| CTRI Number |
CTRI/2017/03/008156 [Registered on: 20/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
02/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to determine the efficacy of restricted fluid administration in improving health of babies who have brain injury due to less oxygen during birth. |
|
Scientific Title of Study
|
Fluid restriction for term infants with hypoxic- ischaemic encephalopathy following perinatal asphyxia-a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Nanavati |
| Designation |
Professor and head of the Department |
| Affiliation |
Seth G.S.Medical College and KEM hospital Mumbai |
| Address |
Department of Neonatology
ward 38
new building 10th floor
Seth G.S medical college and KEM hospital
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820127317 |
| Fax |
|
| Email |
drruchinanavati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anitha Ananthan |
| Designation |
Assistant Professor |
| Affiliation |
Seth G.S.Medical College and KEM hospital Mumbai |
| Address |
Department of Neonatology
ward 38
new building 10th floor
Seth G.S medical college and KEM hospital
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769660870 |
| Fax |
|
| Email |
ani.gem81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anitha Ananthan |
| Designation |
Assistant Professor |
| Affiliation |
Seth G.S.Medical College and KEM hospital Mumbai |
| Address |
Department of Neonatology
ward 38
new building 10th floor
Seth G.S medical college and KEM hospital
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769660870 |
| Fax |
|
| Email |
ani.gem81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Diamond Jubilee Society Trust,Old building first floor,Seth.G.S.medical college and KEM hospital,Mumbai,parel 400012 |
|
|
Primary Sponsor
|
| Name |
Diamond Jubilee Society Trust |
| Address |
Old building 1st floor
Seth G.S.Medical College and KEM hospital,Parel,Mumbai
400012 |
| Type of Sponsor |
Research institution |
|
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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 |
| Ruchi Nanavati |
Department of Neonatology,KEM hospital,Mumbai |
ward no: 38,new building 10th floor,Neonatal tertiary ICU,KEM Hospital,Mumbai
Mumbai
MAHARASHTRA |
9820127317
drruchinanavati@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, Neonates with perinatal asphyxia, (2) ICD-10 Condition: P039||Newborn affected by complication of labor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal maintenance intravenous fluid |
fluid at the rate 60
80
100
120
140
150 ml/Kg/day
This intervention is given for 6 days |
| Intervention |
restricted fluid |
newborn will be given less amount of total intravenous fluids during the first 6 days
in ml/Kg/day
45
60
75
90
105
120
The total duration of intervention is 6 days. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
neonate with perinatal asphyxia |
|
| ExclusionCriteria |
| Details |
neonate with congenital malformation |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOME: Neonatal mortality or severe neurodevelopmental disability at discharge.
|
at discharge.
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1)electrolyte disturbances
2)Urine output1ml/kg/h during the first three days of life.
3)Abnormal renal function after the first 24 hours of life as a reflection of the asphyxia insult .
4)Seizures requiring anticonvulsants: detection of seizures based on either clinical grounds,detection by electroencephalogram, or by treatment of seizures with antiepilectic treatment.
5) CT or MRI changes consistent with asphyxia
|
electrolytes on day 1 and day 2
urine output on day 1,2 and 3
Renal function on day 2
seizures during admission(day 1-7)
MRI at discharge
|
|
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Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
Final Enrollment numbers achieved (Total)= "210"
Final Enrollment numbers achieved (India)="210" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
03/04/2017 |
| Date of Study Completion (India) |
15/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/12/2022 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Perinatal asphyxia and associated hypoxic ischaemic encephalopathy is an importnat cause of perinatally acquired brain damage in term infants.the rationale of fluid restriction in perinatal asphyxia is to avoid fluid overload and exacerbation of cerebral oedema.Restriction of fluid intake in cases of perinatal asphyxia is being practiced with experience in children and adults and animal experiments.Hence quantitative recommendation for fluid restriction cannot be obtained from above studies.
We aim to study the effct of fluid restriction in term infants with perinatal asphyxia on neurological outcomes.Primary outcomes to be measured are neonatal mortality or severe neurodevelopmental disability at discharge.the secondary outcomes to be measured include electrolyte imbalance,oliguria,abnormal renal function,seizures and CT/MRI findings consistent with asphyxia.This is a randomized controlled trial to be completed over a period of 2 years with 210 study participants with perinatal asphyxia.
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