A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period
NCT ID: NCT03755999
Last Updated: 2022-09-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-11-01
Study Completion Date
2023-07-31
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Preterm Infant
Feeding Behavior
Feeding Patterns
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
DOUBLE
Participants
Caregivers
Study Groups
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PIOMI treat group
Preterm infant receive oral massage using the premature infant oral motor intervention (PIOMI)
Group Type
EXPERIMENTAL
The premature infant oral motor intervention (PIOMI)
Intervention Type
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.
Routine care group
Preterm infant receive routine care of neonatal intensive care unit(NICU)
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
OTHER
Other Intervention Names
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Cue-based feeding
Eligibility Criteria
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Inclusion Criteria
* Preterm infant born less then 33 weeks
* Fraction of inspired oxygen(FiO2) less then 30%
* Can tolerance enteral feeding
* 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
* 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
Maximum Eligible Age
33 Weeks
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ministry of Science and Technology, Taiwan
OTHER_GOV
Sponsor Role
collaborator
National Taiwan University Hospital
OTHER
Sponsor Role
collaborator
National Cheng-Kung University Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mei-Chih Huang
Role: PRINCIPAL_INVESTIGATOR
Department of Nursing, College of Medicine, National Cheng-Kung University
Locations
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National Cheng Kung University Hospital
Tainan City, , Taiwan
Site Status
Countries
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Taiwan
References
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Other Identifiers
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MOST 107-2314-B-006-009-MY3
Identifier Type: -
Identifier Source: org_study_id
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