and blood pressure will be monitored throughout the therapy session.
- Conditions
- Infant, Extremely Premature, Length of Stay, Feeding
- Being tested
- NTrainer® Intervention, Control Intervention
- Keywords
- Premature Birth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTrainer® InterventionDevice
Also called KC BioMedix NTrainer, NTrainer System, Actifier
Control InterventionDevice
Also called Non-nutritive Sucking, NNS Opportunity
| Study group | Role | What they receive |
|---|---|---|
| NTrainer® Intervention | Experimental | NTrainer® Intervention - Infants in the experimental group will receive the NTrainer System patterned synthetic orocutaneous stimulation during the first 30 minutes of a tube (gavage) feeding session. The intervention may be provided up to 4 times daily to achieve an average of 30 sessions distributed over a two week period. Receives: Device: NTrainer® Intervention |
| Control Intervention | Sham comparator | Control Intervention - Infants in the Control group will be provided orocutaneous stimulation with a 'quiet pacifier' during the first 30 minutes of a tube (gavage) feeding session. The intervention may be provided up to 4 times daily to achieve an average of 30 sessions distributed over a two week period. Receives: Device: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of time to reach 100% full oral feeds
Time (in days) from initiation of oral feedings to the first oral intake that results in 100% oral feeding (definition of 100% oral feeding: no gavage supplementation and taking at least 120 milliliters per kilogram per day for 48 consecutive hours of breast milk, fortified breast milk or preterm formula as ordered by the child's physician.
Measured: 14 days on average
Secondary outcomes (1)
The reduction in length of stay as a result of therapy
The difference in length of hospital stay (days) between experimental and control.
Measured: 24 days on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, Extremely PrematureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- KC BioMediX, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innara Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Dongli Song, MD, Principal investigator, Santa Clara Valley Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158391
- Sponsor's protocol ID
- KC_BMDX_002
- Status last verified
- May 2016
- First submitted
- 24 Jun 2010
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Song D, Jegatheesan P, Nafday S, Ahmad KA, Nedrelow J, Wearden M, Nemerofsky S, Pooley S, Thompson D, Vail D, Cornejo T, Cohen Z, Govindaswami B. Patterned frequency-modulated oral stimulation in preterm infants: A multicenter randomized controlled trial. PLoS One. 2019 Feb 28;14(2):e0212675. doi: 10.1371/journal.pone.0212675. eCollection 2019.
PubMed 30817764
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Patterned Oral Somatosensory Entrainment
- ClinicalTrials.gov ID
- NCT01158391
- Acronym / sponsor ID
- KC_BMDX_002
- Conditions
- Infant, Extremely Premature, Length of Stay, Feeding
- Keywords
- Premature Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (actual)
- Lead sponsor
- KC BioMediX, IncIndustry (pharma, biotech, devices)
- Collaborators
- Innara Health, Inc.
- Study start
- May 2010
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 8 Jul 2010 (estimated)
- 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 primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age) who undergo the NTrainer System® training will transition to full oral feeds faster than the control group (i.e. the study group will be superior to the control).
The secondary hypothesis is that the infants in the NTrainer System® experimental group will have shorter lengths of stay.
Detailed description
Patterned Oral Somatosensory Intervention
The interventions (Treatment vs Control) will be initiated simultaneously with tube (gavage) feeds as early as 30 weeks post-menstrual age. Before and during each training session the infant will be evaluated for the following criteria:
Criteria for Initiation of each intervention:
- Not on continuous vasopressor medications
- Feeding in previous 48 hours.
- Not mechanically ventilated. If the infant is on CPAP or Nasal cannula >2 liters per minute, then the FiO2 must be <40%.
Criteria for Exiting an Intervention Session:
- If during an intervention the baby experiences Apnea/Bradycardic/Desaturation events requiring nursing stimulation or intervention during the training--hold future interventions for one session.
- If the interventions are held for 3 consecutive sessions, hold interventions for a full day (24 hours).
- If interventions are held for 3 days (72 hours) and if GA is <32 weeks when ready to restart therapy sessions, then complete another 10 days of interventions.
- If interventions are held for 3 days (72 hours) and if GA is >32 weeks when ready to restart therapy, then complete the remaining N interventions sessions for a total of 10 days of therapy.
