NCT03755999

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

Status unknown NA Last updated 30 September 2022

What this trial tests

NA trial testing The premature infant oral motor intervention (PIOMI) in Preterm Infant in 120 participants. Status unknown.

Timeline

1 November 2018

Primary endpoint
31 July 2020

31 July 2023

Quick facts

Lead sponsor	National Cheng-Kung University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	120
Start date	1 November 2018
Primary completion	31 July 2020
Estimated completion	31 July 2023
Sites	1 location across Taiwan

Drugs / interventions tested

• The premature infant oral motor intervention (PIOMI)

Conditions studied

• Preterm Infant — all drugs for Preterm Infant →
• Feeding Behavior — all drugs for Feeding Behavior →
• Feeding Patterns — all drugs for Feeding Patterns →

Sponsor

National Cheng-Kung University Hospital

Who can join

Under 33 Weeks, any sex, with Preterm Infant or Feeding Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.