Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding
Status unconfirmed · Not applicable
Conditions studied: Infant, Extremely Premature, Length of Stay, Feeding
In brief
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.
Key facts
- Study ID
- NCT01158391
- Run by
- KC BioMediX, Inc
- People needed
- 210
- Starts
- 2010-05-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2016-05-18
Who can join
Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Birth Gestational age 26 0/6 - 30 6/7 weeks
You may not qualify if…
- Chromosomal abnormalities
- Congenital anomalies included but not limited to
- 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
- Infants with narcotic abstinence syndrome (NAS)
- Infants enrolled in another clinical study
Where it is running
- Santa Clara Valleye Medical Center — San Jose, California, United States
- Montefiore Medical Center Weiler Hopsital — The Bronx, New York, United States
- Montefiore Medical Center - Wakefield Hopsital — The Bronx, New York, United States
- Cook Children's Medical Center — Fort Worth, Texas, United States
- North Central Baptist Hospital — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.