| CTRI Number |
CTRI/2021/12/038613 [Registered on: 14/12/2021] Trial Registered Prospectively |
| Last Modified On: |
13/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Early Versus Late Feeding in Preterm neonates with abnormal flow study on antenatal ultrasound scan |
|
Scientific Title of Study
|
Early Versus Late Feeding in Preterm neonates with Absent or Reversed End Diastolic Flow on Antenatal Umbilical Doppler studyâ€: A Randomized Controlled Trial |
| Trial Acronym |
ELFeeD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alpana Utture |
| Designation |
senior consultant |
| Affiliation |
Bai Jerbai Wadia HLospital for Children |
| Address |
Division of neonatology, 2nd floor, Bai Jerbai Wadia Hospital for Children, Acharya Donde marg , Parel, Mumbai
Division of neonatology, 2nd floor, Bai Jerbai Wadia hospital for Children,Acharya Donde marg , Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820042059 |
| Fax |
|
| Email |
utture.alpana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Astha Panghal |
| Designation |
DNB |
| Affiliation |
Bai Jerbai Wadia Hospital for Children |
| Address |
Division of neonatology, 2nd floor,Bai Jerbai Wadia hospital for Children, Acharya Donde marg , Parel, Mumbai
Division of Neonatology, 2nd floor, Bai Jerbai Wadia HLospital for Children, Acharya Donde marg , Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9654015228 |
| Fax |
|
| Email |
asthapanghal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alpana Utture |
| Designation |
senior consultant |
| Affiliation |
Bai Jerbai Wadia HLospital for Children |
| Address |
Division of neonatology, 2nd floor, Bai Jerbai Wadia Hospital for Children, Acharya Donde marg , Parel, Mumbai
Division of neonatology, 2nd floor, Bai Jerbai Wadia HLospital for Children,Acharya Donde marg , Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820042059 |
| Fax |
|
| Email |
utture.alpana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bai Jerbai Wadia Hospital for Children |
| Address |
Bai Jerbai Wadia Hospital for Children, Acharya Donde Marg, Parel, Mumbai, Maharashtra, 400012 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Alpana Utture |
Bai Jerbai Wadia Hospital for Children |
Division of Neonatology, 2nd floor, Bai Jerbai Wadia hospital for children, Acharya Donde Marg
Parel
Mumbai
MAHARASHTRA |
02224197200
utture.alpana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BJWHC IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: P018||Newborn affected by other maternalcomplications of pregnancy, (2) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
early feeding |
early feeding with mothers own milk or pasteurized donor human milk will be started within 24 hours of life as early as 6 hours @ 20ml per kg per day and increased daily by 20 ml per kg per day till bay reaches 150 ml/kg/day and sustain this volume for 3 days |
| Comparator Agent |
late feeding |
late feeding will start at 48 hours of life at 20ml per kg per day and remail same for next 48 hours and then increased by 20 ml per per day till baby reaches 150 ml/kg/day and sustain this volume for 3 dyas |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
Preterm babies with abnormal dopplers will be randomized within 6 hours of life |
|
| ExclusionCriteria |
| Details |
1. Neonates with major congenital malformations including gastrointestinal obstruction
2. Babies with known chromosomal abnormality or with dysmorphic features
3. Neonates with severe birth asphyxia (APGAR <4 at 5 min of life with cord/within 1 hour of life pH <7)
4. Twin to twin transfusion
5. Neonates requiring intrauterine transfusion or exchange transfusion
6. Significant multi-organ failure prior to trial entry
7. Inotropic support prior to trial entry
8. Already received any enteral feeding
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken to achieve full enteral feeds |
till the hospital stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of NEC
2. Day of regaining birthweight
3. Duration of Parenteral nutrition
4. Duration of hospitalization
5. Incidence of late onset sepsis
|
Till the hospital stay |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/12/2021 |
| 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="1"
Months="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is being conducted in preterm babies born with antenatal abnormal dopplers . After randomization these babies will be divided into two groups , early and late feeding groups and will be fed according to the protocol till they reach a full feeds of 150 ml per kg per day. during their hospital stay , babies will be monitored for signs of feed intolerance and action will be taken accordingly.Time taken to reach full feed will be taken as primary outcome . And ,incidence of NEC, day of regaining birthweight, duration of Parenteral nutrition, duration of hospitalization and incidence of late onset sepsis will be the secondary outcome.
|