A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period

September 29, 2022 updated by: National Cheng-Kung University Hospital

A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period - Explore Clinical Facts, Evaluate Intervention Effects and Develop Clinical Guideline

The coordination of sucking, swallowing, and breathing during the transition from gavage to oral feeding is a challenge for preterm infants. Efficient management of the feeding transition without other comorbidities can not only improve their oral movements and gastrointestinal function development, facilitate their oral feeding learning behavior, but also facilitate them to direct breastfeeding, improve mother-infant attachment, and ultimately reduce the length of hospitalization. However, the current status of strategies in supporting preterm infants throughout their feeding transition are inconsistent, and lack of guidelines and monitor indicators based on existing evidence.

This project proposed a three-year plan the explore the current situation, examine effective strategies for care bundles, and further develop a new clinical guideline that can be implemented in the future. The first year of this research will use chart review among two neonatal intensive care units of Medical Center from Taipei and Tainan. A semi-structured interview and questionnaire (DSCS-N) will be used to explore nurses' knowledge, attitude and skills of developmental care; and the experience of caring for preterm infants during feeding transition in the neonatal intensive care units. In addition, gestational age, body weight, gavage and oral feeding amount, and special events happened during feeding will be recorded and analyzed.

The second year, an experimental with a stratified random assignment and repeated measure design will be used with feeding transition care bundles. 120 preterm infants will be recruited and assigned to experimental or control group. The subjects will be fed by the routine care approach or by the feeding transition approach in one neonatal intensive care unit. Intervention components include oral stimulation and cue-based feeding during the transition to oral feeding. Study measures will include physical indicators, POFRAS and EFS during feeding to evaluate the implementation and guide further development of the clinical guideline.

The third year of guideline development will follow Bowker and the National Health Insurance Bureau which including 5 stage. The results of this guideline can offer better recommendations to support preterm infants' oral development, provide cue-based feeding, and help them succeed in the transition to oral nutrition.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Other: The premature infant oral motor intervention (PIOMI)

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Taiwan
- - Tainan, Taiwan, 70101
    - National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 8 months (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Preterm infant born less then 33 weeks
Fraction of inspired oxygen(FiO2) less then 30%
Can tolerance enteral feeding

Exclusion Criteria:

Using ventilator(except non-invasive ventilator)
Complications including Hypoxic Ischemic Encephalopathy (HIE), Intraventricular Hemorrhage (IVH) ≥Grade III, Periventricular Leukomalacia (PVL), Necrotizing Enterocolitis(NEC) ≥Stage II
Congenital abnormalities including chromosomal abnormalities, congenital anomalies of digestive system, cleft lip and palate
Because of custody problem or can't get the inform consent of the preterm infant's parents/guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PIOMI treat group Preterm infant receive oral massage using the premature infant oral motor intervention (PIOMI)	Other: The premature infant oral motor intervention (PIOMI) The premature infant oral motor intervention (PIOMI) is an oral motor program that provides assisted movement to activate muscle contraction and provides movement against resistance to build strength in the areas of the mouth necessary for feeding. It is designed to increase the maturation of neural structures, improving their ability to suck and swallow. Other Names: Cue-based feeding
No Intervention: Routine care group Preterm infant receive routine care of neonatal intensive care unit(NICU)

Participant Group / Arm

Intervention / Treatment

Experimental: PIOMI treat group

Preterm infant receive oral massage using the premature infant oral motor intervention (PIOMI)

Other: The premature infant oral motor intervention (PIOMI)

The premature infant oral motor intervention (PIOMI) is an oral motor program that provides assisted movement to activate muscle contraction and provides movement against resistance to build strength in the areas of the mouth necessary for feeding. It is designed to increase the maturation of neural structures, improving their ability to suck and swallow.

Other Names:

Cue-based feeding

No Intervention: Routine care group

Preterm infant receive routine care of neonatal intensive care unit(NICU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm infant's oral feeding readiness Time Frame: Change from day 1(Baseline) up to day 7 in oral stimulation phase	We use the Preterm Oral Feeding Readiness Assessment Scales (POFRAS) to assess preterm infants' readiness to start oral feeding. The scale comprised of 5 five categories including corrected Gestational Age, Behavioral Organization (3 item), Oral Posture (2 item), Oral Reflexes (4 item), Nonnutritive Sucking (8 item) with a total of 18 items to evaluate. Each item score from 0~2, the higher the score means that the preterm infant has better oral feeding preparation.	Change from day 1(Baseline) up to day 7 in oral stimulation phase
Preterm infant's oral feeding skills Time Frame: From day 1(Baseline) up to the day 30 in cue-base feeding phase	Using Early Feeding Skills Assessments for Preterm Infants (EFS). The Early Feeding Skills Assessments for Preterm Infants (EFS) checklist is to assess preterm infants' oral feeding readiness (before feeding; yes/no), oral feeding skill (when feeding; all/most/some/none; never/occasionally/often), oral feeding tolerance (after feeding; yes/no) and feeding descriptors(after feeding).	From day 1(Baseline) up to the day 30 in cue-base feeding phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight change Time Frame: Change from day 1(baseline) up to the day 200.	body weight change in grams	Change from day 1(baseline) up to the day 200.
hospital stay length(days) Time Frame: From day 1 up to the day 200.	How many days from admission(birth day) to discharge(leave) hospital.	From day 1 up to the day 200.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Collaborators

National Taiwan University Hospital

Ministry of Science and Technology, Taiwan

Investigators

Principal Investigator: Mei-Chih Huang, Department of Nursing, College of Medicine, National Cheng-Kung University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

July 31, 2020

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

MOST 107-2314-B-006-009-MY3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period