| CTRI Number |
CTRI/2024/08/071821 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effects of Full Enteral Feeding since D1 of life versus Conventional Enteral Feeding in stable infants of 28 to 31 weeks of period of gestation- A Randomized Controlled Trial |
|
Scientific Title of Study
|
Early Total Enteral Feeding versus Conventional Enteral Feeding in stable very preterm infants 28+0 to 31+6 weeks of period of gestation 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 Madhurima Karak |
| Designation |
Junior Resident, Paediatrics |
| Affiliation |
Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, Kolkata |
| Address |
Department of Paediatrics Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, 99, Sarat Bose Road, Kolkata
99, Sarat Bose Road, Kolkata
Kolkata
WEST BENGAL
700026
India |
| Phone |
9434378070 |
| Fax |
|
| Email |
madhurimakarak36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tapabrata Chatterjee |
| Designation |
Professor and Head, Paediatrics |
| Affiliation |
Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, Kolkata |
| Address |
Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, 99, Sarat Bose Road, Kolkata
99, Sarat Bose Road, Kolkata
Kolkata
WEST BENGAL
700026
India |
| Phone |
9831213723 |
| Fax |
|
| Email |
tapo.chattopadhyay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhurima Karak |
| Designation |
Junior Resident, Paediatrics |
| Affiliation |
Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, Kolkata |
| Address |
Department of Paediatrics, Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, 99, Sarat Bose Road, Kolkata
99, Sarat Bose Road, Kolkata
Kolkata
WEST BENGAL
700026
India |
| Phone |
9434378070 |
| Fax |
|
| Email |
madhurimakarak36@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics,Ramakrishna Mission Seva Pratishthan, Vivekanada Institute of Medical Sciences,99 Sarat Bose Road, Kolkata 700026 |
|
|
Primary Sponsor
|
| Name |
Ramakrishna Mission Seva Pratishthan Vivekanada Institute of Medical Sciences Kolkata |
| Address |
99,Sarat Bose Road, Kolkata 700026 |
| 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 |
| Dr Madhurima Karak |
Ramakrishna Mission Seva Pratishthan, Kolkata |
Department of Paediatrics, 2nd Floor, 99, Sarat Bose Road, Kolkata 700026
Kolkata
WEST BENGAL |
9434378070
madhurimakarak36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, Ramakrishna Mission Seva Pratishthan, Kolkata |
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 |
| Comparator Agent |
Control Group (Conventional Enteral Feeding) |
Approximately 20 mL/kg/day enteral feed to be given 2 or 3 hourly to preterm infants since their D1 of life. Rest of the total fluid requirements will be in the form of intravenous fluid. Feed will be gradually advanced as per their tolerance till they get discharged from NICU |
| Intervention |
Trial Group (Early Total Enteral Feeding) |
According to Total Fluid Requirements, full enteral feed i.e. 80 mL/kg/day feed to be introduced to the preterm infants 2 or 3 hourly since D1 of life and gradually advanced till the time they get discharged from NICU |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1.Neonates of POG 28+0 to 31+6 weeks
2.Haemodynamically stable
3.Admitted in Inborn NICU |
|
| ExclusionCriteria |
| Details |
1. Babies with significant congenital anomalies
2. Less than 1 kg birth weight
3. Less than 28 weeks / more than 32 weeks POG
4. Babies with shock requiring inotropic support
5. APGAR score less than 5/10 at 10 min of life
6. significant hypoglycemia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postnatal age at attaining 150 mL/kg/day feed |
At the time of discharge from NICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Episodes of feed intolerance
2. Incidence of sepsis and necrotizing enterocolitis
3. Duration of hospital stay |
At the time of discharge from NICU |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
12/08/2024 |
| 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="0"
Months="6"
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
|
In this study, 28+0 to 31+6 weeker haemodynamically stable babies admitted at inborn NICU will be included. According to total fluid requirements, trial group will be introduced full enteral feed since D1 of life and the control group will be introduced 20 mL/kg/day enteral feed; whereas rest of the requirement will be met in the form of intravenous fluid. As per tolerance of feed of babies, feed will be advanced and primary outcome will be assessed in terms of postnatal age when 150 mL/kg/ day feed is reached. The two groups will be compared by means of episodes of feed intolerance, incidence of sepsis and necrotizing enterocolitis as well as duration of hospital stay. |