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| Name | Class |
|---|---|
| Innara Health, Inc. | INDUSTRY |
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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.
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:
Criteria for Exiting an Intervention Session:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTrainer® Intervention | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days on average |
| Measure | Description | Time Frame |
|---|---|---|
| The reduction in length of stay as a result of therapy | The difference in length of hospital stay (days) between experimental and control. | 24 days on average |
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Inclusion Criteria
- Birth Gestational age 26 0/6 - 30 6/7 weeks
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dongli Song, MD | Santa Clara Valley Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Clara Valleye Medical Center | San Jose | California | 95128 | United States | ||
| Montefiore Medical Center Weiler Hopsital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30817764 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Control Intervention | Device |
|
|
| The Bronx |
| New York |
| 10461 |
| United States |
| Montefiore Medical Center - Wakefield Hopsital | The Bronx | New York | 10466 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| North Central Baptist Hospital | San Antonio | Texas | 78258 | United States |
| D000091642 | Urogenital Diseases |