Clinical trial NCT01158391: Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding
Official title: Trial of Patterned Oral Somatosensory Entrainment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant, Extremely Premature
Length of Stay
Feeding
Keywords: Premature Birth
Lead sponsor: KC BioMediX, Inc
Sponsor class: INDUSTRY
Collaborators: name: Innara Health, Inc.
First posted: 2010-07-08
Enrollment: 210
Sex: ALL
Minimum age (years): 26
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The length of time to reach 100% full oral feeds
timeFrame: 14 days on average
Secondary outcomes:
measure: The reduction in length of stay as a result of therapy
timeFrame: 24 days on average
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa Clara Valleye Medical Center
state: California
city: Bronx
country: United States
facility: Montefiore Medical Center Weiler Hopsital
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center - Wakefield Hopsital
state: New York
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: San Antonio
country: United States
facility: North Central Baptist Hospital
state: Texas
Study officials:
affiliation: Santa Clara Valley Medical Center
name: Dongli Song, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song D, Jegatheesan P, Nafday S, Ahmad KA, Nedrelow J, Wearden M, Nemerofsky S, Pooley S, Thompson D, Vail D, Cornejo T, Cohen Z, Govindaswami B. Patterned frequency-modulated oral stimulation in preterm infants: A multicenter randomized controlled trial. PLoS One. 2019 Feb 28;14(2):e0212675. doi: 10.1371/journal.pone.0212675. eCollection 2019.