NCT01158391

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

6.1 years

First QC Date

June 24, 2010

Last Update Submit

May 17, 2016

Conditions

Infant, Extremely PrematureLength of StayFeeding

Keywords

Premature Birth

Outcome Measures

Primary Outcomes (1)

  • The length of time to reach 100% full oral feeds

    Time (in days) from initiation of oral feedings to the first oral intake that results in 100% oral feeding (definition of 100% oral feeding: no gavage supplementation and taking at least 120 milliliters per kilogram per day for 48 consecutive hours of breast milk, fortified breast milk or preterm formula as ordered by the child's physician.

    14 days on average

Secondary Outcomes (1)

  • The reduction in length of stay as a result of therapy

    24 days on average

Study Arms (2)

NTrainer® Intervention

EXPERIMENTAL

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.

Device: NTrainer® Intervention

Control Intervention

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.

Device: Control Intervention

Interventions

NTrainer® InterventionDEVICE
Also known as: KC BioMedix NTrainer, NTrainer System, Actifier
NTrainer® Intervention
Control InterventionDEVICE
Also known as: Non-nutritive Sucking, NNS Opportunity
Control Intervention

Eligibility Criteria

Age26 Weeks - 31 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Santa Clara Valleye Medical Center

San Jose, California, 95128, United States

Location

Montefiore Medical Center Weiler Hopsital

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Wakefield Hopsital

The Bronx, New York, 10466, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

North Central Baptist Hospital

San Antonio, Texas, 78258, United States

Location

Related Publications (1)

  • 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.

    PMID: 30817764DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Dongli Song, MD

    Santa Clara Valley Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2010

First Posted

July 8, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

US(5)