Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding
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.
|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.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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.
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|United States, California|
|Santa Clara Valleye Medical Center||Recruiting|
|San Jose, California, United States, 95128|
|Contact: Dongli Song, MD, PhD. 408-885-5420 firstname.lastname@example.org|
|Principal Investigator: Dongli Song, MS, PhD|
|United States, New York|
|Montefiore Medical Center Weiler Hopsital||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Suhas Nafday, MD 718-904-4105 SNAFDAY@montefiore.org|
|Principal Investigator: Suhas Nafday, MD|
|Montefiore Medical Center - Wakefield Hopsital||Recruiting|
|Bronx, New York, United States|
|Contact: Sheri Nemerofsky, MD 718-920-9551 SNEMEROF@montefiore.org|
|Principal Investigator: Suhas Nafday, MD|
|Sub-Investigator: Sheri Nemerofsky, MD|
|United States, Texas|
|Cook Children's Medical Center||Suspended|
|Fort Worth, Texas, United States, 76104|
|North Central Baptist Hospital||Recruiting|
|San Antonio, Texas, United States, 78258|
|Contact: Kaashif Ahmad, MD 210-575-4097 Kaashif_Ahmad@pediatrix.com|
|Principal Investigator: Kaashif Ahmad, MD|
|Sub-Investigator: Mary Wearden, MD|
|Principal Investigator:||Jonathan Nedrelow, MD||Pediatrix|