| CTRI Number |
CTRI/2024/12/078763 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Early oral motor stimulation for promoting oral feeding in preterm infants |
|
Scientific Title of Study
|
Early oral motor stimulation for promoting oral feeding in preterm infants : A randomized controlled 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 PALLAVI CHAUHAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room no. 3012, Department of Pediatrics, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9759733022 |
| Fax |
|
| Email |
drpallavichauhan1309@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PREETI LATA RAI |
| Designation |
PROFESSOR |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room no. 3012, Department of Pediatrics, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8057383699 |
| Fax |
|
| Email |
dr.plr21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PALLAVI CHAUHAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room no. 3012, Department of Pediatrics, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly 243006
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9759733022 |
| Fax |
|
| Email |
drpallavichauhan1309@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 3012, Department of Pediatrics, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly 243006 |
|
|
Primary Sponsor
|
| Name |
DR PALLAVI CHAUHAN |
| Address |
Room no. 3012, Department of Pediatrics, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly 243006 |
| 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 PALLAVI CHAUHAN |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
Room no. 3012, Department of Pediatrics, Rohilkhand Medical College and Hospital
Bareilly
UTTAR PRADESH |
9759733022
drpallavichauhan1309@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee (IEC), Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh 243006 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 |
Preterm babies fulfilling the inclusion criteria will be enrolled in the study after obtaining written and informed consent from parents. Every alternate baby enrolled will be assigned to group 1 and group 2 respectively. Group 1 babies will be receiving OMS along with KMC and NNS |
| Comparator Agent |
Group 2 |
Group 2 babies will be receiving only NNS and KMC and constitute control group |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All preterm inborn or outborn babies and who will be hemodynamically stable admitted in NICU |
|
| ExclusionCriteria |
| Details |
All sick babies and babies with congenital malformations |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of early oral motor stimulation for promoting oral feeding in preterm infants admitted in NICU |
At discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of early oral motor stimulation on promoting oral feeding in preterm infants & to compare the efficacy of OMS in addition to NNS & KMC than NNS & KMC alone in reaching early oral feeding & breastfeeding |
At discharge |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
20/01/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Preterm babies fulfilling the inclusion criteria will be
enrolled in the study after obtaining written and informed consent from
parents. Every alternate baby enrolled will be assigned to group 1 and group 2
respectively. Group 1 babies will be receiving OMS along with NNS and KMC and
will constitute intervention group. Group 2 babies will be receiving only NNS and KMC and constitute control group. Mother will be trained by principal
investigator how to do oms several times till she will become confident. Oms
will be practiced by mother or the care giver 5 times a day before each feed
till the baby gets discharged or till breastfeeding will be achieved, hand
hygiene will also be taught to mother properly.
|