Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Innara Health, Inc.
Information provided by (Responsible Party):
KC BioMediX, Inc
ClinicalTrials.gov Identifier:
NCT01158391
First received: June 24, 2010
Last updated: May 17, 2016
Last verified: May 2016
  Purpose

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 Intervention
Infant, Extremely Premature
Length of Stay
Feeding
Device: NTrainer® Intervention
Device: Control Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial of Patterned Oral Somatosensory Entrainment

Further study details as provided by KC BioMediX, Inc:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 210
Study Start Date: May 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • KC BioMedix NTrainer
  • NTrainer System
  • Actifier
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
Other Names:
  • Non-nutritive Sucking
  • NNS Opportunity

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   26 Weeks to 31 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158391

Locations
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
Sponsors and Collaborators
KC BioMediX, Inc
Innara Health, Inc.
Investigators
Principal Investigator: Dongli Song, MD Santa Clara Valley Medical Center
  More Information

Responsible Party: KC BioMediX, Inc
ClinicalTrials.gov Identifier: NCT01158391     History of Changes
Other Study ID Numbers: KC_BMDX_002 
Study First Received: June 24, 2010
Last Updated: May 17, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by KC BioMediX, Inc:
Premature Birth

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 28, 2016