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

NCT03755999 | Unknown

• 1 other identifier: MOST 107-2314-B-006-009-MY3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant; Feeding Behavior; Feeding Patterns

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Body weight change

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

• hospital stay length(days)

  From day 1 up to the day 200.

Study Arms (2)

PIOMI treat group

EXPERIMENTAL

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

Other: The premature infant oral motor intervention (PIOMI)

Routine care group

NO INTERVENTION

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

Interventions

The premature infant oral motor intervention (PIOMI) OTHER

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.

Also known as: Cue-based feeding

PIOMI treat group

Eligibility Criteria

• Age: Up to 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infant born less then 33 weeks
• Fraction of inspired oxygen(FiO2) less then 30%
• Can tolerance enteral feeding

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator
• National Taiwan University Hospital: collaborator

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 70101, Taiwan

Location

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MeSH Terms

Conditions

Premature Birth; Feeding Behavior

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior, Animal; Behavior

Study Officials

• Mei-Chih Huang

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: November 28, 2018
• Study Start: November 1, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2023
• Last Updated: September 30, 2022

Record last verified: 2022-07

Locations

TW (1)