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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

February 15, 2010
February 16, 2010
January 2008
October 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01069731 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Non-nutritive Suck (NNS) Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants
Comparison of NNS Performance Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants Using the NTrainer Device

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Preterm Birth
Not Provided
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.
Barlow SM, Finan DS, Lee J, Chu S. Synthetic orocutaneous stimulation entrains preterm infants with feeding difficulties to suck. J Perinatol. 2008 Aug;28(8):541-8. Epub 2008 Jun 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
November 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
30 Weeks to 36 Weeks
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01069731
WakeMed Study 748
No
Thomas Young, MD, WakeMEd
KC BioMediX, Inc
Not Provided
Principal Investigator: Thomas Young, MD WakeMed Health and Hospitals
KC BioMediX, Inc
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP