| CTRI Number |
CTRI/2026/02/102715 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
01/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Feeding] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Randomized Controlled Trial Comparing Continuous, Standard Bolus, and Accelerated Continuous Enteral Feeding in Neonates Weighing Less Than 1.8 kg |
|
Scientific Title of Study
|
A Three-Arm, Parallel-Group Randomized Controlled Trial Comparing Continuous, Standard Bolus, and Accelerated Continuous Enteral Feeding in Neonates with Birth Weight less than 1.8 kg |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KRITI SHOKEEN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MGM MEDICAL COLLEGE, AURANGABAD, MAHARASHTRA |
| Address |
Department of Pediatrics, Neonatal Intensive Care Unit (NICU),
MGM Medical College and Hospital,
Chhatrapati Sambhajinagar, Maharashtra, India
Department of Pediatrics, Neonatal Intensive Care Unit (NICU),
MGM Medical College and Hospital,
Chhatrapati Sambhajinagar, Maharashtra, India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7768907662 |
| Fax |
|
| Email |
SHOKEENKRITI2698@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
KRITI SHOKEEN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MGM MEDICAL COLLEGE, AURANGABAD, MAHARASHTRA |
| Address |
Department of Pediatrics, Neonatal Intensive Care Unit (NICU),
MGM Medical College and Hospital,
Chhatrapati Sambhajinagar, Maharashtra, India
Department of Pediatrics, Neonatal Intensive Care Unit (NICU),
MGM Medical College and Hospital,
Chhatrapati Sambhajinagar, Maharashtra, India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7768907662 |
| Fax |
|
| Email |
SHOKEENKRITI2698@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
KRITI SHOKEEN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MGM MEDICAL COLLEGE, AURANGABAD, MAHARASHTRA |
| Address |
Department of Pediatrics, Neonatal Intensive Care Unit (NICU),
MGM Medical College and Hospital,
Chhatrapati Sambhajinagar, Maharashtra, India
Department of Pediatrics, Neonatal Intensive Care Unit (NICU),
MGM Medical College and Hospital,
Chhatrapati Sambhajinagar, Maharashtra, India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7768907662 |
| Fax |
|
| Email |
SHOKEENKRITI2698@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KRITI SHOKEEN |
| Address |
MGM Medical College and Hospital,
Department of Pediatrics,
Chhatrapati Sambhajinagar, Maharashtra,India |
| 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 KRITI SHOKEEN |
MGM MEDICAL COLLEGE AND HOSPITAL, NICU |
Department of Pediatrics, Neonatal Intensive Care Unit (NICU),
MGM Medical College and Hospital,
Chhatrapati Sambhajinagar, Maharashtra, India
Aurangabad
MAHARASHTRA |
7768907662
SHOKEENKRITI2698@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Mission’s Ethics Committee for Research on Human Subjects (MGM-ECRHS) |
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 |
Arm 1 Continuous Enteral Feeding Arm |
Arm 1: Continuous Enteral Feeding Neonates weighing less than 1.8 kg will receive continuous enteral feeding via nasogastric tube using a feeding pump over 24 hours. Feeding will be initiated at 10 ml/kg/day and advanced by 20 ml/kg/day until full enteral feeds of 150 ml/kg/day are achieved. Expressed breast milk will be used as per unit protocol. Neonates will be monitored daily for feeding tolerance, growth parameters, and complications. |
| Intervention |
Arm 2 Standard Bolus Enteral Feeding |
Arm 2: Standard Bolus Enteral Feeding Neonates weighing less than 1.8 kg will receive intermittent bolus enteral feeds via nasogastric tube at regular intervals as per unit protocol. Feeding will be initiated at 10 ml/kg/day and advanced by 20 ml/kg/day until full enteral feeds of 150 ml/kg/day are achieved. Expressed breast milk will be used. Monitoring will include feeding tolerance, anthropometry, and adverse events. (Note: CTRI prefers avoiding exact hourly wording unless necessary — “intermittent bolus” is acceptable and standard) |
| Intervention |
Arm 3
Accelerated Continuous Enteral Feeding |
Arm 3: Accelerated Continuous Enteral Feeding
Neonates weighing less than 1.8 kg will receive continuous enteral feeding via nasogastric tube using a feeding pump. Feeding will be initiated at 10 ml/kg/day and advanced at an accelerated rate of 30 ml/kg/day until full enteral feeds of 150 ml/kg/day are achieved. Expressed breast milk will be used. Neonates will be closely monitored for feeding intolerance and complications. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates with a birth weight less than 1.8kg eligible for nasogastric (NG)feeding admitted in
NICU
hemodynamically stable and eligible to start enteral feeding as per unit protocol |
|
| ExclusionCriteria |
| Details |
Major congenital anomalies, particularly gastrointestinal anomalies
Severe perinatal asphyxia
Conditions contraindicating enteral feeding (e.g., necrotizing enterocolitis at baseline) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time (in days) to achieve full enteral feeds (150 ml/kg/day) across the three feeding regimens |
Assessed daily from initiation of enteral feeding until achievement of full enteral feeds (150 ml/kg/day) or till discharge, whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary:
1. To compare the rate of weight gain (g/kg/day) among neonates receiving the three feeding regimens.
2. To look for development of complications Necrotizing enterocolitis, incidence of apnoea, any incidence of Sepsis)
3. To assess the length of hospital stay among the groups |
1- Assessed daily during hospital stay until discharge or attainment of full enteral feeds.
2-Assessed throughout the hospital stay until discharge.
3-Recorded at the time of Discharge |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
25/06/2026 |
| 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
|
|
Brief Summary
|
Low birth weight neonates often experience feeding intolerance and delayed achievement of full enteral nutrition due to gastrointestinal immaturity. Various enteral feeding strategies such as continuous and bolus feeding are practiced, but there is limited evidence regarding the optimal feeding method for neonates weighing less than 1.8 kg.
This study is a single-center, randomized controlled trial conducted in a tertiary care neonatal intensive care unit to compare continuous enteral feeding, standard bolus feeding, and accelerated continuous feeding in neonates weighing less than 1.8 kg. Eligible, hemodynamically stable neonates will be randomized into one of the three feeding groups. Enteral feeds will be initiated and advanced as per predefined protocols using expressed breast milk.
The primary outcome is the time taken to achieve full enteral feeds (150 ml/kg/day). Secondary outcomes include growth parameters, incidence of necrotizing enterocolitis, apnea, sepsis, and length of hospital stay. The findings of this study aim to identify the safest and most effective enteral feeding strategy for low birth weight neonates and guide evidence-based clinical practice. |