Length of Stay Clinical Trial
Official title:
Trial of Patterned Oral Somatosensory Entrainment
Verified date | May 2016 |
Source | KC BioMediX, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 210 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 26 Weeks to 31 Weeks |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center - Wakefield Hopsital | Bronx | New York |
United States | Montefiore Medical Center Weiler Hopsital | Bronx | New York |
United States | Cook Children's Medical Center | Fort Worth | Texas |
United States | North Central Baptist Hospital | San Antonio | Texas |
United States | Santa Clara Valleye Medical Center | San Jose | California |
Lead Sponsor | Collaborator |
---|---|
KC BioMediX, Inc | Innara Health, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The length of time to reach 100% full oral feeds | 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. | 14 days on average | No |
Secondary | The reduction in length of stay as a result of therapy | The difference in length of hospital stay (days) between experimental and control. | 24 days on average | No |
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