| CTRI Number |
CTRI/2024/05/066608 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of prophylactic supplementation of sodium on prevention of late onset sodium deficiency in neonates less than 32 weeks - A double blinded placebo randomised control trial |
|
Scientific Title of Study
|
Effect of prophylactic supplementation of sodium on prevention of late onset hyponatremia in neonates less than 32 weeks - A double blinded placebo randomised control 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 Amrutha Visalakshi S |
| Designation |
Senior Resident |
| Affiliation |
ABVIMS and RML hospital ,New Delhi |
| Address |
Dept of Neonatology
ABVIMS and RML hospital
New Delhi
9/2 first floor, South Patel Nagar ,New Delhi 110008
New Delhi
DELHI
110001
India |
| Phone |
9400615237 |
| Fax |
|
| Email |
amrutha94.v@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhawna Dubey |
| Designation |
Professor and head of department |
| Affiliation |
ABVIMS and RML hospital ,New Delhi |
| Address |
Dept of Neonatology
ABVIMS and RML hospital
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9811520862 |
| Fax |
|
| Email |
bhawnasd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrutha Visalakshi S |
| Designation |
Senior Resident |
| Affiliation |
ABVIMS and RML hospital ,New Delhi |
| Address |
Dept of Neonatology
ABVIMS and RML hospital
New Delhi
9/2 first floor, South Patel Nagar ,New Delhi 110008
New Delhi
DELHI
110001
India |
| Phone |
9400615237 |
| Fax |
|
| Email |
amrutha94.v@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr. RML hospital, New Delhi - 110001,India |
|
|
Primary Sponsor
|
| Name |
Dr Amrutha Visalakshi S |
| Address |
50/86, Lakshmi, P O Arakkinar, Kozhikode 673028, Kerala, India |
| Type of Sponsor |
Other [principal investigator] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ABVIMS and Dr RML Hospital |
New Delhi 110001, India |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amrutha Visalakshi S |
ABVIMS and Dr RML hospital |
inborn NICU,gate no.2 and outborn NICU,gate no. 5
Central
DELHI |
9400615237
amrutha94.v@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,ABVIMS,Dr. RML Hospital,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
hyponatremia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
supplementation of 3% saline solution |
supplementation of 3% saline solution as oral or IV to preterms less than 32 weeks starting between 4 -7 days of life till 34 weeks or till develops hypernatremia |
| Comparator Agent |
supplementation of sterile water |
supplementation of sterile water as oral or IV to preterms less than 32 weeks starting between 4 -7 days of life till 34 weeks or till develops hypernatremia |
|
|
Inclusion Criteria
|
| Age From |
4.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
Preterm Neonates less than 32 weeks of gestation admitted within 7 days of life at NICU of ABVIMS and Dr. RML Hospital, New Delhi with Serum sodium 130-145 mEq/L by postnatal day 4 |
|
| ExclusionCriteria |
| Details |
Presence of lethal congenital malformations or chromosomal abnormalities
Presence of AKI (defined as an S. Creatinine rise more than or equal to0.3 mg/dl within 48 h or urine output less than 0.5 (ml/kg/h) for 6–12 h)
Disease states (such as hydrops fetalis) that are characterized by edema- like hydrops fetalis, congestive heart failure within DOL 7
Refusal to consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of late onset hyponatremia among neonates less than 32 weeks given prophylactic sodium supplementation versus placebo |
incidence of late onset hyponatremia among neonates less than 32 weeks given prophylactic sodium supplementation versus placebo |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the effect of prophylactic sodium supplementation in preterm neonates less than 32 weeks on their postnatal weight gain, length & head circumference weekly till discharge
2. To study the effect of sodium supplementation on the incidence of adverse effects like feed intolerance, hypernatremia, reopening of patent ductus arteriosus (PDA) during study period till discharge
3. To see the rate of supplementation failure, i.e development of hyponatremia (S, Na less than 135 mEq/L ) in the supplemented group till period of supplementation
4. To study the incidence of systemic hypertension at discharge in both the groups
5. To compare the incidence of other prematurity related morbidities like late onset sepsis, chronic lung disease, NEC more than stage II, in-hospital mortality & duration of hospital stay in both the groups.
|
weekly till discharge & during the study period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/05/2024 |
| 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="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
|
EFFECT OF PROPHYLACTIC SUPPLEMENTATION OF SODIUM ON PREVENTION OF LATE ONSET HYPONATREMIA IN NEONATES <32 WEEKS: A DOUBLE BLINDED PLACEBO RANDOMISED CONTROLLED TRIAL
Purpose of the study Preterm infants have increased sodium intake requirements due to renal tubular immaturity and its deficiency is associated with significant morbidity. Currently there are no standard of care guidelines regarding how much and how long to supplement sodium in preterm infants to prevent late onset hyponatremia and thereby postnatal growth failure which is directly linked to the long-term neurodevelopmental outcome in this vulnerable population. Knowledge regarding the adverse events related to prophylactic supplementation of sodium is also limited. Good quality studies are lacking regarding sodium supplementation in prevention of late onset hyponatremia. Hypothesis of the trial
Prophylactic sodium supplementation in extreme and very preterm babies (< 32 weeks) decreases the incidence of late onset hyponatremia |