| CTRI Number |
CTRI/2024/08/071871 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Tactile and Kinaesthetic stimulation ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Touch and Movement therapy on time taken for transition to full oral feeding ( spoon / paladai ) in preterm infants |
|
Scientific Title of Study
|
Effect of Tactile and Kinaesthetic stimulation on time taken for transition to full oral feeding ( spoon / paladai ) in preterm infants: One year hospital based Randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Somayajula Venkata Sri Lalitha Priyanka |
| Designation |
PG Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar , KLE Hospital Road
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
08978330201 |
| Fax |
|
| Email |
lalithapriyanka97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S M Dhaded |
| Designation |
PROFESSOR |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Neonatology,
Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road
Belgaum
KARNATAKA
590010
INDIA
Belgaum
KARNATAKA
590010
India |
| Phone |
09844232586 |
| Fax |
|
| Email |
drdhadedsm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Somayajula Venkata Sri Lalitha Priyanka |
| Designation |
PG Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar , KLE Hospital Road
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
08978330201 |
| Fax |
|
| Email |
lalithapriyanka97@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital, Jawaharlal nehru medical college, KLE University, Belagavi |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College, KLE University, Belagavi |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar , KLE Hospital Road
Belgaum
KARNATAKA
590010
INDIA |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Somayajula Venkata Sri Lalitha Priyanka |
KLEs Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, KLE University, Belagavi |
Department of Pediatrics
Ground floor
Belgaum
KARNATAKA |
08978330201
lalithapriyanka97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Preterm infants not receiving Tactile and kinaesthetic stimulation. |
Routine newborn care as per NICU Protocols will be given and no intervention ( tactile and kinaesthetic stimulation ) will be given. No stimulation will be given to the preterm infants. |
| Intervention |
Preterm infants receiving Tactile and Kinaesthetic stimulation |
The study intervention consists of 1. Tactile stimulation and Kinaesthetic stimulation.These stimulations will be performed two times a day 20 minutes before feeding, for 15 minutes for 7 consecutive days by a trained person ( Nurse/ Mother / Investigator ) using all aseptic precautions with gloved fingers.
The massage sessions comprise of three segments which will be two five - minute phases of tactile stimulation and one five-minute phase of kinaesthetic stimulation given during middle phase.
Tactile stimulation: The neonate will be placed in prone position and stroked with fingers of both hands of therapist for 5 one minute periods over each region from the anterior fontanelle to the C7 vertebrae and to the acromium on both sides followed by upper back, thigh to the foot and lastly shoulder to the hands and both arms simultaneously.
Kinaesthetic stimulation : The neonate will be placed in the supine position, this phase consists of six passive flexion/ extension movements each lasting approximately 10 seconds in the following sequence starting from right arm to left arm followed by right and left leg followed by both legs simultaneously. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
1. Inborn babies between 30-34 weeks of gestation
2. Medically stable with minimal respiratory support ( CPAP with FiO2 less than equal to 40% and PEEP less than equal to 5cm for 24 to 48 hours
3. Parents willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Major congenital anomalies ( Craniofacial malformation , Hypoplastic left heart, Neural tube defect, Congenital diaphragmatic hernia, Intestinal obstruction and others.)
2. Grade 3 and 4 Intraventricular hemorrhage
3. Necrotising enterocolitis stage 2 and 3
4. Perinatal asphyxia with HIE stage 2 and 3
5. Any other conditions where intervention cannot be delivered |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Transition time to full oral feeds (Spoon/ paladai feeds ) |
The infants will be monitored from the date of admission till the date of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Weekly weight gain
2. Length of hospital stay |
Weight will be recorded weekly once since admission till discharge.
Length of hospital stay will be calculated from the date of admission to the date of discharge. |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Feeding problems are the major issues in preterm infants. They have problems in coordinated sucking, swallowing and breathing which are essential components of successful feeding. Feeding issues are related to gut immaturity, and neuromuscular incoordination leading to poor tolerance to enteral feeding. Feeding intolerance results in prolonged hospitalisation , increased risk of sepsis and predisposition to serious complications. Stimulation is the best key to success in acheiving oral feeding performance and sustaining breast feeding. There are several interventions which help in reducing feeding intolerance and time taken to acheive full oral feeding in preterm babies and enhance the nutritional and physiological status. Tactile and Kinaesthetic stimulation improves the neuromotor development, emotional bonding, better sleep wake patterns , and increases the oral feeding skills. |