Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding
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Purpose
The primary hypothesis is that the preterm infants (24 to 30 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 improved Non Nutritive Suck (NNS) parameters after completion of NTrainer System® training and improved growth at the time of full oral feeds and at the time of discharge.
| Condition | Intervention |
|---|---|
|
Premature Birth |
Device: NTrainer® Intervention |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Trial of Patterned Oral Somatosensory Entrainment |
- The length of time to reach 100% full oral feeds [ Time Frame: 14 days on average ] [ Designated as safety issue: No ]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. Decisions regarding oral feeding advancement will be made using the oral feeding advancement protocol
- The time to achieve the first successful oral feed [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]The time (days) from the initiation of the NTrainer System® training to first successful oral feed—without gavage supplementation.
- The degree of improvement in Non Nutritive Suck as a result of therapy. [ Time Frame: 14 days on average ] [ Designated as safety issue: No ]
Development and improvement of NNS parameters assessed by the NeoSuckRT® program
- Total oral compression
- NNS bursts
- NNS cycles
- NNS STI score
- The reduction in length of stay as a result of therapy [ Time Frame: 24 days on average ] [ Designated as safety issue: No ]The difference in length of hospital stay (days) between experimental and control.
| Estimated Enrollment: | 210 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Preterm Infants
NTrainer® Intervention' - Infants in the intervention for the experimental group will receive the NTrainer System patterned synthetic orocutaneous stimulation three to four times daily during the first 30 minutes of a tube (gavage) feeding session or 30 minutes before oral feeding for 10 days distributed over a two week period.
|
Device: NTrainer® Intervention
NTrainer® Intervention is a patterned synthetic orocutaneous stimulation will be delivered through a NICU (green) Soothie silicone pacifier or a NICU Wee Soothie® (purple). It is critical that each subject uses only one type of pacifier for the intervention. Infants in the experimental group will receive the NTrainer System patterned synthetic orocutaneous stimulation three to four times daily during the first 30 minutes of a tube (gavage) feeding session or 30 minutes before oral feeding for 10 days distributed over a two week period. Infants assigned to the control group will receive a sham stimulation program in which the infant will be offered the same type of NICU Soothie pacifier coupled to the receiver tube and handpiece, but not to the NTrainer System. Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 28 Weeks to 34 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Gestational age 24-32 weeks at birth, as determined by Dubowitz/Ballad examination and/or obstetric ultrasound done at less than 15 weeks.
- At least 28 weeks post menstrual age at the time of enrollment.
Exclusion Criteria:
- Chromosomal abnormalities, multiple congenital anomalies or any major congenital anomalies including craniofacial malformation, cyanotic congenital heart disease, gastroschisis, omphalocele, 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.
Contacts and Locations| United States, California | |
| Santa Clara Valleye Medical Center | Recruiting |
| San Jose, California, United States, 95128 | |
| Contact: Dongli Song, MD, PhD. 408-885-5420 dongli.song@hhs.sccgov.org | |
| Principal Investigator: Dongli Song, MS, PhD | |
| United States, Texas | |
| Cook Children's Medical Center | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Contact: Jonathan Nedrelow, MD 682-885-4283 jnedrelow@mac.com | |
| Principal Investigator: Jonathan Nedrelow, MD | |
| Sub-Investigator: Chandra Simpson, MD | |
| Principal Investigator: | Jonathan Nedrelow, MD | Pediatrix |
More Information
No publications provided
| Responsible Party: | KC BioMediX, Inc |
| ClinicalTrials.gov Identifier: | NCT01158391 History of Changes |
| Other Study ID Numbers: | KC_BMDX_002 |
| Study First Received: | June 24, 2010 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by KC BioMediX, Inc:
|
Premature Birth |
Additional relevant MeSH terms:
|
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
ClinicalTrials.gov processed this record on May 23, 2013