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Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants

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ClinicalTrials.gov Identifier: NCT02696343
Recruitment Status : Recruiting
First Posted : March 2, 2016
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
Tufts Medical Center
CIRI/CHI Institute for Research and Innovation
California Institute for Medical Research
Texas Tech University
Children’s Hospital of Orange County
Information provided by (Responsible Party):
University of Nebraska Lincoln

Brief Summary:
Two innovative approaches, pulsatile orocutaneous entrainment of non-nutritive suck via orosensory entrainment (NTrainer) device technology and serial salivary gene expression analyses, will be merged to examine the relation between gene expression, oral somatosensory stimulation, feeding behavior, and neurodevelopmental outcomes at 18 months corrected age (CA) on 180 extremely preterm infants [EPIs] (24 0/7-26 6/7 GA and 27 0/7 - 28 6/7 GA) enrolled at three neonatal intensive care units: Catholic Health Initiative (CHI) Health St. Elizabeth (Lincoln, NE), Tufts Medical Center (Boston, MA), and Santa Clara Valley Medical Center (San Jose, CA). EPIs will be randomized to a blind pacifier (SHAM) or PULSED NTrainer treatment groups, and stratified by GA, sex, and bronchopulmonary dysplasia status (BPD vs non-BPD). We hypothesize that the combination of the NTrainer® intervention for improved oral feeding skills, along with objective salivary gene expression data to monitor response to treatment and feeding development, will result in a novel, objective, and personalized approach to neonatal oral feeding and reduce the duration of time to attain oral feeds while improving feeding, growth and neurodevelopmental outcomes at 18 months' CA.

Condition or disease Intervention/treatment Phase
Infant, Extremely Low Birth Weight Feeding Behavior Device: NTrainer Device: SHAM blind pacifier Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants
Study Start Date : April 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EPI experimental
Preterm infants randomized to receive the PULSED orocutaneous somatosensory stimulation from the NTrainer during tube feedings.
Device: NTrainer
pulsed orocutaneous stimulation paired with tube feedings

Sham Comparator: EPI control
Preterm infants randomized to receive the Sham (blind pacifier) during tube feedings.
Device: SHAM blind pacifier
regular green Soothie pacifier paired with tube feedings




Primary Outcome Measures :
  1. Salivary gene expression [ Time Frame: Quantify gene expression probability from salivary samples beginning at 30 wks post-menstrual age, and repeated sampling every 3 days thereafter during the infant's stay in neonatal intensive care unit (NICU) for an average of 14 samples, up to 60 days. ]
    Plexin A1 (PLXNA1), Plexin A3 (PLXNA3), Neuropeptide Y2 receptor (NPY2R), Wingless-type integration site family (WNT3), Adenosine-monophosphate-activated protein kinase (AMPK), and Nephronophthisis 4 (NPHP4) gene expression


Secondary Outcome Measures :
  1. National Institute Child Human Development (NICHD) Neonatal Research Network feed-growth questionnaire [ Time Frame: 18 months corrected age (CA) ]
  2. Bayley III Developmental Scales [ Time Frame: 18-24 months corrected age (CA) ]
  3. Non-nutritive suck (NNS) bursts/minute [ Time Frame: Beginning at 30 wks post-menstrual age, and repeated biomechanical sampling of suck bursts/min (2 min sample) every 3 days thereafter during the infant's stay in the NICU for an average of 12 NNS samples, and up to 60 days. ]
    NNS Bursts/min

  4. Time-to-transition to full oral feed [ Time Frame: Time expressed in days for an infant to attain full oral feed (100% PO), assessed on a daily basis beginning at 30 weeks post-menstrual age (PMA) through hospital stay in the NICU, for an average of 56 %PO measures sampled over 8 weeks. ]
    Time to Full Oral Feed

  5. Non-nutritive suck cycles/min [ Time Frame: Beginning at 30 wks post-menstrual age, and repeated biomechanical sampling of suck compressions/min (2-min sample) every 3 days thereafter during the infant's stay in the NICU for an average of 12 NNS samples, and up to 60 days. ]
    NNS Cycles/min



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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Extremely preterm infants (EPIs) born between 24 0/7 and 28 6/7 weeks' GA, as determined by obstetric ultrasound at < 15 weeks or last menstrual period
  • Enroll EPIs once they have a corrected PCA of ≥ 29 weeks
  • Approximately equal numbers of males and females, no exclusion based on race/ethnicity

Exclusion Criteria:

  • Chromosomal and congenital anomalies including craniofacial malformation, nervous system anomalies, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia and/or other major gastrointestinal anomalies
  • Congenital infection
  • No documented GA
  • Severe IUGR (3%)
  • Head circumference < 10th or > 90th percentile
  • Intracranial hemorrhage grades III and IV, seizures
  • Meningitis
  • Neurological examination showing abnormal tone or movements of all extremities for PCA
  • History of necrotizing enterocolitis (stage II and III)
  • Culture-positive sepsis at the time of study enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696343


Contacts
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Contact: Steven M Barlow, PhD 4024723956 steven.barlow@unl.edu

Locations
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United States, California
Children's Hospital of Orange County Not yet recruiting
Los Angeles, California, United States, 92868-4203
Contact: Kushal Bhakta, MD    714-509-4373    kbhakta@choc.org   
Contact: Phuong Dao, JD    714-509-4086    pdao@choc.org   
Santa Clara Valley Medical Center Recruiting
San Jose, California, United States, 95128-2604
Contact: Dongli Song, MD, PhD    408-885-5420    dongli.song@hhs.sccgov.org   
Principal Investigator: Dongli Song, MD, PhD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111-1526
Contact: Jill L Maron, MD    617-636-0766    jmaron@tuftsmedicalcenter.org   
Principal Investigator: Jill L Maron, MD         
United States, Nebraska
CHI St. Elizabeth's Medical Center Completed
Lincoln, Nebraska, United States, 68512
Sponsors and Collaborators
University of Nebraska Lincoln
Tufts Medical Center
CIRI/CHI Institute for Research and Innovation
California Institute for Medical Research
Texas Tech University
Children’s Hospital of Orange County
Investigators
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Principal Investigator: Steven M Barlow, PhD University of Nebraska
Principal Investigator: Jill L Maron, MD Tufts Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Nebraska Lincoln
ClinicalTrials.gov Identifier: NCT02696343     History of Changes
Other Study ID Numbers: UNL IRB Project ID #15446
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Nebraska Lincoln:
somatosensory stimulation
orocutaneous
gene expression
Additional relevant MeSH terms:
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Birth Weight
Body Weight
Signs and Symptoms