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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by KC BioMediX, Inc
Sponsor:
Collaborator:
Innara Health, Inc.
Information provided by (Responsible Party):
KC BioMediX, Inc
ClinicalTrials.gov Identifier:
NCT01158391
First received: June 24, 2010
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

The primary hypothesis is that the preterm infants (24 to 30 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 improved Non Nutritive Suck (NNS) parameters after completion of NTrainer System® training and improved growth at the time of full oral feeds and at the time of discharge.


Condition Intervention
Premature Birth
Device: NTrainer® Intervention

Study Type: Interventional
Study Design: 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. Decisions regarding oral feeding advancement will be made using the oral feeding advancement protocol


Secondary Outcome Measures:
  • The time to achieve the first successful oral feed [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]
    The time (days) from the initiation of the NTrainer System® training to first successful oral feed—without gavage supplementation.

  • The degree of improvement in Non Nutritive Suck as a result of therapy. [ Time Frame: 14 days on average ] [ Designated as safety issue: No ]

    Development and improvement of NNS parameters assessed by the NeoSuckRT® program

    1. Total oral compression
    2. NNS bursts
    3. NNS cycles
    4. NNS STI score

  • 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.


Estimated Enrollment: 210
Study Start Date: May 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preterm Infants
NTrainer® Intervention' - Infants in the intervention for the experimental group will receive the NTrainer System patterned synthetic orocutaneous stimulation three to four times daily during the first 30 minutes of a tube (gavage) feeding session or 30 minutes before oral feeding for 10 days distributed over a two week period.
Device: NTrainer® Intervention

NTrainer® Intervention is a patterned synthetic orocutaneous stimulation will be delivered through a NICU (green) Soothie silicone pacifier or a NICU Wee Soothie® (purple). It is critical that each subject uses only one type of pacifier for the intervention.

Infants in the experimental group will receive the NTrainer System patterned synthetic orocutaneous stimulation three to four times daily during the first 30 minutes of a tube (gavage) feeding session or 30 minutes before oral feeding for 10 days distributed over a two week period.

Infants assigned to the control group will receive a sham stimulation program in which the infant will be offered the same type of NICU Soothie pacifier coupled to the receiver tube and handpiece, but not to the NTrainer System.

Other Names:
  • KC BioMedix NTrainer
  • NTrainer System
  • Actifier

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   28 Weeks to 34 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gestational age 24-32 weeks at birth, as determined by Dubowitz/Ballad examination and/or obstetric ultrasound done at less than 15 weeks.
  • At least 28 weeks post menstrual age at the time of enrollment.

Exclusion Criteria:

  • Chromosomal abnormalities, multiple congenital anomalies or any major congenital anomalies including 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.
  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 Recruiting
San Jose, California, United States, 95128
Contact: Dongli Song, MD, PhD.    408-885-5420    dongli.song@hhs.sccgov.org   
Principal Investigator: Dongli Song, MS, PhD         
United States, New York
Montefiore Medical Center - Wakefield Hopsital Recruiting
Bronx, New York, United States
Contact: Sheri Nemerofsky, MD    718-920-9551    SNEMEROF@montefiore.org   
Principal Investigator: Suhas Nafday, MD         
Sub-Investigator: Sheri Nemerofsky, MD         
Montefiore Medical Center Weiler Hopsital Recruiting
Bronx, New York, United States, 10461
Contact: Suhas Nafday, MD    718-904-4105    SNAFDAY@montefiore.org   
Principal Investigator: Suhas Nafday, MD         
United States, Texas
Cook Children's Medical Center Suspended
Fort Worth, Texas, United States, 76104
North Central Baptist Hospital Recruiting
San Antonio, Texas, United States, 78258
Contact: Kaashif Ahmad, MD    210-575-4097    Kaashif_Ahmad@pediatrix.com   
Principal Investigator: Kaashif Ahmad, MD         
Sub-Investigator: Mary Wearden, MD         
Sponsors and Collaborators
KC BioMediX, Inc
Innara Health, Inc.
Investigators
Principal Investigator: Jonathan Nedrelow, MD Pediatrix
  More Information

No publications provided

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: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by KC BioMediX, Inc:
Premature Birth

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

ClinicalTrials.gov processed this record on November 20, 2014