Effect of multisensory intervention- auditory, tactile, visual, vestibular stimulation with maternal participation and guidance on the health outcomes- behavioral response, feeding progression and weight gain of preterm neonates at a selected hospital, Mangaluru.
- Conditions
- Preterm [premature] newborn [other],
- Registration Number
- CTRI/2021/07/034879
- Lead Sponsor
- Sonya Sequeira
- Brief Summary
The proposed study is a Randomised control trial on effectiveness of multisensory intervention with maternal participatory guidance on the health status of preterm neonates at a selected hospital, Mangaluru. Ethical clearance and required permissions for the study will be obtained appropriately. The preterm neonates and their mothers who fulfil the inclusion and exclusion criteria will be randomly assigned to the experimental (n=97) and control group (n=97) using simple random sampling technique. Informed consent will be obtained from the mothers. The preterm neonates in the experimental group will receive the multisensory intervention (ATVV stimulation) from the mothers which will be taught using a video, handout and guidance by the researcher along with routine NICU care. The control group will only receive routine NICU care. The experimental group will receive the multisensory intervention for 10 consecutive days and the observations will be done on the 1st, 5th and 10th days of intervention.The primary outcomes such as behavioural state, feeding progression and weight gain in preterm neonates will be assessed using the Andersons behavioural state scale, feeding progression scale for preterm neonates, weight record respectively. the gathered data will be subjected to statistical anlysis using repeated measures ANNOVA, Post-hoc analysis and Chi square test.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 197
Preterm neonates, • 28 -<32 weeks (very preterm) and 33 -<36 weeks gestation (moderate to late preterm) at birth as per modified Ballard score • who are hemodynamically stable during recruitment for study • weighing≥1000 grams Mothers, • of preterm neonates • who are willing to stay in the hospital with preterm neonate for a minimum of 10 days after being recruited in the study • who are able to speak and read Kannada/ Malayalam/ English language.
Preterm neonates, • with congenital anomaly, necrotizing enterocolitis, brain injury, chronic lung disease • with prenatal drug exposure Mothers, •not willing to participate in the study •with psychological or psychiatric illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method preterm neonates, day 1, day 5, day10 behavioral state day 1, day 5, day10 feeding progression day 1, day 5, day10 weight gain day 1, day 5, day10
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Yenepoya Medical College Hospital
🇮🇳Kannada, KARNATAKA, India
Yenepoya Medical College Hospital🇮🇳Kannada, KARNATAKA, IndiaDr Prakash R M SaldanhaPrincipal investigator9845081567saldanha.drprakask@gmail.com