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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03755999
Enrollment
120
Registered
2018-11-28
Start date
2018-11-01
Completion date
2023-07-31
Last updated
2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Behavior, Feeding Patterns, Preterm Infant

Keywords

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

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.

Interventions

OTHERThe 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.

Sponsors

Ministry of Science and Technology, Taiwan
CollaboratorOTHER_GOV
National Taiwan University Hospital
CollaboratorOTHER
National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
No minimum to 33 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Preterm infant's oral feeding readinessChange from day 1(Baseline) up to day 7 in oral stimulation phaseWe 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 skillsFrom day 1(Baseline) up to the day 30 in cue-base feeding phaseUsing 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

MeasureTime frameDescription
Body weight changeChange from day 1(baseline) up to the day 200.body weight change in grams
hospital stay length(days)From day 1 up to the day 200.How many days from admission(birth day) to discharge(leave) hospital.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026