| CTRI Number |
CTRI/2021/03/031643 [Registered on: 01/03/2021] Trial Registered Prospectively |
| Last Modified On: |
30/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Related to Feeding] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of starting total versus minimal milk feeding in stable low birth weight babies born at or beyond 32 weeks gestation on the duration of hospital stay |
|
Scientific Title of Study
|
Comparison of initiating total enteral feeding versus incremental feeding since birth in stable very low birth weight and small for gestational age babies at or above 32 weeks of gestation on duration of hospital stay |
| Trial Acronym |
TEFILS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TANMESH KUMAR SAHU |
| Designation |
DM RESIDENT |
| Affiliation |
Lokmanya Tilak Municipal General Hospital And Medical College |
| Address |
HUMAN MILK BANK
DEPARTMENT OF NEONATOLOGY
LTMMC and GH
SION HOSPITAL
SION WEST MUMBAI
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7381850746 |
| Fax |
|
| Email |
tanmeshsahu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
TANMESH KUMAR SAHU |
| Designation |
DM RESIDENT |
| Affiliation |
Lokmanya Tilak Municipal General Hospital And Medical College |
| Address |
HUMAN MILK BANK
DEPARTMENT OF NEONATOLOGY
LTMMC and GH
SION HOSPITAL
SION WEST MUMBAI
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7381850746 |
| Fax |
|
| Email |
tanmeshsahu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Manerkar |
| Designation |
Additional professor |
| Affiliation |
Lokmanya Tilak Municipal General Hospital And Medical College |
| Address |
Department of Neonatology
L.T.M.M.C and L.T.M.G.H Sion, Mumbai
MAHARASHTRA
400022
INDIA
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9769997968 |
| Fax |
|
| Email |
drswatimanerkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal Medical college and General Hospital |
|
|
Primary Sponsor
|
| Name |
Lokmanya Tilak Municipal Medical college and General Hospital |
| Address |
L.T.M.M.C & G.H
Sion, Mumbai
Maharashtra
400022
400022 |
| Type of Sponsor |
Government 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 Swati Manerkar |
NICU |
Department of Neonatology
Lokmanya Tilak Municipal Medical College and General Hospital
Sion, Mumbai
400022
Mumbai
MAHARASHTRA |
9769997968
drswatimanerkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutuional Ethics Committee Human Research Lokmanya tilak municipal medical college and General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P071||Other low birth weight newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early Total Enteral Feeding group |
Babies shall receive total enteral feeding in the form of human milk (MOM/PDHM) (mothers own milk/ pasteurized donor human milk) within 2 hours of birth as gavage feeding and continued every 3hourly.The total volume of feeds given will as per total fluid requirements for the day of life. D1 feed of 80ml/kg/day, D2 100ml/kg/day D3 120 ml/kg/day D4 150 ml/kg/day and same volume to be continued for next 2 days to be defined as reaching full enteral feeds. Further increase in feed volume shall depend on treating physician. |
| Comparator Agent |
Incremental Feed Group |
Feeding shall be started with 20ml/kg/day of mothers own milk or donor human milk on Day 1 and the rest of fluids shall be administered as intravenous fluids through peripheral lines. On Day 2 40ml/kg of feeds, Day 3 60ml/kg of feeds, Day 4 90ml/kg of feeds , Day 5 120ml/kg/day and Day 6 150ml/kg/day. This feed volume shall be continued for next 2 days if tolerated. Further feed increase shall be as per treating physician. The total fluid intake shall be same as that of the intervention group for the respective day of life. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All very low birth weight and small for gestational age babies more than or equal to 32 weeks of gestation with ,Heart rate in between 100 to 180 beats/min, Respiratory rate in between 40 to 60/min, Axillary Temperature in between 36.5 to 37.5 degree C, Capillary filling time of < 3sec, Spo2 ( saturation of oxygen) in between 90 to 95%, BP (blood pressure), normal as per nomograms
|
|
| ExclusionCriteria |
| Details |
1. Requiring resuscitation beyond bag and mask ventilation for 30 seconds.
2. Major congenital anomalies
3. Babies with absent or reverse end diastolic flow in the Umbilical artery Doppler
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of hospital stay |
From day of admission to the day of discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Survival to hospital discharge
2.Number of episodes of Hypoglycemia
3.Number of episodes of feed intolerance
4.Incidence of NEC (Bell’s stage greater than or equal to 2) or Spontaneous intestinal perforation.
5. Time taken to achieve 150 ml/kg/d of feed and maintained for three consecutive days.
6.Number of microbiologically-confirmed or clinically suspected (defined by diagnostic criteria) late-onset sepsis until hospital discharge.
7. Time to regain birth weight in days
|
From admission to the discharge of the baby |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2021 |
| Date of Study Completion (India) |
29/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/01/2022 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to email tanmeshsahu@gmail.com
- For how long will this data be available start date provided 18-01-2023 and end date provided 18-01-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Very low birth weight refers to babies with birth weight in between 1000 to 1499gm. Initiation of enteral feeds for very-low-birth weight (VLBW) infants is often delayed for several days due to concerns about feeding intolerance and necrotizing enterocolitis (NEC). The intestine of small for gestational age neonate has reduced weight, length, wall thickness, villous weight and crypt depth. Pathophysiology of fetal adaptation to chronic hypoxia involves preferential shunting of blood to the brain at the expense of the splanchnic circulation. Earlier studies had very samples from the SGA populations. Early introduction of enteral feeds resulted in early achievement of full feeds and doesn’t appear to increase the risk of NEC. This delay diminishes the functional adaptation of the gastrointestinal tract and may prolong the duration of parenteral nutrition with its attendant infectious and metabolic risks. Early introduction and rapid advancement of enteral feeding in preterm infants improves gut maturity and thus reduces the risk of NEC. So the above study shall test the hypothesis that, early total enteral feeding in these group of babies shall lead to shorter duration of hospital stay and earlier discharge. |