Pilot Study: The Effectiveness of VitalStim Therapy With Neonates

DESIGN:

  1. Randomized Study with a control group.  Double blind study.
  2. 15 patients in each group, 30 total.
  3.  All patients participating in the study will need a Modified Barium Swallow Study to assess pharyngeal swallowing skills.  Insurance should pay for this as all patients included will be demonstrating swallowing difficulties.
  4. All patients will receive “traditional” dysphagia therapy, experimental group will receive “traditional” therapy as well as VitalStim therapy.
  5. If after 2 weeks the baby has not made significant gains, the baby will receive known VitalStim therapy to help rule out need for long term supplemental feeding

CRITERIA:

In order to be placed in the study the patient must have at least one diagnosis on the diagnoses list and at least one symptom on the symptom list (that is noted over two therapeutic feedings).  A NOMAS (Neonatal Oral Motor Assessment Scale) score will be performed on each baby—control as well as therapeutic group.

Diagnoses:

  1. Grade III &/or Grade IV IVH (Intraventricular Hemorrhage)
  2. Hypoxic events/asphyxia prenatal or at birth
  3. BPD/CLD (Bronchopulmonary Dysplasia/Chronic Lung Disease)
  4. ANY neurological diagnosis/condition (excluding Encephalopathy)
  5. ANY baby with multiple intubations (greater than 2)
  6. ANY premature infant taking less than 25% of volumes by mouth by 35 weeks PCA.

Symptoms:

  1. Multiple swallowing episodes with desaturations/bradycardias
  2. Desaturations (less than 80%) with feeding
  3. Apnea spells with oral feeding
  4. Bradycardia (less than 80) with feeding
  5. Dysfunctional suck/swallow as noted by NOMAS
  6. Aspiration/Penetration

PROCEDURE:

A total of six VitalStim units will be used for this study.  Three units are disengaged and do not provide electrical stimulation, despite all outside appearances that the device is delivering current.  The amp indicator will raise and lower by the therapist’s control, however, current will not be delivered from the device.  Three other units will be working normally.  Serial numbers will be logged and kept by an outside department representative and will be put in a bag.  The units will then be pulled from the bag and numbered 1-6.  The number will be documented with the corresponding serial number for tracking purposes.  This information will be kept by the outside department and will not be given to the investigators until the study is completely over.  Patients will be assigned a unit 1-6 and will receive therapy only from the unit number designated to the patient.

Once babies are identified, an evaluation will be completed.  If the infant meets both the diagnoses and symptom requirements/criteria the baby will be placed in the study.  The infant will be placed on a list and given therapy with the VitalStim device with the next number that is available. Each baby will receive therapy two times a day, Monday-Friday, and one time a day Saturday and Sunday.  Treatment times will be 45 minutes to 1 hour in length. If the baby does not make significant gains to avoid a GTT/PEG (Gastrostomy Tube/Percutaneous Gastrostomy) in a two-week period, the baby will then receive known VitalStim therapy at that time.

DATA COLLECTION:

On each patient included in the study data will be collected information on the following:

  1. Time for safety of swallow in penetration and aspiration cases.
  2. Time for achievement of full oral feedings.
  3. Time for safe discharge from Developmental Team services and hospital stay.
  4. GTT/PEG or not.
  5. Any qualitative changes to the swallowing process.

We will be collecting additional data for ourselves and also following each patient in EDAC (Early Developmental Assessment Clinic) to ensure that results are long standing (control group as well as experimental group).

REASSESSMENT:

All babies will be reassessed at 2 weeks following initiation of treatment.  Percentage of required volumes will be noted, qualitative changes to the swallowing process will be evaluated and documented.  At this time, any baby who does not demonstrated significant gains will be given known VitalStim treatment before a decision for a GTT/PEG will be made.  This will allow babies in the control group to benefit from VitalStim prior to GTT/PEG placement.  If the baby is in the experimental group then additional time with the therapy process will be noted and evaluated to determine length of therapy for improvement in possible relation to diagnoses.  This will allow the double blind study to remain in effect throughout the study as well as to attempt to find a correlation with length of therapy to certain diagnoses.

Significant gain will be determined by:  at least a 50% improvement in volume taken by mouth as well as qualitative changes to the swallowing process as noted in bedside reassessment.  Qualitative changes would include: less multiple swallowing episodes per feeding (decrease by 50% of original episodes), no congestion or changes in vocal quality or respiratory patterns, less apnea and or bradycardias per feeding (decrease of at least 50% of original episodes).  A repeat Modified Barium Swallow Study will be performed only on infants who demonstrated aspiration and/or penetration on original Modified Barium Swallow Study. Our speech therapist in Cleveland Ohio is available to help with a variety of issues.