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

May 17, 2016 updated by: KC BioMediX, Inc

Trial of Patterned Oral Somatosensory Entrainment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 each training session the infant will be evaluated for the following criteria:

Criteria for Initiation of each intervention:

  1. Not on continuous vasopressor medications
  2. Feeding in previous 48 hours.
  3. Not mechanically ventilated. If the infant is on CPAP or Nasal cannula >2 liters per minute, then the FiO2 must be <40%.

Criteria for Exiting an Intervention Session:

  1. If during an intervention the baby experiences Apnea/Bradycardic/Desaturation events requiring nursing stimulation or intervention during the training--hold future interventions for one session.
  2. If the interventions are held for 3 consecutive sessions, hold interventions for a full day (24 hours).
  3. If interventions are held for 3 days (72 hours) and if GA is <32 weeks when ready to restart therapy sessions, then complete another 10 days of interventions.
  4. If interventions are held for 3 days (72 hours) and if GA is >32 weeks when ready to restart therapy, then complete the remaining N interventions sessions for a total of 10 days of therapy.
  5. If interventions are held for 3 days (72 hours) and the infant is on full oral feeds when ready to restart therapy interventions then discontinue any remaining interventions sessions.

The Interventions

Infants in the Treatment and Control group will receive orocutaneous stimulation up to four times daily during the first 30 minutes of a tube (gavage) feeding session to achieve an average of 30 therapy sessions distributed over a two week period.

Infants assigned to the either group will be offered the pacifier by gently placing the pacifier on the lips. The pacifier should not be forced into the mouth and should not be moved in any manner that would represent any form of patterned input such as moving the pacifier in and out, tapping on the lips or face or massaging the mouth or oral facial structure.

All other preparatory, infant positioning, and sampling conditions will be equal among groups. The healthcare team will continue to promote feeding and growth at the standard of care for babies in both groups.

Treatment Group

Infants in the Treatment group will receive the NTrainer System® patterned synthetic orocutaneous stimulation. A single NTrainer intervention runs for 20 minutes and involves three 3 minute sessions during which the pacifier pulses. The pulsing sessions are separated by 5.5 min breaks where the pacifier is quiet.

Control Group

Infants assigned to the control group will receive an orocutaneous intervention in which the infant will be offered a 20 minute non-nutritive sucking opportunity with a 'quiet' pacifier.

Breast Feeding Non-nutritive breastfeeding and nutritive breastfeeding practice will not be altered or changed by the interventions. The availability of the mother will be taken into consideration for the scheduling of any intervention sessions and no study intervention will interfere with breastfeeding behavior.

Safety To help ensure the safety of the study participants the heart rate, oxygen saturation, and blood pressure will be monitored throughout the therapy session.

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95128
        • Santa Clara Valleye Medical Center
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center Weiler Hopsital
      • Bronx, New York, United States, 10466
        • Montefiore Medical Center - Wakefield Hopsital
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center
      • San Antonio, Texas, United States, 78258
        • North Central Baptist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The length of time to reach 100% full oral feeds
Time Frame: 14 days on average
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The reduction in length of stay as a result of therapy
Time Frame: 24 days on average
The difference in length of hospital stay (days) between experimental and control.
24 days on average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KC BioMediX, Inc

Collaborators

Innara Health, Inc.

Investigators

  • Principal Investigator: Dongli Song, MD, Santa Clara Valley Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

June 24, 2010

First Submitted That Met QC Criteria

July 6, 2010

First Posted (Estimate)

July 8, 2010

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC_BMDX_002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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