| CTRI Number |
CTRI/2024/04/065421 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Oro motor stimulation] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of pre feed oromotor stimulation |
|
Scientific Title of Study
|
A study to assess the Effect of pre feed oromotor stimulation on selected neonatal outcomes among preterm neonates admitted in NICU of a selected hospital |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepa R |
| Designation |
Msc nursing student |
| Affiliation |
St Johns Medical college and hospital |
| Address |
St Johns College of nursing
Sarjapur road Koramangala
Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
8971528391 |
| Fax |
|
| Email |
deeparamachandra830@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Shiny Mathew |
| Designation |
Professor and HOD of child health nursing |
| Affiliation |
St Johns Medical college and hospital |
| Address |
St Johns College of nursing
Sarjapur road
Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9880475060 |
| Fax |
|
| Email |
shajanshiny@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Shiny Mathew |
| Designation |
Professor and HOD of child health nursing |
| Affiliation |
St Johns Medical college and hospital |
| Address |
St Johns College of nursing
Sarjapur road
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9880475060 |
| Fax |
|
| Email |
shajanshiny@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns medical college and hospital
St johns college of nursing |
|
|
Primary Sponsor
|
| Name |
Deepa R |
| Address |
St Johns College of nursing
Sarjapur road
Bangalore |
| 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 |
| Mrsshiny mathew |
Hospital |
St johns medical college and hospital
Sarjapur road
Bengaluru karnataka
Bangalore
KARNATAKA |
9880475060
shajanshiny@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z761||Encounter for health supervision and care of foundling, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oromotor stimulation for preterm neonates |
Pre feed oromotor stimulation given for preterm neonates in experimental group and compared with control group, who is not received oromotor stimulation |
| Intervention |
Pre feed Oromotor stimulation on preterm neonates |
Pre feed oromotor stimulation given for preterm neonates who are stable and in control group receives only standard care, total sample size is 58, after 5 days of intervention results are compared with both groups. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Preterm neonates between 28 to 37 weeks of gestation. Preterm neonates who is hemodynamically stable and admitted in NICU (Neonatal Intensive Care Unit). Who are on NPO (Nil per oral) and who are on Ryle’s tube feed..
|
|
| ExclusionCriteria |
| Details |
Preterm neonates with congenital anomalies.
and who is on ventilator and who are critical or unstable.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To achieve early gavage feed to oral feed |
45 minutes per day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decreased hospital stay & weight gain. |
45 minutes per day |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
17/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Oro motor stimulation given 3 times a day for 5 consecutive days on preterm neonates who is stable, on day 0 and day 6 assessed for oral feeding ability and weights changes. |