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

Preterm Infant Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03755999
• Other study ID #: MOST 107-2314-B-006-009-MY3
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: July 31, 2023

Study information

• Verified date: July 2022
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 33 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Feeding Behavior
• Feeding Patterns
• Premature Birth
• Preterm Infant

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (3)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	Ministry of Science and Technology, Taiwan, National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (50)

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from day 1(Baseline) up to day 7 in oral stimulation phase
Primary	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).	From day 1(Baseline) up to the day 30 in cue-base feeding phase
Secondary	Body weight change	body weight change in grams	Change from day 1(baseline) up to the day 200.
Secondary	hospital stay length(days)	How many days from admission(birth day) to discharge(leave) hospital.	From day 1 up to the day 200.