MedPath

Effect of massage on weight and neuro muscular maturity

Recruiting
Conditions
Preterm neonates
Registration Number
CTRI/2017/08/009541
Lead Sponsor
JIPMER
Brief Summary

**Study Title**

Effect of tactile-kinesthetic stimulation on weight gain and neuromuscular maturity in preterm neonates.

**Research hypothesis**

The Tactile-kinesthetic stimulation is effective in weight gain & neuromuscular maturity among preterm neonates.

**objective of the study**

To assess the effectiveness of tactile-kinesthetic stimulation on weight gain & neuromuscular maturity in preterm neonates

***Names of the groups to be studied -*****2 groups**

Group I: Control group – Preterm neonates with conventional/routine care.

Group II: Experimental group – Preterm neonates with Tactile-Kinesthetic Stimulation

***Procedure***:

´ Tactile-kinesthetic stimulation will be done for 10 consecutive days.

ü  In the experimental group, tactile-kinesthetic stimulation will be given for 15 minutes, 2 times a day for 10 days. Control group will not receive any intervention.

ü  The intervention will be done about 1 hour after feeds with the neonate nursed under a radiant warmer, fully undressed except for the diapers. A temperature probe and SpO2 monitor will be attached. The heart rate and SPO2 will be monitored before and after the procedure. If the neonate starts crying or passes stools/urine during the session, the procedure will be stopped temporarily till the diapers are changed and the neonate becomes calm again. In the control group the neonates will be exposed to similar conditions to which the test babies were exposed - they will be nursed naked 1 hour after feeds and subjected to routine handling like changing diapers, etc and their heart rate and oxygen saturation will be recorded.

ü  The mother’s of cases and controls will be told not to provide any kind of massage to the neonates, except for KMC.

ü  Weight and neuromuscular maturity will be assessed before and after intervention period.

ü  Blinding will be done in the post-intervention assessment period in order to avoid bias.

ü   After intervention period the neonate’s neuromuscular maturity & weight outcome will be assessed twice by a person other than the investigator who was not informed of the intervention group allocation  ie.,

´ At the 10th day of  intervention

´ At the corrected age of 40 weeks.

 The baseline scores and scores after intervention at 10th day and 40th corrected week will be compared.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
All
Target Recruitment
96
Inclusion Criteria

Neonates who are born between 32 and <37 weeks of gestation Neonates with stable vital signs Neonates who are not on oxygen therapy.

Exclusion Criteria

Neonates who have undergone surgery Neonates with any congenital anomalies Neonates who are critically ill.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
to find out if tactile-kinesthetic stimulation leads to better weight gain and neuromuscular maturity in the preterm neonates10 days
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Neonatal Intensive Care Unit

🇮🇳

Pondicherry, PONDICHERRY, India

Neonatal Intensive Care Unit
🇮🇳Pondicherry, PONDICHERRY, India
Dr Nivedita Mondal
Principal investigator
8098912969
nive.m8@gmail.com

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