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Clinical Trials/NCT04561700
NCT04561700
Withdrawn
N/A

Nutritive Sucking Patterns in Premature Infants: A Randomized Trial

University of Alabama at Birmingham0 sitesOctober 2021
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ConditionsPrematureLight-For-Dates Without Mention of Fetal Malnutrition, UnspecifiedFeeding Patterns

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premature
Sponsor
University of Alabama at Birmingham
Primary Endpoint
Time to independent oral feeding
Status
Withdrawn
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2021
End Date
June 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ariel A. Salas

Assistant Professor

University of Alabama at Birmingham

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

Outcomes

Primary Outcomes

Time to independent oral feeding

Time Frame: Birth to 120 days

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

Secondary Outcomes

  • Length of hospital stay(Birth to 120 days)
  • Postnatal age at discharge(Birth to 120 days)
  • Growth rate during the transition from tube to oral feeding(Birth to 120 days)
  • Tube feeding events per day during the transition from tube to oral feeding.(Birth to 120 days)

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