| CTRI Number |
CTRI/2024/10/075801 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the impact of high-volume feeds on weight gain in preterm infants less than 1500 grams in a special newborn care unit |
|
Scientific Title of Study
|
High (180 ml/kg) versus standard (150 to 160 ml/kg) volume feeding among preterm very low birth weight infants in a tertiary level SNCU - 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 |
Sunpreet Kaur |
| Designation |
Junior Resident |
| Affiliation |
Guru Gobind Singh Medical college and hospital faridkot , Punjab |
| Address |
Department of paediatrics Guru gobind singh medical college and hospital faridkot , Punjab
Department of paediatrics Guru gobind singh medical college and hospital faridkot , Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
8685827742 |
| Fax |
|
| Email |
sunpreetkaur3110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amanpreet Sethi |
| Designation |
Associate professor Neonatolgy |
| Affiliation |
Guru Gobind Singh Medical college and hospital faridkot , Punjab |
| Address |
Department of paediatrics Guru Gobind Singh Medical college and hospital faridkot , Punjab
Department of paediatrics Guru gobind singh medical college and hospital faridkot, punjab
Faridkot
PUNJAB
151203
India |
| Phone |
7011371669 |
| Fax |
|
| Email |
sethi.amanpreet702@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amanpreet Sethi |
| Designation |
Associate professor Neonatolgy |
| Affiliation |
Guru Gobind Singh Medical college and hospital faridkot , Punjab |
| Address |
Department of pediatrics Guru Gobind Singh medical college and hospital Faridkot , Punjab
Department of pediatrics Guru Gobind Singh medical college and hospital Faridkot, Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
7011371669 |
| Fax |
|
| Email |
sethi.amanpreet702@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatrics Guru Gobind Singh Medical College and hospital, Faridkot,151203, Punjab, India
|
|
|
Primary Sponsor
|
| Name |
Department of pediatrics Guru Gobind Singh medical college and hospital Faridkot |
| Address |
G medical college faridkot , punjab |
| 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 Sunpreet Kaur |
Guru gobind singh medical college faridkot punjab |
Specialized Newborn Care Unit ,Fist floor ,Department of paediatrics, in MCH block
Faridkot
PUNJAB |
08685827742
sunpreetkaur3110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Guru Gobind Singh Medical College ,Faridkot ,Punjab Institutional ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
preterm very low birth weight infants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High volume feed group |
feeds will be increased gradually @20-30 ml/kg/day till
maximum 200 ml/kg/day is achieved and monitored till discahrge or 40 weeks of corrected gestational age whichever comes earlier |
| Comparator Agent |
Standard volume feeds group |
neonate will continue to receive 150-160 ml/kg/day. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Preterm neonates having birth weight less than or equal to 1500gm with postnatal age less than 14 days
Both inborn and out-born neonates will be enrolled
Baby should be hemodynamically stable and have achieved feeding volume of at least 100ml/kg/day. |
|
| ExclusionCriteria |
| Details |
Hemodynamically significant patent duct arteriosus.
Any Necrotizing enterocolitis at admission.
Known Congenital neuro-malformations or gastrointestinal malformation
Suspected Chromosomal anomalies.
6. Refusal of consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the growth velocity weight in gram per kg per day in very low birth weight neonates fed with standard versus high volume feeds. |
weight will be measured daily and weekly weight gain will be measured |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the other anthropometric measures viz length & head
circumference, & postnatal growth failure among these two groups.
3. To compare complications such as feed intolerance & necrotizing enterocolitis
stage two or more & chronic lung disease among these two groups |
These will be measured at birth then at enrollment & after it
weekly |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
11/11/2024 |
| 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="1"
Months="6"
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
|
Postnatal growth of very low birth weight neonates is a very important aspect of their management. Prevalence of postnatal growth restriction in preterm as well as low birth weight neonates is quite high at time of discharge and matter of concern. A metanalysis of studies comparing high versus standard volume enteral feeds in preterm and low birth weight infants conducted in 2021 concluded that high volume feeds, more than 180 ml per kg improve weight gain during hospital stay. The available data were inadequate to compare other anthropometric parameters or adverse outcomes in preterm very low birth weight fed with high volume versus standard volume enteral feeds. They concluded that further studies are needed on the subject. Therefore, we planned this randomized controlled trial to compare study high volume versus standard volume feeds in very low birth weight infants. |