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Comparison of Non-nutritive Suck (NNS) Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants

This study has been completed.
Sponsor:
Information provided by:
KC BioMediX, Inc
ClinicalTrials.gov Identifier:
NCT01069731
First received: February 15, 2010
Last updated: February 16, 2010
Last verified: February 2010
  Purpose

This is a research study to quantitatively assess the development of non-nutritive suck (NNS) and feeding readiness in preterm infants using a novel device, the NTrainer©, and to compare this with two clinical assessment tools, NOMAS and EFS.


Condition
Preterm Birth

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of NNS Performance Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants Using the NTrainer Device

Further study details as provided by KC BioMediX, Inc:

Primary Outcome Measures:
  • To describe NNS pressure waveforms and NNS-STI values in normal premature infants with gestational ages 30 to 36 weeks during the first week of life. [ Time Frame: First Weeks of Life ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the progression of NNS waveform pattern and NNS-STI values in normal premature infants as they mature to term postmenstrual age. [ Time Frame: Mature to full term postmenstrual age ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: January 2008
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Infants born at 30 to 36 weeks gestation
Infants will be considered eligible if they are born at 30 to 36 weeks gestation and have no exclusion criteria.

Detailed Description:

Fifteen minutes before feeding, the mobile NTrainer recording station will be positioned cribside. Following a brief exam of physiologic state, using the Oral Feeding Readiness Assessment portion of the EFS, the infant will be cradled in a supportive inclined posture, swaddled, with limbs positioned at midline, and background/overhead lighting dimmed in the area to promote eye contact with the tester. Sampling of NNS behavior will not be initiated until the infant is in an optimal behavioral state, i.e., drowsy to active alert (state 3 or 4 or 5 as described by the Naturalistic Observation of Newborn Behavior, Newborn Individualized Developmental Care and Assessment Program; NIDCAP). The infant will be presented with the NTrainer pacifier, and several contiguous 30-second blocks of NNS nipple compression data will be sampled using the NeoSuck RT software. The infant will remain connected to the usual NICU monitors at all times for observation of respiration, heartbeat and oxygen saturation.

After the NTrainer data collection is completed, the baby will be fed by his or her nurse or parents as directed in the care plan. If the baby is able to feed by mouth, one of the investigators will observe the feeding, and perform 1) a NOMAS evaluation during the first 2 minutes of the feeding, and 2) an EFS assessment after the feeding is completed.

Infants will be studied in 2 sessions each day beginning at Day 4 to 7 of life, then twice weekly (2 sessions per day, 2 days per week) until hospital discharge.

  Eligibility

Ages Eligible for Study:   30 Weeks to 36 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Infants born prematurely may suffer multiple adverse events in the NICU, and these experiences may negatively impact normal developmental processes of immature cardiorespiratory, gastrointestinal and central nervous systems. As a result, many infants have at least transient difficulties learning to successfully manage oral feedings. Oral feeding difficulties in the NICU may prolong the time to discharge, cause significant parental anxiety, and persist throughout infancy.

Criteria

Inclusion Criteria:

  • Born at 30 to 36 weeks gestation and have no exclusion criteria.

Exclusion Criteria:

  • Significant birth defects.
  • Breathing difficulties severe enough to require being on a ventilator or nasal CPAP for more than 2 hours after birth.
  • Any oxygen requirement at Day 4 of life.
  • Any neurologic problems, including seizures or frequent apnea spells.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069731

Locations
United States, North Carolina
WakeMed
Raleigh, North Carolina, United States, 27610
Sponsors and Collaborators
KC BioMediX, Inc
Investigators
Principal Investigator: Thomas Young, MD WakeMed Health and Hospitals
  More Information

Additional Information:
Publications:
Responsible Party: Thomas Young, MD, WakeMEd
ClinicalTrials.gov Identifier: NCT01069731     History of Changes
Other Study ID Numbers: WakeMed Study 748
Study First Received: February 15, 2010
Last Updated: February 16, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on November 20, 2014