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Oral Entrainment on Suck Development of Preterm Infants Born 23 to 34 Weeks Gestational Age (GA)

This study has been completed.
Sponsor:
Information provided by:
KC BioMediX, Inc
ClinicalTrials.gov Identifier:
NCT01069744
First received: February 15, 2010
Last updated: February 16, 2010
Last verified: February 2010
History of Changes
  Purpose

The development of sucking behaviors in preterm infants is thought to reflect neurobehavioral maturation and organization. From a clinical perspective, the ability to feed depends upon a coordinated sucking, swallowing and breathing pattern. In preterm infants less than 32 weeks gestation, this ability is not usually effective enough to sustain full oral feeds. In the interim, infants are fed by gavage tube until they are mature enough to take milk directly from the breast or bottle (Pinelli, Symington, 2005). Non-nutritive sucking has been used during gavage feeding and in the transition from gavage to breast/bottle feeding. The rationale for this intervention is that non-nutritive sucking facilitates the development of sucking behavior and improves digestion of enteral feeds.


Condition
Preterm Birth

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Randomized Control Trial Evaluating The Effect Of Patterned Oral Somatosensory Entrainment Stimulation Program (NTrainer System) On Suck Development and Feeding Performance of Preterm Infants Born Between 23 And 34 Weeks Gestational Age

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by KC BioMediX, Inc:

Primary Outcome Measures:
  • The Non-Nutritive Suck SpatioTemporal Index (NNS STI) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Transition-to-Oral Feed (TOF) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Length-of-Stay (LOS) in the NICU [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Growth velocity: Weight Gain (gms/kg/day) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Growth velocity: Head Growth (cm/wk) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Growth velocity: Length Growth (cm/wk) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: November 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control Group
Control group When neonates are considered ready for oral feedings these feedings will be started with the standard oral feeding protocol for the NICU but without the NTrainer stimulation regimen described previously.
NTrainer System
NTrainer Experimental Group When neonates are considered ready for oral feedings these feedings will be started simultaneously with the NTrainer therapy. Control and experimental interventions will not be initiated until the infant is in an optimal behavioral state, i.e., drowsy to quiet alert (NIDCAP state 3 or 4). Preterm infants in the experimental group will receive alternating 3-minute epochs of patterned oral somatosensory stimulation and null conditions using the NTrainer© during the tube (gavage) feeding session up to 4 times per day.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   23 Weeks to 34 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Preterm Infants Born Between 23 And 34 Weeks Gestational Age

Criteria

Inclusion Criteria:

  • Estational age between 23 weeks and 0/7 days and 34 weeks as per the best estimate by the neonatologist.
  • No major anomalies (chromosomal abnormalities, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, and multiple congenital anomalies)
  • Ready for oral feedings. Neonates who meet eligibility criteria (A-E) will be assessed by the health care team (neonatology and occupational therapist) with the NTrainer beginning at 32 weeks post menstrual age A. Hemodynamically stable and off all vasopressors B. Tolerating 120 ml/kg/day of enteral feedings C. Respiratory rate <80 breaths per minute D. Alert and active neurologic exam appropriate for post-menstrual age E. No signs of sepsis or intolerance of gastric feedings

Exclusion Criteria:

  • Gestational age < 23 weeks or > 34 weeks
  • Any major congenital anomalies
  • Not ready for oral feedings
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069744

Locations
United States, Kansas
Overland Park Regional Medical Center
Overland Park, Kansas, United States, 66215
Sponsors and Collaborators
KC BioMediX, Inc
Investigators
Principal Investigator: Steven M Barlow, Ph.D. University of Kansas
  More Information

No publications provided

Responsible Party: Steven M. Barlow, PhD, Professor, SPLH, Neuroscience, Human Biology, and Bioengineering,Communication Neuroscience Laboratories, Uninversity of Kansas
ClinicalTrials.gov Identifier: NCT01069744     History of Changes
Other Study ID Numbers: oprmc1
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 May 19, 2013