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

NCT01158391 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2016-05-18

No results posted yet for this study

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.

Conditions

  • Infant, Extremely Premature
  • Length of Stay
  • Feeding

Interventions

DEVICE

NTrainer® Intervention

DEVICE

Control Intervention

Sponsors & Collaborators

  • Innara Health, Inc.

    collaborator INDUSTRY

  • KC BioMediX, Inc

    lead INDUSTRY

Principal Investigators

  • Dongli Song, MD · Santa Clara Valley Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
26 Weeks
Max Age
31 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01158391 on ClinicalTrials.gov