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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04561700
Other study ID # 300004412
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2021
Est. completion date June 2023

Study information

Verified date January 2022
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2023
Est. primary completion date July 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 60 Days
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Reporting of sucking patterns captured by Instrumented Bottle
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.
Control
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Outcome

Type Measure Description Time frame Safety issue
Primary Time to independent oral feeding Time interval in days from introduction of oral feeding to full independent oral feeding Birth to 120 days
Secondary Postnatal age at discharge Age in days at the time of hospital discharge Birth to 120 days
Secondary Length of hospital stay Total number of hospitalization days Birth to 120 days
Secondary Growth rate during the transition from tube to oral feeding Weekly weight gain in g/kg/day Birth to 120 days
Secondary Tube feeding events per day during the transition from tube to oral feeding. Daily count of tube feeding events Birth to 120 days
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