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

NCT ID: NCT01069718

Last Updated: 2010-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-11-30

Brief Summary

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.

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.

Conditions

Preterm Birth

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 34 Weeks
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KC BioMediX, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

WakeMed Faculty Physician

Principal Investigators

Thomas Young, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Med Faculty Physician

Locations

WakeMed

Raleigh, North Carolina, United States

Countries

United States

References

Barlow SM, Finan DS, Lee J, Chu S. Synthetic orocutaneous stimulation entrains preterm infants with feeding difficulties to suck. J Perinatol. 2008 Aug;28(8):541-8. doi: 10.1038/jp.2008.57. Epub 2008 Jun 12.

Reference Type: BACKGROUND

PMID: 18548084 (View on PubMed)

Other Identifiers

WakeMEd Study 751

Identifier Type: -

Identifier Source: org_study_id