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

This study has been completed.
Sponsor:
Information provided by:
KC BioMediX, Inc
ClinicalTrials.gov Identifier:
NCT01069718
First received: February 15, 2010
Last updated: February 16, 2010
Last verified: February 2010
  Purpose

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.


Condition
Preterm Birth

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Effect of Patterned Oral Somatosensory Entrainment Stimulation Using the NTrainer on Oral Feeding Performance in Infants With Feeding Dysfunction

Further study details as provided by KC BioMediX, Inc:

Primary Outcome Measures:
  • Postmenstrual age at the time of full oral feedings [ Time Frame: At the time of full oral feedings ] [ Designated as safety issue: No ]
  • Postmenstrual age at the time of hospital discharge [ Time Frame: At discharge ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2008
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


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.

  Eligibility

Ages Eligible for Study:   34 Weeks to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  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: NCT01069718

Locations
United States, North Carolina
WakeMed
Raleigh, North Carolina, United States, 27610
Sponsors and Collaborators
KC BioMediX, Inc
Investigators
Principal Investigator: Thomas Young, MD Wake Med Faculty Physician
  More Information

Additional Information:
Publications:
Responsible Party: Thomas Young, MD, WakeMed Faculty Physician
ClinicalTrials.gov Identifier: NCT01069718     History of Changes
Other Study ID Numbers: WakeMEd Study 751
Study First Received: February 15, 2010
Last Updated: February 16, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014