Preterm Infants
Conditions
Keywords
NICU, Massage, Preterm infants, oral stimulation
Brief summary
Preterm infants experiencing bottle feeding difficulties will be included in this study. Two distinct interventions, oral stimulation (OS) and infant massage (IM), will be administered in this study. The objective of this clinical trial is to compare the effectiveness of these two approaches, either individually or in combination, in improving the feeding performance and development of participants.
Detailed description
Currently, two rehabilitation approaches, Prefeeding oral stimulation (OS) and infant massage (IM), are often used by health professionals to facilitate preterm infants' oral feeding abilities. The purpose of this study is to compare the effectiveness of prefeeding OS and the combined approach of prefeeding OS and IM in improving feeding performance and development of preterm infants. Participants will randomly allocated to two groups and receive either OS or combined OS plus IM. Prefeeding OS is a 5-minute oral sensorimotor intervention, containing peri- and intra-oral stimulation for 3 minutes and pacifier sucking for 2 minutes. IM is a 15-minute intervention, including 5-min manual massage on the infant's head, neck, back, upper limbs, and lower limbs twice and 5-min passive exercise of moving the infant's arms and legs once. The OS group will receive OS twice a day for 10 days. The combined group will receive OS once and IM once a day for 10 days. Both groups will undergo a bottle feeding assessment before, mid-term, and after the intervention period. Neurodevelopmental assessments will be conducted before and after the intervention period. Additionally, the investigator will conduct chart review to collect participants' birth and medical data. The primary outcomes are feeding performance parameters (e.g., the rate of milk transfer in the first 5 minutes of feeding, total oral intake volume, and milk leakage during bottle feeding) and neurodevelopment outcomes. Secondary outcomes include weight gain and hospital stay. Furthermore, a follow-up evaluation on feeding questionnaire at home and sensory processing function will be conducted when the infants reach three months of corrected age.
Interventions
BEHAVIORALoral stimulation
Prefeeding OS is a 5-minute oral sensorimotor intervention, containing peri- and intra-oral stimulation for 3 minutes and pacifier sucking for 2 minutes.
BEHAVIORALinfants massage
IM is a 15-minute intervention, involving 5-min manual stroking on the infant's head, neck, back, upper limbs, and lower limbs twice and 5-min gentle flexion and extension exercises on the infant's arms and legs.
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 34 Weeks
Healthy volunteers
Yes
Inclusion criteria
1. \< 34 weeks' gestational age 2. 34\ 40 weeks' postmenstrual age at enrollment 3. being fed by oral for at least 2 days but with poor feeding performance defined as consuming less than 80% of the prescribed volume for the half or more feedings 4. weaning the ventilator and maintaining stable physiological status
Exclusion criteria
1. Congenital anomalies 2. Confirmed or suspected chromosomal or genetic abnormalities 3. Unsolved seizure, sepsis, necrotizing enterocolitis(NEC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral intake | the 1st, 8th, and 14th day of the intervention period | The volume of oral intake in the feeding |
| Transition time of oral feeding | from the date of the first day of the intervention until the date of full oral feeding, assesed up to 4 weeks | the number of days from the first day of the intervention to the day at full oral feeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Neurobehavioral Examination-Chinese Version(NNE-C) | the 1st and 14th day of the intervention period | It consists of three subtests: (1) Muscle Tone and Movement Patterns (12-36 points), (2) Primitive Reflexes (13-39 points), and (3) Behavioral Responses (12-36 points). A higher score means more mature motor pattern. |
| weight gain | 14 days | weight gain from the first day to the last day of the intervention period |
| Premature Bottle Feeding Questionnaire(PBFQ) | conducted at around 3 months old of corrected age | A self-reported questionnaire consists of 15-item feeding problematic behaviors. The primary caregiver will fill out each question using a 4-point scale according to the infant's feeding performance at home. The feeding score is from 15 to 60 points. A higher score means poorer feeding performance. |
| Infant/Toddler Sensory Profile-Chinese Version(ITSP-C) | conducted at around 3 months of corrected age | A self-reported questionnaire completed by the primary caregiver will be used to assess sensory processing of infants from birth to three years old. It consists of 5 subscales: General Perception, Auditory Processing, Visual Processing, Tactile Processing, and Vestibular Processing. The items of the five subscales can be classified into 4 quadrants: Low registration (13-65 points), sensory seeking (6-30 points), sensation sensitivity (12-60 points), and sensory avoiding (5-25 points). A lower score means a stronger sensory quadrant pattern. |
| Hospital stay | from the date of the first day of the intervention until the date of hospital discharge, assessed up to 6 weeks | the number of days from the first day of the intervention to the day of discharge |
Countries
Taiwan
Outcome results
None listed