Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding
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|ClinicalTrials.gov Identifier: NCT01158391|
Recruitment Status : Unknown
Verified May 2016 by KC BioMediX, Inc.
Recruitment status was: Active, not recruiting
First Posted : July 8, 2010
Last Update Posted : May 18, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Infant, Extremely Premature Length of Stay Feeding||Device: NTrainer® Intervention Device: Control Intervention||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial of Patterned Oral Somatosensory Entrainment|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
Experimental: NTrainer® Intervention
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.
Device: NTrainer® Intervention
Sham Comparator: Control Intervention
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.
Device: Control Intervention
- 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.
- The reduction in length of stay as a result of therapy [ Time Frame: 24 days on average ]The difference in length of hospital stay (days) between experimental and control.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158391
|United States, California|
|Santa Clara Valleye Medical Center|
|San Jose, California, United States, 95128|
|United States, New York|
|Montefiore Medical Center Weiler Hopsital|
|Bronx, New York, United States, 10461|
|Montefiore Medical Center - Wakefield Hopsital|
|Bronx, New York, United States, 10466|
|United States, Texas|
|Cook Children's Medical Center|
|Fort Worth, Texas, United States, 76104|
|North Central Baptist Hospital|
|San Antonio, Texas, United States, 78258|
|Principal Investigator:||Dongli Song, MD||Santa Clara Valley Medical Center|