| CTRI Number |
CTRI/2017/11/010577 [Registered on: 21/11/2017] Trial Registered Prospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutrition] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of growth in VLBW neonates randomised to 2 hourly and 3 hourly feeding intervals |
|
Scientific Title of Study
|
A randomised control trial to compare growth velocity in VLBW neonates (1-1.5 kg) fed at 2 hourly and 3 hourly intervals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avadhesh Joshi |
| Designation |
Senior PG Registrar |
| Affiliation |
Christian Medical College |
| Address |
Dr. Avadhesh Joshi
Department of Neonatology, ISSCC building, CMC, Vellore
Tamil Nadu, India
Vellore TAMIL NADU 632004 India |
| Phone |
8890955794 |
| Fax |
|
| Email |
joshi.kmc@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Avadhesh Joshi |
| Designation |
Senior PG Registrar |
| Affiliation |
Christian Medical College |
| Address |
Dr. Avadhesh Joshi
Department of Neonatology, ISSCC building, CMC, Vellore
Tamil Nadu, India
Vellore TAMIL NADU 632004 India |
| Phone |
8890955794 |
| Fax |
|
| Email |
joshi.kmc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S Sridhar |
| Designation |
Professor & Head |
| Affiliation |
Christian Medical College |
| Address |
Department of Neonatology, ISSCC building, CMC, Vellore
Tamil Nadu, India
Vellore TAMIL NADU 632004 India |
| Phone |
|
| Fax |
|
| Email |
neonat@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| FLUID research grant, IRB, CMC Vellore |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Christian Medical College
Ida Scudder Road,
Vellore - 632004
Tamil Nadu, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Avadhesh Joshi |
Christian Medical College |
Department of Neonatology, ISSCC building, 3rd floor, CMC, Vellore Vellore TAMIL NADU |
8890955794
joshi.kmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Very low birth weight babies (1-1.5 kg), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 hourly feeding interval |
Babies will be given feed at 2 hourly interval till weight of baby reaches 1.8kg |
| Intervention |
3 hourly feeding interval |
Babies will be given feed at 3 hourly interval till weight of baby reaches 1.8kg |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
To compare weight gain velocity (gm/kg/day) in VLBW babies receiving 2 hourly v/s 3 hourly feeds |
|
| ExclusionCriteria |
| Details |
1) Infants with major congenital anomalies, surgical conditions, conditions where feed intolerance is anticipated.
2) Lack of Consent
3) Clinician decision regarding poor chances of survival
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare weight gain velocity (gm/kg/day) in VLBW babies receiving 2 hourly v/s 3 hourly feeds |
weight of baby 1.8kg |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Time to reach birth weight
2) Time to reach full feeds (200 ml/kg/day)
3) Incidence of feed intolerance, sepsis, probable sepsis, NEC, hypoglycaemia, hyperbilirubinemia, apnea
4) Duration of hospitalisation
5) Duration of phototherapy
6) Anthropometric measurements: head circumference velocity, length gain velocity
7) Duration of central venous lines and incidence of CLABSI
8) Total time spent by nurses on feeding
|
weight of baby 1.8kg |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2017 |
| Date of Study Completion (India) |
24/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
24/08/2019 |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Adequate nutrition plays an important role in survival, growth and development of preterm infants. Nutrition in preterm infants can be given via enteral or parenteral route. Parenteral route has complications of vascular catheterisation, sepsis, fasting and adverse effects of nutrition. The cost is also increased with use of TPN. Enteral feeding is also beneficial as it improves gastro-intestinal motility, increases release of gastro-intestinal hormones which have trophic effects and leads to decreased feed intolerance. Enteral feeding practices vary between different neonatal units. Preterm neonates have lack of co-ordination between sucking, swallowing and breathing hence gavage feeding is started. They are arbitrarily given bolus feeding at fixed intervals or given continuous feeds. Bolus feeding may be more physiological as it brings about more natural surges in intestinal hormones. Bolus feeding is also given at different intervals(1 hourly, 2 hourly, 3 hourly). There is no consensus on what feed interval to be followed in preterm VLBW infants. In our nursery, 2 hours feeding regimen is routinely followed with few babies being shifted to 1 hourly, 3 hourly or continuous feeds as per clinician’s decision. This study is designed to evaluate the weight gain velocity of babies receiving 3 hourly feeds as compared to 2 hourly feeds.
|