Evaluating Patterned Oral Somatosensory Entrainment Stimulation Using the NTrainer on Oral Feeding Performance
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

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.
    

Detailed description: 
      One day prior to starting the study treatment, sucking strength and coordination will be
      measured on all enrolled infants using the NTrainer device in its "NeoSuck RT" assessment
      mode (See Appendix A). They will also be clinically assessed by an Infant Feeding Specialist
      using clinical assessment tools including the NOMAS and EFS (see Appendix B). After the
      assessment a feeding plan will be developed for use by the infant's bedside nurses. This
      feeding plan will include but not be limited to the use of techniques such as oromotor
      stimulation, side-lying, pacing, and slow flow nipples. After the clinical and NeoSuck
      assessments, infants will be randomized to receive either "Clinical" or "NTrainer"
      intervention. The intervention period will be 10 days.

      For study intervention feedings, the infant will undergo a brief exam of physiologic state,
      using the Oral Feeding Readiness Assessment portion of the EFS. If the infant is determined
      to be ready to feed (s)he infant will be cradled in a supportive inclined posture, swaddled,
      with limbs positioned at midline, and background/overhead lighting dimmed in the area. The
      infant will remain connected to the usual ICN monitors at all times for observation of
      respiration, heartbeat and oxygen saturation.

      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.

      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. Bottle feedings will be attempted at the other daily feedings by the
      bedside nurse using techniques suggested by the feeding plan. If 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.

      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.

      If the infant is able to successfully bottle feed the full prescribed volume for 5 of 8
      feedings per 24 hours, the study intervention will end.

      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. The assessment will include
      (1) a 3-minute measurement of sucking strength and coordination using "NeoSuck RT", and (2)
      two observational checklists (NOMAS and EFS) used to score infant feeding behaviors. The
      amount of oral feeding as a percentage of daily feeding volume will be recorded, as well as
      the number of feeding-associated apnea/bradycardia/oxygen desaturation events in the
      preceding 24 hours.

      The NTrainer recordings will be interpreted by researchers at the University of Kansas, but
      each baby's medical information will be kept confidential. The NTrainer study results will
      not become part WakeMed records. Each baby's study records will be available through the
      Neonatology division of WakeMed Faculty Physicians.
    

Observational model: Cohort
Time perspective: Prospective
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.