| CTRI Number |
CTRI/2024/08/072147 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [sodium supplementation of newborn ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of early oral sodium supplementation on growth of preterm neonates |
|
Scientific Title of Study
|
Impact of early oral sodium supplementation on growth of preterm neonates- 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 |
Rishu Kumar |
| Designation |
PG STUDENT |
| Affiliation |
NEOTIA GETWEL MULTISPECIALITY HOSPITAL |
| Address |
PAEDIATRIC DEPARTMENT, NEOTIA GETWEL MULTISPECIALITY HOSPITAL,BEHIND CITY CENTRE ,UTTORAYAN,MATIGARA,SILIGURI
Darjiling
WEST BENGAL
734010
India |
| Phone |
9693413685 |
| Fax |
|
| Email |
kumarrishu583@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NOOPUR BAIJAL |
| Designation |
CONSULTANT |
| Affiliation |
NEOTIA GETWEL MULTISPECIALITY HOSPITAL |
| Address |
NEOTIA GETWEL MULTISPECIALITY HOSPITAL,BEHIND CITY CENTRE ,UTTORAYAN,MATIGARA,SILIGURI
Darjiling
WEST BENGAL
734010
India |
| Phone |
9560798835 |
| Fax |
|
| Email |
doc_noopur@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Rishu Kumar |
| Designation |
PG STUDENT |
| Affiliation |
NEOTIA GETWEL MULTISPECIALITY HOSPITAL |
| Address |
NEOTIA GETWEL MULTISPECIALITY HOSPITAL,BEHIND CITY CENTRE ,UTTORAYAN,MATIGARA,SILIGURI,734010
Darjiling
WEST BENGAL
734010
India |
| Phone |
09693413685 |
| Fax |
|
| Email |
kumarrishu583@gmail.com |
|
|
Source of Monetary or Material Support
|
| NEOTIA GETWEL MULTISPECIALITY HOSPITAL, SILIGURI, WEST BENGAL- |
|
|
Primary Sponsor
|
| Name |
NEOTIA GETWEL MULTISPECIALITY HOSPITAL |
| Address |
NEOTIA GETWEL MULTISPECIALITY HOSPITAL,BEHIND CITY CENTRE ,UTTORAYAN,MATIGARA,SILIGURI,WEST BENGAL |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 RISHU KUMAR |
NICU,NEOTIA GETWEL MULTISPECIALITY HOSPITAL |
PAEDIATRIC DEPARTMENT, NICU DIVISON,DISCUSSION ROOM
Darjiling
WEST BENGAL |
09693413685
kumarrishu583@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee neotia getwel healthcare centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P071||Other low birth weight newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early oral sodium supplementation when their serum sodium value is 130-135 meq/l |
Supplementing oral sodium to preterm neonates in the form of 3 % ns With starting dose of 4 meq/kg/day for 7 days |
| Comparator Agent |
Oral sodium supplementation if serum sodium less 130 meq/l |
Comparator group receive standard therapy which means receives oral sodium supplementation with dose of 4 meq/kg/day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
7.00 Day(s) |
| Age To |
20.00 Day(s) |
| Gender |
Both |
| Details |
Preterm neonates less than 32 weeks or Birth Weight less than 1.5 kg with Serum sodium value is 130-135 meq/l |
|
| ExclusionCriteria |
| Details |
Severe Hyponatremia at onset of study less than 130 meq/l, Transfer to other institute, Critically ill requiring more than 50 % intravenous fluid in second week of life, Congenital Malformation, Hydrops Foetalis, Significant Oedema, Renal Failure, Consent Refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight Gain after 1 week of sodium supplementation |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary- Head Circumference(z Score and absolute value),Length
Length (z Score and absolute value),Development of Oedema, Duration of respiratory support, Development of Necrotising Enterocolitis or Spontaneous intestinal Perforation, Development of intraventricular hemorrhage or periventricular Leucomalacia
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
20/08/2024 |
| 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="0"
Months="6"
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
|
TITLE - IMPACT OF EARLY ORAL SODIUM SUPPLEMENTATION ON GROWTH OF PRETERM NEONATES– A RANDOMISED CONTROL TRIAL CONSENT- Parents or legally acceptable representive (LAR) of newborns meeting the eligibility criteria will approached for informed consent. An information sheet providing the detail of the study will be provided to Parents/LAR. They are free to decide to take part in study by signing a consent form. Even after they are still free to withdraw anytime without giving us any reason. ENROLLMENT- Preterm < 32 weeks or weight < 1.5 kg and Serum sodium 130-135 meq/l after 7 days . All eligible neonates will be randomised into two groups (group A and group B) by computer generated randomisation. Group A neonates receives oral sodium supplementation as 3%NaCl while group B receive standard therapy. In standard therapy neonates receives oral sodium supplementation if serum sodium less 130 meq/l . . Both Group A and Group B neonates will be monitored for serum sodium after every 3 days. Increament or decreament of dose depends on baby serum sodium value. Primary Objective- weight gain after 1 week of sodium supplementation. Secondary Objective - 1. Head circumference (z score or absolute value) 2. Length ( z score or absolute value) 3. Weight at discharge ( z score or absolute value) 4. Development of Oedema 5. Duration of respiratory support (CPAP, HFNC, Nasal Prong oxygen support) 6. Development of Necrotizing Enterocolitis or Spontaneous intestinal perforation 7. Development of Intraventricular Hemorrhage or Periventricular Leucomalacia at 28 days of life
|