- If interventions are held for 3 days (72 hours) and the infant is on full oral feeds when ready to restart therapy interventions then discontinue any remaining interventions sessions.
The Interventions
Infants in the Treatment and Control group will receive orocutaneous stimulation up to four times daily during the first 30 minutes of a tube (gavage) feeding session to achieve an average of 30 therapy sessions distributed over a two week period.
Infants assigned to the either group will be offered the pacifier by gently placing the pacifier on the lips. The pacifier should not be forced into the mouth and should not be moved in any manner that would represent any form of patterned input such as moving the pacifier in and out, tapping on the lips or face or massaging the mouth or oral facial structure.
All other preparatory, infant positioning, and sampling conditions will be equal among groups. The healthcare team will continue to promote feeding and growth at the standard of care for babies in both groups.
Treatment Group
Infants in the Treatment group will receive the NTrainer System® patterned synthetic orocutaneous stimulation. A single NTrainer intervention runs for 20 minutes and involves three 3 minute sessions during which the pacifier pulses. The pulsing sessions are separated by 5.5 min breaks where the pacifier is quiet.
Control Group
Infants assigned to the control group will receive an orocutaneous intervention in which the infant will be offered a 20 minute non-nutritive sucking opportunity with a 'quiet' pacifier.
Breast Feeding Non-nutritive breastfeeding and nutritive breastfeeding practice will not be altered or changed by the interventions. The availability of the mother will be taken into consideration for the scheduling of any intervention sessions and no study intervention will interfere with breastfeeding behavior.
Safety To help ensure the safety of the study participants the heart rate, oxygen saturation, and blood pressure will be monitored throughout the therapy session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTrainer® Intervention | Experimental | Device: NTrainer® InterventionNTrainer® Intervention - Infants in the experimental group will receive the NTrainer System patterned synthetic orocutaneous stimulation during the first 30 minutes of a tube (gavage) feeding session. The intervention may be provided up to 4 times daily to achieve an average of 30 sessions distributed over a two week period. |
| Control Intervention | Sham comparator | Device: Control InterventionControl Intervention - Infants in the Control group will be provided orocutaneous stimulation with a 'quiet pacifier' during the first 30 minutes of a tube (gavage) feeding session. The intervention may be provided up to 4 times daily to achieve an average of 30 sessions distributed over a two week period. |
Who may qualify
- Ages
- 26 to 31 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Birth Gestational age 26 0/6 - 30 6/7 weeks
Key exclusion criteria (15 listed)
- Chromosomal abnormalities
- Congenital anomalies included but not limited to
- craniofacial malformation
- cyanotic congenital heart disease
- gastroschisis
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 |
|---|---|---|
| NTrainer® InterventionAlso: KC BioMedix NTrainer, NTrainer System, Actifier | Device | NTrainer® Intervention |
| Control InterventionAlso: Non-nutritive Sucking, NNS Opportunity | Device | Control Intervention |
Primary outcome
The length of time to reach 100% full oral feeds
Time frame: 14 days on average
Time (in days) from initiation of oral feedings to the first oral intake that results in 100% oral feeding (definition of 100% oral feeding: no gavage supplementation and taking at least 120 milliliters per kilogram per day for 48 consecutive hours of breast milk, fortified breast milk or preterm formula as ordered by the child's physician.
1 secondary outcome
The reduction in length of stay as a result of therapy
Time frame: 24 days on average
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Derived from this study: PubMed 30817764Song D, Jegatheesan P, Nafday S, Ahmad KA, Nedrelow J, Wearden M, Nemerofsky S, Pooley S, Thompson D, Vail D, Cornejo T, Cohen Z, Govindaswami B. Patterned frequency-modulated oral stimulation in preterm infants: A multicenter randomized controlled trial. PLoS One. 2019 Feb 28;14(2):e0212675. doi: 10.1371/journal.pone.0212675. eCollection 2019.
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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.
Dongli Song, MD principal investigator
Santa Clara Valley Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NTrainer® Intervention in people with Infant, Extremely Premature and Length of Stay, run by KC BioMediX, Inc at 5 sites 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 15 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 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?
The length of time to reach 100% full oral feeds (time frame: 14 days on average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01158391, which also lists 1 linked publication.
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 18 May 2016.