| CTRI Number |
CTRI/2024/05/067912 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [we are using a very small dose of enteral insulin as it has a gut modulatory effect. ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Oral Insulin on Time to Reach Full Enteral Feeding in Preterm Infants less than 32 weeks of gestation and less than 1250 gram: A randomised controlled trial |
|
Scientific Title of Study
|
Effect of Enteral Insulin on Time to Reach Full Enteral Feeding in Preterm Infants ≤ 32 weeks and ≤ 1250 grams: A Randomised 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 |
Dr Neelam Kler |
| Designation |
MD Pediatrics |
| Affiliation |
Sir Gangaram Hospital, NewDelhi |
| Address |
Professor and Chairperson, Department of neonatology, Sir Gangaram Hospital, NewDelhi
Central
DELHI
110060
India |
| Phone |
9811047391 |
| Fax |
|
| Email |
drneelamkler@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Kler |
| Designation |
MD Pediatrics |
| Affiliation |
Sir Gangaram Hospital, NewDelhi |
| Address |
Professor and Chairperson, Department of Neonatology, Sir Gangaram Hospital, New Delhi
DELHI
110060
India |
| Phone |
9811047391 |
| Fax |
|
| Email |
drneelamkler@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhuri Jhanwar |
| Designation |
DrNB Neonatology, PG student |
| Affiliation |
sir gangaram hospital |
| Address |
Department of Neonatology, Sir Gangaram Hospital, New Delhi
Department of Neonatology, Sir Gangaram Hospital, New Delhi
Central
DELHI
110060
India |
| Phone |
09579841066 |
| Fax |
|
| Email |
jhawar66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Gangaram Hospital, New Delhi, India, 110060 |
|
|
Primary Sponsor
|
| Name |
Dr Neelam Kler |
| Address |
Department of Neonatology, Sir Gangaram hospital, NewDelhi |
| Type of Sponsor |
Other [self] |
|
|
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 Madhuri Jhanwar |
Sir Gangaram Hospital , NewDelhi |
Neonatal intensive care unit, Department of Neonatology
Central
DELHI |
9579841066
jhawar66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Sir Gangaram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
preterm infants born ≤ 32 weeks and ≤ 1250 grams |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Insulin |
Everyday NICU Incharge will prepare a stock solution of insulin in 10 ml syringe by diltuing 1ml of regular insulin solution with 9 ml normal saline making strength of 4 units/ml. Desired dose of insulin 1 unit/kg (0.25 ml/kg) of the stock solution will be withdrawn in 1 ml syringe and will be given to enrolled infants under intervention arm along with feeds every 6 hourly. Sugar monitoring will be done as per predecided protocol. Intervention will be given for a total of 28 days or till discharge whichever is earlier |
| Comparator Agent |
Normal saline |
0.25 ml/kg of normal saline will be given with feeds every 6 hourly under placebo arm. It will be given for a total of 28 days or till discharge whichever is earlier |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
preterm infants ≤ 32 weeks of gestation and ≤ 1250 gram in whom enteral feed is being initiated |
|
| ExclusionCriteria |
| Details |
gestational age less than 26 weeks or birth weight less than 500 gram suspected GI malformations maternal diabetes hypoglycemia requiring glucose administration of more than 12mg/kg/min in first 72 hours of life failure to obtain consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to reach full enteral feeding defined as total enteral intake of 180 ml/kg/day tolerated for 48 hours |
Day of life when baby reaches feeds to 180 ml/kg/day which baby has tolerated for 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken to reach enteral intake of 100 ml/kg/day tolerated for 48 hours
Duration of parenteral nutrition
Episodes of feeding intolerance
Duration of NPO hours
Time taken to regain birth weight
Incidence of culture positive sepsis
Incidence of necrotising enterocolitis stage 2 or more
Episodes of hypoglycemia
Growth velocity at stoppage of intervention & at discharge
Change in z scores from birth till stoppage of intervention & at discharge for weight length & head circumference Duration of hospital stay
All cause mortality |
Day of life when baby reaches feeds of 100ml/kg/day tolerated for 48 hours
At discharge |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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 3 |
|
Date of First Enrollment (India)
|
04/06/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a randomised controlled trial to study the effect of enteral insulin on time to reach full enteral feeding in preterm infants ≤ 32 weeks and ≤ 1250 grams. Preterm infants have an immature gut, reduced digestive capacity and poor intestinal motility. This leads to an increase in the time to reach full enteral feeding, thereby increasing the duration of parenteral nutrition, length of hospital stay and risk of sepsis. insulin present in breast milk is known to have a beneficial influence on maturation of gut. Insulin when supplemented orally, has a local effect on gut mucosa and helps in enterocyte proliferation, increased enzyme activity and improved absoprtive capacity of gut. Two randomised controlled trials on enteral insulin have reported benefits in terms of decreased time to reach full enteral feeding, improved feeding tolerance and decrease in duration of parenteral nutrition. These benefits could further translate in reduction in rates of sepsis and other PN associated complications. this can have important implications in the developing countries where this strategy has not been studied. we plan to conduct a randomised controlled trial to study the effect of enteral insulin on time to reach full enteral feeding in preterm infants ≤ 32 weeks gestation and ≤ 1250 gram birth weight. eligible infants will be randomly allocated into two groups, Group A (enteral insulin group) and group B (placebo group). we hypothesize that enteral insulin therapy compared to placebo will decrease time to reach full enteral feeding in preterm infants ≤ 32 weeks gestation and ≤ 1250 gram birth weight by 2.5 days. Our primary objective is to compare the time to reach full enteral feeding defined as feeding volume of 180 ml/kg/day tolerated for 48 hours, in enteral versus placebo group. Our secondary objectives are time to reach enteral intake of 100ml/kg/day, duration of parenteral nutrition, episodes of feeding intolerance, time taken to regain birth weight, incidence of culture positive sepsis, incidence of necrotising enterocolitis, episodes of hypoglycemia, growth velocity at stoppage of intervention and at discharge for weight, length and head circumference, duration of hospital stay and all cause mortality
|