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

NCT01069731 | Completed

• 1 other identifier: WakeMed Study 748
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 30 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KC BioMediX, Inc: lead

Study Sites (1)

WakeMed

Raleigh, North Carolina, 27610, United States

Location

Related 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.

  PMID: 18548084 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Thomas Young, MD

  WakeMed Health and Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 15, 2010
• First Posted: February 17, 2010
• Study Start: January 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 17, 2010

Record last verified: 2010-02

Locations

US (1)