Usefulness of multisensory stimulation on motor and mental development, behavioural status, physical growth and physiological parameters in preterm neonates. A Randomized controlled trial.
- Conditions
- Preterm [premature] newborn [other],
- Registration Number
- CTRI/2023/08/057016
- Lead Sponsor
- JIPMER
- Brief Summary
This study is the randomized control trial to know the effect of multisensory stimulation on motor and mental development, behavioural status, physical growth and physiological parameters in preterm neonates. Clinical characteristics of neonate will be collected from the case sheet. According to the sequence order the subject will be allocate to the experimental and control group. The Experimental group will receive multisensory stimulation for 10 days. In both the groups physical growth will be assessed on day 10 & the corrected gestational age of 40 weeks then once a month till 6 months.
Physiological parameters will be assessed daily till discharge.Behavioural status will also be assessed daily till discharge.Motor and mental development will be assessed at 3rd month &6th month.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 212
Inclusion Criteria: 1.Neonates delivered between 34-37 weeks of gestation 2.Neonates who are hemodynamically stable.
- Exclusion Criteria: Neonates with any of the following criteria, 1.Neonates with weight <1000gm.
- 2.Neonates with weight >2500gm.
- 3.Neonates with major congenital anomalies.
- 4.Neonates who have undergone surgery.
- 5.Neonates who are critically ill.
- 6.Neonates who are on oxygen therapy.
- 7.Neonates with hypoxic encephalopathy.
- 8.Neonates with hypoglycemic seizures 9.significant birth trauma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •To assess the effect of multisensory stimulation on behavioural status among preterm infants. Day 1,Day10, Week 40. •To assess the effect of multisensory stimulation on physical growth (Weight, Length, Head circumference) among preterm infants. Day 1,Day10, Week 40. •To assess the effect of multisensory stimulation on physiological parameters (Heart rate, Respiratory rate, SpO2, Temperature). Day 1,Day10, Week 40.
- Secondary Outcome Measures
Name Time Method •To assess the effect of multisensory stimulation on motor & mental development among preterm infants at 3 month & 6 month. •To identify the clinical characteristics associated with developmental, behavioural, physical & physiological outcome among the preterm neonates.
Trial Locations
- Locations (1)
JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
JIPMER🇮🇳Pondicherry, PONDICHERRY, IndiaDr P VetriselviPrincipal investigator9894459434Vetriselvijipmer1967@gmail.com