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NCT01069731 Clinical Trial

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

Preterm Birth Clinical Trial

Official title:
Comparison of NNS Performance Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants Using the NTrainer Device

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01069731
Other study ID # WakeMed Study 748
Secondary ID
Status Completed
Phase N/A
First received February 15, 2010
Last updated February 16, 2010
Start date January 2008
Est. completion date November 2009

Study information
Verified date February 2010
Source KC BioMediX, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date November 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 30 Weeks to 36 Weeks
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States WakeMed Raleigh North Carolina

Sponsors (1)
Lead Sponsor Collaborator
KC BioMediX, Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1038/jp.2008.57. Epub 2008 Jun 12. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. First Weeks of Life No
Secondary To describe the progression of NNS waveform pattern and NNS-STI values in normal premature infants as they mature to term postmenstrual age. Mature to full term postmenstrual age No
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