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

NCT01069744 | Completed

• 1 other identifier: oprmc1
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (3)

• The Non-Nutritive Suck SpatioTemporal Index (NNS STI)

  28 days

• Transition-to-Oral Feed (TOF)

  28 days

• Length-of-Stay (LOS) in the NICU

  28 days

Secondary Outcomes (3)

• Growth velocity: Weight Gain (gms/kg/day)

  28 days

• Growth velocity: Head Growth (cm/wk)

  28 days

• Growth velocity: Length Growth (cm/wk)

  28 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 23 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm Infants Born Between 23 And 34 Weeks Gestational Age

You may qualify if:

• 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

You may not qualify if:

• Gestational age \< 23 weeks or \> 34 weeks
• Any major congenital anomalies
• Not ready for oral feedings

Sponsors & Collaborators

• KC BioMediX, Inc: lead

Study Sites (1)

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

Location

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

• Steven M Barlow, Ph.D.

  University of Kansas

  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: November 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 17, 2010

Record last verified: 2010-02

Locations

US (1)