Clinical trial NCT04256889: Use Of Nfant(R) Technology Feeding System For Infants Less Than 30 Weeks GA
Official title: Use of Nfant(R) Technology Feeding System As An Adjunct To Visual Assessment And Cue-Based Feedings For Infants Born Less Than 30 Weeks Gestational Age (GA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Extreme Prematurity
Lead sponsor: Woman's
Sponsor class: OTHER
Collaborators: name: NFANT Labs
First posted: 2020-02-05
Enrollment: 23
Sex: ALL
Minimum age (years): 22
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with decreased Feeding Related Length of Stay
timeFrame: up to 48 hours
measure: Number of participants with Full oral feeding
timeFrame: 33 weeks through study completion, an average of 1 year
measure: Number of participants with hospital readmission for feeding related issues
timeFrame: Within the first 21 days after Neonatal Intensive Care Unit discharge
measure: Number of inpatient Modified Barium Swallow Study (MBSS)/repeat MBSS
timeFrame: Neonatal Intensive Care Unit admit through study completion, an average of 1 year
measure: Number of participants with increased Sucking Efficiency
timeFrame: 31 weeks GA through study completion, an average of 1 year
measure: Number of participants with increased Sucking Amplitude
timeFrame: 31 weeks GA through study completion, an average of 1 year
measure: Number of participants with increased Sucking Frequency
timeFrame: 31 weeks GA through study completion, an average of 1 year
measure: Number of participants with increased Sucking Duration
timeFrame: 31 weeks GA through study completion, an average of 1 year
measure: Number of participants with increased Sucking Smoothness
timeFrame: 31 weeks GA through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Woman's Hospital
state: Louisiana
Study officials:
affiliation: Woman's Hospital, Louisiana
name: Nanette Gremillion, PT, MS, CNT
role: PRINCIPAL_INVESTIGATOR
References: