| CTRI Number |
CTRI/2024/05/066856 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [multi stimulation ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Multi-stimulation on time taken for transition to full oral feeding (Spoon/ Paladai) in preterm infants |
|
Scientific Title of Study
|
Effect of Multi-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, KLE Universiity |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar , KLE Hospital Road
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, KLE University |
| Address |
Department of Neonatology,
Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road
Belgaum
KARNATAKA
590010
India |
| Phone |
9844232586 |
| 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, KLE University |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar , KLE Hospital Road
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 |
| 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 Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road.
Belgaum
KARNATAKA |
8978330201
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 Multi-stimulation |
Routine newborn care as per NICU Protocols will be given and no intervention will be given.
No stimulation will be given to the preterm infants. |
| Intervention |
Preterm infants receiving Multi-stimulation |
Consists of
1. Tactile Stimulation
2. Kinaesthatic stimulation
3. Oro motor stimulation
These stimulation will be performed two times a day before feeding for 15 minutes for 7 days by a trained person (Nurse , mother , investigator )
Total duration of the intervention is 15 minutes two times a day for 7 consecutive days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
1.Inborn babies between 30 to 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 5 cm for 24 to 48 hours.
3. Parents willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Major Congenital Anomalies ( Craniofacial malformation, Congenital diaphragmatic hernia , Intestinal obstruction and others)
2. Grade 3 and 4 Intraventricular hemorrhage
3. Necrotizing enterocolitis stage 2 and 3
4. Perinatal asphyxia with HIE stage 2 and 3
Any other condition where intervention cannot be delivered. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. 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 the 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
|
N/A |
|
Date of First Enrollment (India)
|
13/05/2024 |
| 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 coordinating sucking, swallowing and breathing which are essential components of successful feeding. Feeding issues are also related to gut immaturity, and neuromuscular incoordination leading to poor tolerance of enteral feeding. Feeding tolerance results in prolonged hospitalisation, increased risk of sepsis and predisposition to serious complications. Stimulation is the best key to success in acheiving oral feeding perfomance and sustaining breastfeeding. There are several interventions which help in reducing feeding intolerance and the time taken to acheive full oral feeding in preterm babies and enhance the nutritional and physiological status. Oromotor stimulation with non nutritive sucking and tactile stimulation improves the neuromotor development , emotional bonding , better sleep wake patterns, and increases the oral feeding skills.
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