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

N

National Cheng-Kung University

Status

Invitation-only

Conditions

Feeding Behavior
Preterm Infant
Feeding Patterns

Treatments

Other: The premature infant oral motor intervention (PIOMI)

Study type

Interventional

Funder types

Other

Identifiers

NCT03755999
MOST 107-2314-B-006-009-MY3

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

Under 33 weeks old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups

PIOMI treat group
Experimental group
Description:
Preterm infant receive oral massage using the premature infant oral motor intervention (PIOMI)
Treatment:
Other: The premature infant oral motor intervention (PIOMI)
Routine care group
No Intervention group
Description:
Preterm infant receive routine care of neonatal intensive care unit(NICU)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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