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Completed

NCT Number: NCT04256889

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

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.

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Key information

Conditions

Prematurity Extreme Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

22 week–29 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Woman's Hospital

Baton Rouge, Louisiana, 70817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Number of participants with decreased Feeding Related Length of Stay

    Time frame: up to 48 hours

    Starts when an infant can take 5 ml of breast milk or formula orally with autonomic stability

  2. Number of participants with Full oral feeding

    Time frame: 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

  3. Number of participants with hospital readmission for feeding related issues

    Time frame: Within the first 21 days after Neonatal Intensive Care Unit discharge

    Phone Follow-up

  4. Number of inpatient Modified Barium Swallow Study (MBSS)/repeat MBSS

    Time frame: Neonatal Intensive Care Unit admit through study completion, an average of 1 year

    Swallow Studies

  5. Number of participants with increased Sucking Efficiency

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

    nfant(R) feeding metrics

  6. Number of participants with increased Sucking Amplitude

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

    nfant(R) feeding metrics

  7. Number of participants with increased Sucking Frequency

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

    nfant(R) feeding metrics

  8. Number of participants with increased Sucking Duration

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

    nfant(R) feeding metrics

  9. Number of participants with increased Sucking Smoothness

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

    nfant(R) feeding metrics

Sponsors and collaborators

Lead sponsor

Woman's

Other

Collaborators

  • NFANT Labs

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2020
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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