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Nutritive Sucking Patterns in Premature Infants

Primary Purpose

Premature, Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified, Feeding Patterns

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reporting of sucking patterns captured by Instrumented Bottle
Control
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature

Eligibility Criteria

7 Days - 60 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Birthweight < 1000 grams
  • Gestational age < 32 weeks of gestation
  • Full enteral feeding established before or on postnatal day 21
  • Oral feeding initiated before or at 33 weeks of postmenstrual age

Exclusion Criteria:

  • Major congenital/chromosomal anomalies
  • Patent ductus arteriosus causing significant cardiovascular symptoms
  • History of necrotizing enterocolitis stage 2 or greater

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Reporting of sucking patterns captured by Instrumented Bottle

    Control

    Arm Description

    Weekly reporting on objective measurements of sucking activity during oral feeding

    Weekly reporting on traditional measurements of sucking activity during oral feeding (no objective measurements reported)

    Outcomes

    Primary Outcome Measures

    Time to independent oral feeding
    Time interval in days from introduction of oral feeding to full independent oral feeding

    Secondary Outcome Measures

    Postnatal age at discharge
    Age in days at the time of hospital discharge
    Length of hospital stay
    Total number of hospitalization days
    Growth rate during the transition from tube to oral feeding
    Weekly weight gain in g/kg/day
    Tube feeding events per day during the transition from tube to oral feeding.
    Daily count of tube feeding events

    Full Information

    First Posted
    September 5, 2020
    Last Updated
    January 6, 2022
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04561700
    Brief Title
    Nutritive Sucking Patterns in Premature Infants
    Official Title
    Nutritive Sucking Patterns in Premature Infants: A Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Unfunded
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    July 2022 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In this pilot trial, the investigators will determine the feasibility of monitoring nutritive sucking patterns to facilitate the transition from tube to oral feeding in extremely-low-birth weight (ELBW) infants
    Detailed Description
    In this parallel-group randomized controlled trial, ELBW infants (birthweight < 1000 grams) will be randomly assigned in a 1:1 ratio to either weekly reporting on objective measurements of sucking activity during oral feeding (intervention group) or usual care without information on sucking activity (control group).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature, Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified, Feeding Patterns

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Reporting of sucking patterns captured by Instrumented Bottle
    Arm Type
    Experimental
    Arm Description
    Weekly reporting on objective measurements of sucking activity during oral feeding
    Arm Title
    Control
    Arm Type
    Sham Comparator
    Arm Description
    Weekly reporting on traditional measurements of sucking activity during oral feeding (no objective measurements reported)
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Reporting of sucking patterns captured by Instrumented Bottle
    Intervention Description
    In the intervention group, data on nutritive sucking and feeding cues captured by the Instrumented Bottle will be made available to speech therapists to document the feeding session and provide written recommendations in their weekly report.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Control
    Intervention Description
    In the control group, the information captured by the Instrumented Bottle will not be made available to speech therapists and therefore, will not be used to document a feeding session or provide weekly recommendations.
    Primary Outcome Measure Information:
    Title
    Time to independent oral feeding
    Description
    Time interval in days from introduction of oral feeding to full independent oral feeding
    Time Frame
    Birth to 120 days
    Secondary Outcome Measure Information:
    Title
    Postnatal age at discharge
    Description
    Age in days at the time of hospital discharge
    Time Frame
    Birth to 120 days
    Title
    Length of hospital stay
    Description
    Total number of hospitalization days
    Time Frame
    Birth to 120 days
    Title
    Growth rate during the transition from tube to oral feeding
    Description
    Weekly weight gain in g/kg/day
    Time Frame
    Birth to 120 days
    Title
    Tube feeding events per day during the transition from tube to oral feeding.
    Description
    Daily count of tube feeding events
    Time Frame
    Birth to 120 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Days
    Maximum Age & Unit of Time
    60 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Birthweight < 1000 grams Gestational age < 32 weeks of gestation Full enteral feeding established before or on postnatal day 21 Oral feeding initiated before or at 33 weeks of postmenstrual age Exclusion Criteria: Major congenital/chromosomal anomalies Patent ductus arteriosus causing significant cardiovascular symptoms History of necrotizing enterocolitis stage 2 or greater
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ariel A. Salas, MD, MSPH
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Nutritive Sucking Patterns in Premature Infants

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