We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069744
First Posted: February 17, 2010
Last Update Posted: February 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
KC BioMediX, Inc
  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

Further study details as provided by KC BioMediX, Inc:

Primary Outcome Measures:
  • The Non-Nutritive Suck SpatioTemporal Index (NNS STI) [ Time Frame: 28 days ]
  • Transition-to-Oral Feed (TOF) [ Time Frame: 28 days ]
  • Length-of-Stay (LOS) in the NICU [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • Growth velocity: Weight Gain (gms/kg/day) [ Time Frame: 28 days ]
  • Growth velocity: Head Growth (cm/wk) [ Time Frame: 28 days ]
  • Growth velocity: Length Growth (cm/wk) [ Time Frame: 28 days ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   23 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 15, 2010
First Posted: February 17, 2010
Last Update Posted: February 17, 2010
Last Verified: February 2010

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


To Top