| CTRI Number |
CTRI/2021/05/033796 [Registered on: 25/05/2021] Trial Registered Prospectively |
| Last Modified On: |
20/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Tactile-kinesthetic stimulation (massage therapy) ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effect of short and long duration of massage on weight gain in preterms |
|
Scientific Title of Study
|
Effect of short versus long period of tactile-kinesthetic stimulation on weight gain in very preterm neonates- a parallel arm randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha P |
| Designation |
Junior Resident |
| Affiliation |
JIPMER PUDUCHERRY |
| Address |
Department of Pediatrics, JWCH
Jawaharlal Institute of post graduate medical education and research, JIPMER
Department of pediatrics,
JWCH
Jawaharlal Institute of Postgraduate Medical Education and research JIPMER PUDUCHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443091159 |
| Fax |
|
| Email |
nishavinoth21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nivedita Mondal |
| Designation |
Additional Professor |
| Affiliation |
JIPMER PUDUCHERRY |
| Address |
Department of Neonatology , JWCH,
Jawaharlal Institute of Postgraduate Medical Education and research JIPMER
D NAGAR PUDUCHERRY
Department of Neonatology,
JWCH,
Jawaharlal Institute of Postgraduate Medical Education and research JIPMER Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8098912969 |
| Fax |
|
| Email |
nive.m8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nivedita Mondal |
| Designation |
Additional Professor |
| Affiliation |
JIPMER PUDUCHERRY |
| Address |
Department of Neonatology, JWCH
Jawaharlal Institute of Postgraduate Medical Education and research JIPMER
D NAGAR PUDUCHERRY
Department of Neonatology JWCH
Jawaharlal Institute of Postgraduate Medical Education and research, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8098912969 |
| Fax |
|
| Email |
nive.m8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and research JIPMER,D Nagar, Puducherry 605 006 . |
|
|
Primary Sponsor
|
| Name |
Nisha P |
| Address |
Department of pediatrics
JIPMER |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nisha |
JIPMER |
Department of Neonatology
JIPMER
Pondicherry
PONDICHERRY |
9443091159
nishavinoth21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER IEC PONDICHERRY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84-P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tactile-kinesthetic stimulation |
Twice a day for 15 minutes atleast 6 hours apart for 7 days |
| Intervention |
Tactile-kinesthetic stimulation |
Twice a day for 15 minutes atleast 6 hours apart till 40 weeks of corrected age. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Day(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
Very preterm neonates between 28-32 weeks gestational age at birth, confirmed by first trimester ultrasonogram or New Ballard Score in the absence of first trimester USG.Hemodynamically stable, off oxygen.On minimum 30 ml per kg per day feeds |
|
| ExclusionCriteria |
| Details |
1)Syndromic or with major malformations
2) Underwent major surgeries
3) Neurologically abnormal including those with hydrocephalus and intraventricular hemorrhage >grade II
4) Any fracture due to birth trauma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight gain |
At 40 weeks corrected age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay |
At discharge |
| Neonatal co-morbidities after starting the intervention including- sepsis, necrotizing enterocolitis stage 2, apnea requiring CPAP and readmissions. |
At 40 weeks corrected age |
| Days to transition from Oro-gastric to paladai feeds and then to full direct breast feeds |
At 40 weeks of corrected age |
| Any disorder of bonding as detected in the Postpartum Bonding Questionnaire at enrollment and at 40 weeks corrected age |
At enrollment, and at 40 weeks corrected age |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Non yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomized controlled trial to compare the weight gain at 40 weeks corrected age between preterm neonates (28-32 weeks gestational age ) subjected to tactile-kinesthetic stimulation (massage) for long period till 40 weeks of corrected age to those subjected to the same for a shorter period of 7 days. Effect of the tactile-kinesthetic stimulation on duration of hospital stay, neonatal co-morbidities, feeding pattern and maternal bonding will be studied. |