Status:
UNKNOWN
Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding
Lead Sponsor:
KC BioMediX, Inc
Collaborating Sponsors:
Innara Health, Inc.
Conditions:
Infant, Extremely Premature
Length of Stay
Eligibility:
All Genders
26-31 years
Phase:
NA
Brief Summary
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 (...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- \- Birth Gestational age 26 0/6 - 30 6/7 weeks
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01158391
Start Date
May 1 2010
End Date
June 1 2016
Last Update
May 18 2016
Active Locations (5)
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1
Santa Clara Valleye Medical Center
San Jose, California, United States, 95128
2
Montefiore Medical Center Weiler Hopsital
The Bronx, New York, United States, 10461
3
Montefiore Medical Center - Wakefield Hopsital
The Bronx, New York, United States, 10466
4
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104