| CTRI Number |
CTRI/2024/07/070434 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [prophylactic use of Glycerin enema versus Glycerin suppository versus no intervention] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study the effect of use of prophylactic Glycerin enema versus Glycerin suppository versus no intervention on time required to reach full feeds in very low birth weight neonates |
|
Scientific Title of Study
|
An open-label randomized controlled trial to compare the time to reach full enteral feeds between the use of prophylactic Glycerin enema and Glycerin suppository and standard of care in neonates less than 1500 grams at birth |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasoon Bansal |
| Designation |
DM, senior resident |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
NICU, second floor, Bharati Hospital, Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
7620432218 |
| Fax |
|
| Email |
prasoonb999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandini Malshe |
| Designation |
Professor, daprtment of neonatology, Bharati vidyapeeth deemed to be university, Pune |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
NICU, second floor, Bharati Hospital, Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
9822850716 |
| Fax |
|
| Email |
malshenandini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prasoon Bansal |
| Designation |
DM, senior resident |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
NICU, second floor, Bharati Hospital, Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
7620432218 |
| Fax |
|
| Email |
prasoonb999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed University Medical College
Dhankwadi,Pune, India- 411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed University Medical College Pune |
| Address |
NICU, second floor, Bharati Hospital and research Centre, Dhankawadi, Pune, India 411043 |
| 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 Prasoon Bansal |
Bharati hospital and research Centre, Pune |
NICU , second floor, Hospital building, Bharati hospital and research Centre, Dhankawadi Pune, India - 411043
Pune
MAHARASHTRA |
7620432218
prasoonb999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed University Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Glycerin enema |
1st arm of neonates will be prophylactically administered glycerin enema using 6 Fr infant feeding tube inserted upto 6 cm in rectum starting at 24 hours of life and monitored time to reach full enteral feeds |
| Intervention |
Glycerin suppository |
2nd arm of neonates will be prophylactically administered 1 gram Glycerin suppository divided vertically in half starting at 24 hours of life and monitored for time to reach full enteral feeds |
| Comparator Agent |
no intervention (standard of care) |
3rd arm of neonates will not be given any intervention and monitored for time to reach full enteral feeds |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
neonates admitted to neonatal intensive care unit (NICU) on day-1 of life with birthweight less than 1500 grams at birth. |
|
| ExclusionCriteria |
| Details |
1)Congenital anomalies
2)Major surgery within 48 h of birth.
3)Neonate with APGAR less than 7 at 5 minutes of life.
4)Hemodynamically unstable neonate- e.g those requiring inotrope support |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The time (in days) required to achieve full enteral feeds (enteral feed volume of 150 ml/kg/day
for atleast 24 hours) between the use of prophylactic glycerin enema, glycerin suppository with
standard of care in neonates less than 1500 grams at birth. |
The time (in days) required to achieve full enteral feeds (enteral feed volume of 150 ml/kg/day
for atleast 24 hours) between the use of prophylactic glycerin enema, glycerin suppository with
standard of care in neonates less than 1500 grams at birth. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To compare time required to regain birth weight between the use of prophylactic glycerin
enema, glycerin suppository with standard of care in neonates less than 1500 grams at
birth.
2)To compare adverse events like feeding intolerance, necrotizing enterocolitis (Modified
Bell’s classification) between the use of prophylactic glycerin enema, glycerin
suppository with standard of care in neonates less than 1500 grams at birth.
3)To compare age at the time of discharge from hospital between the use of prophylactic
glycerin enema, glycerin suppository with standard of care in neonates less than 1500
grams at birth. |
1)time required to regain birth weight
2) time till discharge from NICU
3)time till discharge from NICU |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/07/2024 |
| 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
|
Enteral nutrition optimization in Very Low Birthweight neonates is challenging due to feed intolerance. Delayed meconium passage is more common in more premature infants, leading to obstructed deep intestinal segments and a delay in achieving full feeds.Glycerin laxatives stimulate passage of meconium by acting as an osmotic dehydrating agent and increasing osmotic pressure in the gut; they stimulate rectal contraction, potentially reducing the incidence of feeding intolerance.The Glycerin laxatives are among the commonly used strategies in preterm infants to treat or prevent feeding intolerance and to facilitate normal stooling pattern. However the evidence on the use of Glycerin laxatives in promoting feeding tolerance is limited. In this study, we aim to do a three-arm randomized controlled trial to compare the efficacy of Glycerin enema versus Glycerin suppository versus standard of care in reducing the time to reach full enteral feeds in neonates less than 1500 grams at birth. We hypothesize that there would be no difference in time to reach full enteral feeds in either of the study groups. |