Oral Entrainment on Suck Development of Preterm Infants Born 23 to 34 Weeks Gestational Age (GA)
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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||November 2007|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
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 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01069744
|United States, Kansas|
|Overland Park Regional Medical Center|
|Overland Park, Kansas, United States, 66215|
|Principal Investigator:||Steven M Barlow, Ph.D.||University of Kansas|