Nutritive Sucking Patterns in Premature Infants

NCT04561700 | Withdrawn DMC

• 1 other identifier: 300004412
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Time to independent oral feeding

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

  Birth to 120 days

Secondary Outcomes (4)

• Postnatal age at discharge

  Birth to 120 days

• Length of hospital stay

  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

Study Arms (2)

Reporting of sucking patterns captured by Instrumented Bottle

EXPERIMENTAL

Weekly reporting on objective measurements of sucking activity during oral feeding

Diagnostic Test: Reporting of sucking patterns captured by Instrumented Bottle

Control

SHAM COMPARATOR

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

Diagnostic Test: Control

Interventions

Reporting of sucking patterns captured by Instrumented Bottle DIAGNOSTIC_TEST

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.

Reporting of sucking patterns captured by Instrumented Bottle

Control DIAGNOSTIC_TEST

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.

Control

Eligibility Criteria

• Age: 7 Days - 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Premature Birth; Feeding Behavior

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior, Animal; Behavior

Study Officials

• Ariel A. Salas, MD, MSPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: September 24, 2020
• Study Start: October 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: June 1, 2023
• Last Updated: January 10, 2022

Record last verified: 2022-01