Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding

Patterned Oral Somatosensory Intervention

The interventions (Treatment vs Control) will be initiated simultaneously with tube (gavage)
feeds as early as 30 weeks post-menstrual age. Before and during each training session the
infant will be evaluated for the following criteria:

Criteria for Initiation of each intervention:

1. Not on continuous vasopressor medications

2. Feeding in previous 48 hours.

3. Not mechanically ventilated. If the infant is on CPAP or Nasal cannula >2 liters per
minute, then the FiO2 must be <40%.

Criteria for Exiting an Intervention Session:

1. If during an intervention the baby experiences Apnea/Bradycardic/Desaturation events
requiring nursing stimulation or intervention during the training--hold future
interventions for one session.

2. If the interventions are held for 3 consecutive sessions, hold interventions for a full
day (24 hours).

3. If interventions are held for 3 days (72 hours) and if GA is <32 weeks when ready to
restart therapy sessions, then complete another 10 days of interventions.

4. If interventions are held for 3 days (72 hours) and if GA is >32 weeks when ready to
restart therapy, then complete the remaining N interventions sessions for a total of 10
days of therapy.

5. If interventions are held for 3 days (72 hours) and the infant is on full oral feeds
when ready to restart therapy interventions then discontinue any remaining
interventions sessions.

The Interventions

Infants in the Treatment and Control group will receive orocutaneous stimulation up to four
times daily during the first 30 minutes of a tube (gavage) feeding session to achieve an
average of 30 therapy sessions distributed over a two week period.

Infants assigned to the either group will be offered the pacifier by gently placing the
pacifier on the lips. The pacifier should not be forced into the mouth and should not be
moved in any manner that would represent any form of patterned input such as moving the
pacifier in and out, tapping on the lips or face or massaging the mouth or oral facial
structure.

All other preparatory, infant positioning, and sampling conditions will be equal among
groups. The healthcare team will continue to promote feeding and growth at the standard of
care for babies in both groups.

Treatment Group

Infants in the Treatment group will receive the NTrainer System® patterned synthetic
orocutaneous stimulation. A single NTrainer intervention runs for 20 minutes and involves
three 3 minute sessions during which the pacifier pulses. The pulsing sessions are separated
by 5.5 min breaks where the pacifier is quiet.

Control Group

Infants assigned to the control group will receive an orocutaneous intervention in which the
infant will be offered a 20 minute non-nutritive sucking opportunity with a 'quiet'
pacifier.

Breast Feeding Non-nutritive breastfeeding and nutritive breastfeeding practice will not be
altered or changed by the interventions. The availability of the mother will be taken into
consideration for the scheduling of any intervention sessions and no study intervention will
interfere with breastfeeding behavior.

Safety To help ensure the safety of the study participants the heart rate, oxygen
saturation, and blood pressure will be monitored throughout the therapy session.

Inclusion Criteria

- Birth Gestational age 26 0/6 - 30 6/7 weeks

Exclusion Criteria

- Chromosomal abnormalities

- Congenital anomalies included but not limited to

- craniofacial malformation

- cyanotic congenital heart disease

- gastroschisis

- omphalocele

- diaphragmatic hernia or other major gastrointestinal anomalies

- Major neurological anomaly

- Infants with history of surgical necrotizing enterocolitis (stage III)

- Infants with vocal cord paralysis

- Infants with neonatal seizures

- Infants with meningitis at time of enrollment

- Infants who are nippling all feeds at the time of enrollment

- Infants with narcotic abstinence syndrome (NAS)

- Infants enrolled in another clinical study