Clinical trial NCT06263127: Sensory Motor Interventions on Preterm Infants
Official title: The Effectiveness of Prefeeding Oral Stimulation and Infant Massage on Preterm Infants in the Neonatal Care Unit
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preterm Infants
Keywords: NICU
Massage
Preterm infants
oral stimulation
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 80
Sex: ALL
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Oral intake
timeFrame: the 1st, 8th, and 14th day of the intervention period
measure: Transition time of oral feeding
timeFrame: from the date of the first day of the intervention until the date of full oral feeding, assesed up to 4 weeks
Secondary outcomes:
measure: weight gain
timeFrame: 14 days
measure: Hospital stay
timeFrame: from the date of the first day of the intervention until the date of hospital discharge, assessed up to 6 weeks
measure: Neonatal Neurobehavioral Examination-Chinese Version(NNE-C)
timeFrame: the 1st and 14th day of the intervention period
measure: Infant/Toddler Sensory Profile-Chinese Version(ITSP-C)
timeFrame: conducted at around 3 months of corrected age
measure: Premature Bottle Feeding Questionnaire(PBFQ)
timeFrame: conducted at around 3 months old of corrected age
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: