| CTRI Number |
CTRI/2025/07/092126 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Oro-motor exercises along with non nutritive sucking is being given to preterm neonates ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Does Adding Pacifier Sucking to Mouth Exercises Help Preterm Babies Start Full Feeding Faster?
|
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Scientific Title of Study
|
Efficacy of Oromotor Stimulation and Non Nutritive Sucking vs Non Nutritive Sucking alone on Transition from Gavage to Full Oral Feeding in Preterm Neonates: A 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 |
Ritika Agrawal |
| Designation |
Junior Resident |
| Affiliation |
N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital |
| Address |
N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA
Nagpur
MAHARASHTRA
440016
India |
| Phone |
7083114563 |
| Fax |
|
| Email |
ritikaagrawal111196@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anjali Edbor |
| Designation |
Professor |
| Affiliation |
N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital |
| Address |
N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA
Nagpur
MAHARASHTRA
440016
India |
| Phone |
9822470808 |
| Fax |
|
| Email |
dranjaliedbor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ritika Agrawal |
| Designation |
Junior Resident |
| Affiliation |
N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital |
| Address |
N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA
Nagpur
MAHARASHTRA
440016
India |
| Phone |
7083114563 |
| Fax |
|
| Email |
ritikaagrawal111196@gmail.com |
|
|
Source of Monetary or Material Support
|
| N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA |
|
|
Primary Sponsor
|
| Name |
Ritika Agrawal |
| Address |
N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA |
| 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 |
| Dr Ritika Agrawal |
N.K.P. Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital |
Pediatrics Deprtment, Neonatal Intensive Care Unit
Nagpur
MAHARASHTRA |
7083114563
ritikaagrawal111196@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| N.K.P. Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Nagpur |
Approved |
|
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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 |
| Comparator Agent |
Non Nutritive Sucking |
Neonates in the comparator group will be given oral motor intervention for 5 minutes according to the program proposed by Fucile et al. (which is not followed by Non Nutritive Sucking) 3 times a day at an interval of 6 hours till the baby achieves Complete Oral Feed. |
| Intervention |
Oromotor Stimulation and Non Nutritive Sucking |
Neonates in the intervention group will be given oral motor intervention for 5 minutes according to the program proposed by Fucile et al. followed by non-nutritive sucking for 8-10 minutes; 3 times a day at an interval of 6 hours till the baby achieves Complete Oral Feed. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
90.00 Day(s) |
| Gender |
Both |
| Details |
Preterm Neonates admitted in NICU.
Preterm Neonates having stable vital signs and have been started with total gavage feeding. |
|
| ExclusionCriteria |
| Details |
Preterm Neonates who are haemodynamically unstable
Preterm Neonates having facial oral congenital anomaly.
Preterm Neonates without their mothers |
|
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Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Oromotor Stimulation and Non Nutritive Sucking with Non Nutritive Sucking alone with respect to number of days taken for transition from gavage feeding to full oral feeding in Preterm Neonates. |
Time of delivery will be taken as day 1 and duration in days of transition from gavage to full oral feeding will be taken into consideration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Oromotor Stimulation and Non Nutritive Sucking with Non Nutritive Sucking alone with respect to weight gain in Preterm Neonates |
Time of delivery will be taken as day 1 and the neonate will be weighed daily till the transition from gavage to full oral feeding |
|
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Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/09/2025 |
| 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="2"
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
|
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Brief Summary
|
Fifteen million preterm babies are born each year, and because of their weak oral muscles and uncoordinated sucking and swallowing reflexes, they are at a significant risk of developing feeding problems orally. Non-nutritive sucking (NNS) is used in preterm newborns to improve the development of sucking behavior and enhance their ability to digest enteral feedings. It is also utilized during gavage feeding and during the transition from gavage to breast or bottle feeding. A randomized clinical trial had previously investigated the impact of oral motor therapy on non-nutritive sucking (NNS), oral stimulation (OS), and the combination NNS/OS intervention. The results showed that NNS alone increased sucking pressure during oral feeding and shortened the transition time from gavage feeding to complete oral feeding. In preterm neonates oromotor stimulation along with routine care reduces the duration of gavage feeding as compared to routine care alone. Oral motor intervention combined with non-nutritive sucking can significantly improve the oral motor ability of premature newborns, promote the process of oral feeding, improve the outcome of oral feeding, and reduce the occurrence of adverse effects. The preterm infants who received oral motor stimulation transited to full oral feeding earlier and showed a higher success in sucking. Some studies shows that the OMS with NNS is showing significant outcomes as compared to NNS alone. On the other hand, in literature review inconsistent data were reported regarding the impact of NNS with OS on functional swallowing outcomes, including a negative effect on weight gain. Therefore, the aim of the present study was to explore the clinical effectiveness of oral motor intervention combined with NNS on premature infants in comparison with NNS alone. |