Extreme Prematurity, Prematurity
Conditions
Brief summary
The purpose of the study is to utilize the objective data provided by the nfant® suite of products, along with current NICU visual assessment and cue-based feeding practices, in order to determine if feeding performance outcomes and clinical decision making for individualized feeding plans for premature infants born less than 30 weeks PMA are impacted.
Detailed description
Will obtain 5 official readings using the nfant(R) technology: baseline between 31 0/7 weeks and 32 0/7 weeks Post-Menstrual Age (PMA) with No Flow nipple, Cue-Based Feeding Readiness Reading with No Flow nipple no sooner than 33 0/7 weeks PMA, Post-Sequencing Reading with Extra Slow Flow nipple, Slow Flow nipple Reading, and Standard nipple Reading. The technology will also be utilized between readings 2 to 3 times a week. Phone Follow-up 2 question survey will be administered 21 days after discharge from Neonatal Intensive Care Unit.This survey entails routine questions regarding re-admission, to clarify if readmission was within 21 days of discharge, and if the reason for re-admission was feeding related.
Interventions
DEVICEnfant(R) feeding system
Use of nfant(R) technology feeding system as an adjunct to visual assessment and cue-based feedings for infants born less than 30 weeks GA
Sponsors
NFANT Labs
Woman's
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective case matched controlled study (not a cohort). Enrolled infants will be matched with infants in the National Medical Index based on gestational age, gender, weight and comorbidities. A two cohort, mixed regression model would be used to correlate nfant® metrics to clinical outcomes.
Eligibility
Sex/Gender
ALL
Age
22 Weeks to 29 Weeks
Healthy volunteers
No
Inclusion criteria
* Infants less than or equal to 29 6/7 weeks gestation at birth
Exclusion criteria
* Infants 30 weeks or greater gestation at birth * Infants with known or suspected congenital anomalies or chromosomal abnormalities * Infants with diagnoses known to interfere with oral feeding, including, but not limited to cleft lip. cleft palate, gastroschisis, Tracheoesophageal fistula, micrognathia. * History of Intraventricular hemorrhage Grade 3 or 4 or Periventricular Leukomalacia * Infants with known diagnoses known to interfere with Gastrointestinal absorption, including, but not limited to, Necrotizing Enterocolitis requiring surgical intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with decreased Feeding Related Length of Stay | up to 48 hours | Starts when an infant can take 5 ml of breast milk or formula orally with autonomic stability |
| Number of participants with Full oral feeding | 33 weeks through study completion, an average of 1 year | Gestational age at which the infant first completes 90% of minimal ordered volumes without requiring gavage feeds for a 24 hour period |
| Number of participants with hospital readmission for feeding related issues | Within the first 21 days after Neonatal Intensive Care Unit discharge | Phone Follow-up |
| Number of inpatient Modified Barium Swallow Study (MBSS)/repeat MBSS | Neonatal Intensive Care Unit admit through study completion, an average of 1 year | Swallow Studies |
| Number of participants with increased Sucking Efficiency | 31 weeks GA through study completion, an average of 1 year | nfant(R) feeding metrics |
| Number of participants with increased Sucking Amplitude | 31 weeks GA through study completion, an average of 1 year | nfant(R) feeding metrics |
| Number of participants with increased Sucking Frequency | 31 weeks GA through study completion, an average of 1 year | nfant(R) feeding metrics |
| Number of participants with increased Sucking Duration | 31 weeks GA through study completion, an average of 1 year | nfant(R) feeding metrics |
| Number of participants with increased Sucking Smoothness | 31 weeks GA through study completion, an average of 1 year | nfant(R) feeding metrics |
Countries
United States
Outcome results
None listed