Evaluating Patterned Oral Somatosensory Entrainment Stimulation Using the NTrainer on Oral Feeding Performance

February 16, 2010 updated by: KC BioMediX, Inc

Evaluating the Effect of Patterned Oral Somatosensory Entrainment Stimulation Using the NTrainer on Oral Feeding Performance in Infants With Feeding Dysfunction

This is a research study to determine if an experimental device called the NTrainer can improve oral feeding skills more quickly and more effectively than traditional methods in infants who are at high risk of feeding dysfunction and delayed hospital discharge.

Study Overview

Status

Completed

Conditions

Detailed Description

One day prior to starting the study treatment, sucking strength and coordination will be measured on all enrolled infants using the NTrainer device in its "NeoSuck RT" assessment mode (See Appendix A). They will also be clinically assessed by an Infant Feeding Specialist using clinical assessment tools including the NOMAS and EFS (see Appendix B). After the assessment a feeding plan will be developed for use by the infant's bedside nurses. This feeding plan will include but not be limited to the use of techniques such as oromotor stimulation, side-lying, pacing, and slow flow nipples. After the clinical and NeoSuck assessments, infants will be randomized to receive either "Clinical" or "NTrainer" intervention. The intervention period will be 10 days.

For study intervention feedings, the infant will undergo a brief exam of physiologic state, using the Oral Feeding Readiness Assessment portion of the EFS. If the infant is determined to be ready to feed (s)he infant will be cradled in a supportive inclined posture, swaddled, with limbs positioned at midline, and background/overhead lighting dimmed in the area. The infant will remain connected to the usual ICN monitors at all times for observation of respiration, heartbeat and oxygen saturation.

In the Clinical group bottle feedings will be attempted by the bedside nurses, using techniques suggested in the feeding plan. The Infant Feeding Specialist will observe at least one feeding per day to assure that the feeding plan is being adhered to. If, in the judgment of the person feeding the infant, the infant is unable to complete the bottle feeding, the remaining volume will be given via an indwelling gavage tube. During all gavage feedings, both total and partial, infants will be offered a pacifier to suck on.

In the NTrainer group, three feedings per day will be given via gavage tube while the infant is receiving NTrainer stimulation. The stimulation will be done by alternating 3 minute epochs of NTrainer stimulation with 3 minutes of sucking on a regular pacifier, up to a total time of 30 minutes. Bottle feedings will be attempted at the other daily feedings by the bedside nurse using techniques suggested by the feeding plan. If the infant is unable to complete the bottle feeding, the remaining volume will be given via an indwelling gavage tube. During all gavage feedings, both total and partial, infants will be offered a pacifier to suck on.

Every other day, 15 minutes prior to a feeding that is not one of the study sessions, each infant's suck strength and coordination will be measured using the NTrainer device in its "NeoSuck RT" Assessment mode.

If the infant is able to successfully bottle feed the full prescribed volume for 5 of 8 feedings per 24 hours, the study intervention will end.

On the day after the study intervention period is completed each infant will be assessed by an investigator unaware of the infant's study group assignment. The assessment will include (1) a 3-minute measurement of sucking strength and coordination using "NeoSuck RT", and (2) two observational checklists (NOMAS and EFS) used to score infant feeding behaviors. The amount of oral feeding as a percentage of daily feeding volume will be recorded, as well as the number of feeding-associated apnea/bradycardia/oxygen desaturation events in the preceding 24 hours.

The NTrainer recordings will be interpreted by researchers at the University of Kansas, but each baby's medical information will be kept confidential. The NTrainer study results will not become part WakeMed records. Each baby's study records will be available through the Neonatology division of WakeMed Faculty Physicians.

Study Type

Observational

Enrollment (Actual)

24

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
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • WakeMed

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

7 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Infants born prematurely may suffer multiple adverse events in the Intensive Care Nursery, and these experiences may negatively impact normal developmental processes of immature cardiorespiratory, gastrointestinal and central nervous systems. As a result, many infants have at least transient difficulties learning to successfully manage oral feedings. Oral feeding difficulties in the ICN may prolong the time to discharge, cause significant parental anxiety, and persist throughout infancy. Indeed, as many as 40% of patients followed in feeding disorder clinics are former preterm infants.

Description

Inclusion Criteria:

  • 34 weeks postmenstrual age, medically stable enough to attempt bottle feedings
  • Born at 28 completed weeks of gestation or less and are still on oxygen at 34 weeks postmenstrual age, or (2) have had intestinal surgery, or (3) have had recurrent episodes of feeding intolerance, or (4) have a significant intracranial hemorrhage or periventricular leukomalacia.

Exclusion Criteria:

  • Infants will be excluded if their mothers plan to exclusively breastfeed their infant after discharge home.

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

Cohorts and Interventions

Group / Cohort
Clinical Group
In the Clinical group bottle feedings will be attempted by the bedside nurses, using techniques suggested in the feeding plan. The Infant Feeding Specialist will observe at least one feeding per day to assure that the feeding plan is being adhered to. If, in the judgment of the person feeding the infant, the infant is unable to complete the bottle feeding, the remaining volume will be given via an indwelling gavage tube. During all gavage feedings, both total and partial, infants will be offered a pacifier to suck on.
NTrainer Group

In the NTrainer group, three feedings per day will be given via gavage tube while the infant is receiving NTrainer stimulation. The stimulation will be done by alternating 3 minute epochs of NTrainer stimulation with 3 minutes of sucking on a regular pacifier, up to a total time of 30 minutes.

Every other day, 15 minutes prior to a feeding that is not one of the study sessions, each infant's suck strength and coordination will be measured using the NTrainer device in its "NeoSuck RT" Assessment mode.

On the day after the study intervention period is completed each infant will be assessed by an investigator unaware of the infant's study group assignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postmenstrual age at the time of full oral feedings
Time Frame: At the time of full oral feedings
At the time of full oral feedings
Postmenstrual age at the time of hospital discharge
Time Frame: At discharge
At discharge

Collaborators and Investigators

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

Sponsor

KC BioMediX, Inc

Investigators

  • Principal Investigator: Thomas Young, MD, Wake Med Faculty Physician

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

Helpful Links

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

March 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

February 15, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

February 17, 2010

Last Update Submitted That Met QC Criteria

February 16, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WakeMEd Study 751

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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