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

NCT04256889 | Completed FDA Device

• 1 other identifier: RP-19-013
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity; Extreme Prematurity

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• Number of participants with hospital readmission for feeding related issues

  Phone Follow-up

  Within the first 21 days after Neonatal Intensive Care Unit discharge

• 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

• Number of participants with increased Sucking Efficiency

  nfant(R) feeding metrics

  31 weeks GA through study completion, an average of 1 year

• Number of participants with increased Sucking Amplitude

  nfant(R) feeding metrics

  31 weeks GA through study completion, an average of 1 year

• Number of participants with increased Sucking Frequency

  nfant(R) feeding metrics

  31 weeks GA through study completion, an average of 1 year

• Number of participants with increased Sucking Duration

  nfant(R) feeding metrics

  31 weeks GA through study completion, an average of 1 year

• Number of participants with increased Sucking Smoothness

  nfant(R) feeding metrics

  31 weeks GA through study completion, an average of 1 year

Study Arms (1)

nfant(R) feeding system

EXPERIMENTAL

Addition of nfant(R) technology, along with visual assessments and cue-based feeding practices, to facilitate an infant's progression to full oral feeding and potentially improve developmentally supportive feeding practices.

Device: nfant(R) feeding system

Interventions

nfant(R) feeding system DEVICE

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

nfant(R) feeding system

Eligibility Criteria

• Age: 22 Weeks - 29 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants less than or equal to 29 6/7 weeks gestation at birth

You may not qualify if:

• 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

Sponsors & Collaborators

• Woman's: lead
• NFANT Labs: collaborator

Study Sites (1)

Woman's Hospital

Baton Rouge, Louisiana, 70817, United States

Location

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

• Nanette Gremillion, PT, MS, CNT

  Woman's Hospital, Louisiana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: February 5, 2020
• Study Start: January 15, 2020
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)