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

NCT01069718 | Completed

• 1 other identifier: WakeMEd Study 751
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (2)

• Postmenstrual age at the time of full oral feedings

  At the time of full oral feedings

• Postmenstrual age at the time of hospital discharge

  At discharge

Study Arms (2)

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.

Eligibility Criteria

• Age: 34 Weeks - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• KC BioMediX, Inc: lead

Study Sites (1)

WakeMed

Raleigh, North Carolina, 27610, United States

Location

Related Publications (1)

• 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.

  PMID: 18548084 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Thomas Young, MD

  Wake Med Faculty Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 15, 2010
• First Posted: February 17, 2010
• Study Start: March 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 17, 2010

Record last verified: 2010-02

Locations

US (1)