This trial is active, not recruiting.

Conditions infant, extremely premature, length of stay, feeding
Treatments ntrainer® intervention, control intervention
Sponsor KC BioMediX, Inc
Collaborator Innara Health, Inc.
Start date May 2010
End date June 2016
Trial size 210 participants
Trial identifier NCT01158391, KC_BMDX_002


The primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age) who undergo the NTrainer System® training will transition to full oral feeds faster than the control group (i.e. the study group will be superior to the control).

The secondary hypothesis is that the infants in the NTrainer System® experimental group will have shorter lengths of stay.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
NTrainer® Intervention - Infants in the experimental group will receive the NTrainer System patterned synthetic orocutaneous stimulation during the first 30 minutes of a tube (gavage) feeding session. The intervention may be provided up to 4 times daily to achieve an average of 30 sessions distributed over a two week period.
ntrainer® intervention KC BioMedix NTrainer
(Sham Comparator)
Control Intervention - Infants in the Control group will be provided orocutaneous stimulation with a 'quiet pacifier' during the first 30 minutes of a tube (gavage) feeding session. The intervention may be provided up to 4 times daily to achieve an average of 30 sessions distributed over a two week period.
control intervention Non-nutritive Sucking

Primary Outcomes

The length of time to reach 100% full oral feeds
time frame: 14 days on average

Secondary Outcomes

The reduction in length of stay as a result of therapy
time frame: 24 days on average

Eligibility Criteria

Male or female participants from 26 weeks up to 31 weeks old.

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

Additional Information

Official title Trial of Patterned Oral Somatosensory Entrainment
Principal investigator Dongli Song, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by KC BioMediX, Inc.