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Withdrawn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
About this trial
This is an interventional supportive care trial for Premature
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
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
NCT ID
NCT04561700
First Posted
September 5, 2020
Last Updated
January 6, 2022
Sponsor
University of Alabama at Birmingham
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Withdrawn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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