| CTRI Number |
CTRI/2020/06/025958 [Registered on: 18/06/2020] Trial Registered Prospectively |
| Last Modified On: |
28/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparision between automated feeding and nurse led feeding in neonates |
|
Scientific Title of Study
|
Comparison of time taken for feeding stable preterm babies between regular nurse feeding and feeding with feed rail – Randomized control study |
| Trial Acronym |
Feed rail |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDeepti Thandaveshwara |
| Designation |
Assistant Professor |
| Affiliation |
JSS Medical College |
| Address |
Department of Pediatrics,JSS Medical College,Mysore
JSS Academy of Higher Education and Research,
Shivarathreeshwaranagar,
Mysore,Karnataka
Mysore
KARNATAKA
570015
India |
| Phone |
9845023309 |
| Fax |
|
| Email |
deeptiadarsh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDeepti Thandaveshwara |
| Designation |
Assistant Professor |
| Affiliation |
JSS Medical College |
| Address |
Department of Pediatrics,JSS Medical College,Mysore
JSS Academy of Higher Education and Research,
Shivarathreeshwaranagar,
Mysore,Karnataka
Mysore
KARNATAKA
570015
India |
| Phone |
9845023309 |
| Fax |
|
| Email |
deeptiadarsh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDeepti Thandaveshwara |
| Designation |
Assistant Professor |
| Affiliation |
JSS Medical College |
| Address |
Department of Pediatrics,JSS Medical College,Mysore
JSS Academy of Higher Education and Research,
Shivarathreeshwaranagar,
Mysore,Karnataka
Mysore
KARNATAKA
570015
India |
| Phone |
9845023309 |
| Fax |
|
| Email |
deeptiadarsh@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Academy of Higher Education and Research,Bannimantap Road,Shivarathreeshwaranagara,Bannimantap A Layout,Bannimantap,Mysore570015 |
|
|
Primary Sponsor
|
| Name |
JSS Academy of Higher Education and Research |
| Address |
Bannimantap Road, Sri Shivarathreeshwara Nagara, Bannimantap A Layout, Bannimantap, Mysuru, Karnataka 570015 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrDeepti Thandaveshwara |
Neonatal ICU, 2nd floor,JSS Hospital |
MG Road,Ramachandra Agrahara,Mysore,570004
Mysore
KARNATAKA |
9845023309
deeptiadarsh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,JSS Medical College,Mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Feed rail |
an automated feeding device is used to feed stable pretrem neonates and compare with the standard nasogastric feeding technique |
| Comparator Agent |
Nasogastric feeding |
In the control group, the prescribed volume of feeds was administered by the assigned nurse with the standard gravity feeding technique. The height of the syringe was paused at the level the nurse decides to be optimal milk flow rate. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Day(s) |
| Age To |
40.00 Day(s) |
| Gender |
Both |
| Details |
Babies weighing less than 2 kg, tolerating oral feeds and with at least 50% of their nutritional requirement through gavage were included in the study. |
|
| ExclusionCriteria |
| Details |
Sick neonates on ventilator and ionotropes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time taken and variation in feeding rate between automated feed rail and nurse led gravity feeding. |
At the end of each feeding event |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/06/2020 |
| Date of Study Completion (India) |
31/07/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
10. Thandaveshwara D, Krishnegowda S, Batra A, Doreswamy SM. Comparison of Time Taken for Feeding Stable Preterm Babies Between Regular Nurse Feeding and Feeding with Feed Rail-A Randomized, Controlled Study. Indian J Pediatr. 2022 Jan;89(1):19-24. doi: 10.1007/s12098-021-03770-0 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Feeding of preterm and low birth weight babies though often challenging can determine the survival and outcome of these babies. In a resource limited setting where the nurse baby ratio is often deviating from the prescribed , feeding the babies becomes a herculean task. The feeding time greatly varies with each nurse and baby pair. In order to achieve a slow, sustained and uniform rate of feeding we designed and tested an automated feeding device ‘Feed rail’. This study was conducted to compare the feeding rate and its variation between nurse led feeding and the ‘Feed rail’ device feeding when babies are fed in a group. |