Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01069731
Status:
COMPLETED
Last Update Posted:
2010-02-17
First Post:
2010-02-15
Brief Title:
Comparison of Non-nutritive Suck NNS Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants
Sponsor:
KC BioMediX Inc
Organization:
KC BioMediX Inc
Study Overview
Official Title:
Comparison of NNS Performance Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants Using the NTrainer Device
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 backgroundoverhead 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 ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None