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

Primary Purpose

Preterm Infant, Feeding Behavior, Feeding Patterns

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

The premature infant oral motor intervention (PIOMI)

About this trial

This is an interventional supportive care trial for Preterm Infant focused on measuring preterm infants, transitional feeding period, cue-based care, clinical guidelines

Eligibility Criteria

undefined - 33 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PIOMI treat group

Routine care group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Preterm infant's oral feeding readiness

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.

Preterm infant's oral feeding skills

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).

Secondary Outcome Measures

Body weight change

body weight change in grams

hospital stay length(days)

How many days from admission(birth day) to discharge(leave) hospital.

Full Information

NCT ID

NCT03755999

First Posted

August 22, 2018

Last Updated

September 29, 2022

Sponsor

National Cheng-Kung University Hospital

Collaborators

Ministry of Science and Technology, Taiwan, National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03755999

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

November 1, 2018 (Actual)

Primary Completion Date

July 31, 2020 (Actual)

Study Completion Date

July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cheng-Kung University Hospital

Collaborators

Ministry of Science and Technology, Taiwan, National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Infant, Feeding Behavior, Feeding Patterns

Keywords

preterm infants, transitional feeding period, cue-based care, clinical guidelines

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PIOMI treat group

Arm Type

Experimental

Arm Description

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

Arm Title

Routine care group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

The premature infant oral motor intervention (PIOMI)

Other Intervention Name(s)

Cue-based feeding

Intervention Description

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.

Primary Outcome Measure Information:

Title

Preterm infant's oral feeding readiness

Description

Time Frame

Change from day 1(Baseline) up to day 7 in oral stimulation phase

Title

Preterm infant's oral feeding skills

Description

Time Frame

From day 1(Baseline) up to the day 30 in cue-base feeding phase

Secondary Outcome Measure Information:

Title

Body weight change

Description

body weight change in grams

Time Frame

Change from day 1(baseline) up to the day 200.

Title

hospital stay length(days)

Description

How many days from admission(birth day) to discharge(leave) hospital.

Time Frame

From day 1 up to the day 200.

10. Eligibility

Sex

All

Maximum Age & Unit of Time

33 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mei-Chih Huang

Organizational Affiliation

Department of Nursing, College of Medicine, National Cheng-Kung University

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

70101

Country

Taiwan

12. IPD Sharing Statement

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

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