Use Of Nfant(R) Technology Feeding System For Infants Less Than 30 Weeks GA

Prematurity Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04256889
• Other study ID #: RP-19-013
• Status: Completed
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: March 13, 2024

Study information

• Verified date: March 2024
• Source: Woman's
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 13, 2024
• Est. primary completion date: March 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Weeks to 29 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Extreme Prematurity
• Premature Birth
• Prematurity

Intervention

Device:
• nfant(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

Locations

Country	Name	City	State
United States	Woman's Hospital	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Woman's	NFANT Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with decreased Feeding Related Length of Stay	Starts when an infant can take 5 ml of breast milk or formula orally with autonomic stability	up to 48 hours
Primary	Number of participants with Full oral feeding	Gestational age at which the infant first completes 90% of minimal ordered volumes without requiring gavage feeds for a 24 hour period	33 weeks through study completion, an average of 1 year
Primary	Number of participants with hospital readmission for feeding related issues	Phone Follow-up	Within the first 21 days after Neonatal Intensive Care Unit discharge
Primary	Number of inpatient Modified Barium Swallow Study (MBSS)/repeat MBSS	Swallow Studies	Neonatal Intensive Care Unit admit through study completion, an average of 1 year
Primary	Number of participants with increased Sucking Efficiency	nfant(R) feeding metrics	31 weeks GA through study completion, an average of 1 year
Primary	Number of participants with increased Sucking Amplitude	nfant(R) feeding metrics	31 weeks GA through study completion, an average of 1 year
Primary	Number of participants with increased Sucking Frequency	nfant(R) feeding metrics	31 weeks GA through study completion, an average of 1 year
Primary	Number of participants with increased Sucking Duration	nfant(R) feeding metrics	31 weeks GA through study completion, an average of 1 year
Primary	Number of participants with increased Sucking Smoothness	nfant(R) feeding metrics	31 weeks GA through study completion, an average of 1 year