| CTRI Number |
CTRI/2024/08/072135 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A prospective study on Oral melatonin for MRI sedation in neonates and infants |
|
Scientific Title of Study
|
Swaddle Vs Swaddle with oral melatonin for MRI in neonates and infants- A prospective randomised control study |
| 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 Raylene Dias |
| Designation |
Assistant professor |
| Affiliation |
Seth GS Medical college and KEM hospital |
| Address |
Department of Paediatric Anaesthesia, 3rd floor, KEM Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9930608191 |
| Fax |
|
| Email |
raylene.dias@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Gayathri |
| Designation |
Senior Resident |
| Affiliation |
Seth GS Medical college and KEM hospital |
| Address |
Department of Paediatric Anaesthesia, 3rd floor, KEM Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9848638850 |
| Fax |
|
| Email |
drgayathrip@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raylene Dias |
| Designation |
Assistant professor |
| Affiliation |
Seth GS Medical college and KEM hospital |
| Address |
Department of Paediatric Anaesthesia, 3rd floor, KEM Hospital
MAHARASHTRA
400012
India |
| Phone |
9930608191 |
| Fax |
|
| Email |
raylene.dias@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Development Fund
Department of paediatric anaesthesia,Seth GS Medical college and KEM Hospital, Mumbai-400012 |
|
|
Primary Sponsor
|
| Name |
Dr Raylene Dias |
| Address |
Department of Paediatric Anaesthesia, 3rd floor, KEM Hospital,Mumbai-400012 |
| 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 Raylene Dias |
KEM hospital |
Department of Paediatric Anaesthesia, 3rd floor, KEM Hospital
Mumbai
MAHARASHTRA |
09930608191
raylene.dias@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC)-1 for clinical trial, Bioavailability and bioequivalence study and relating to biomedical and health research(BHR), Seth GS Medical college and KEM Hospital, Mumbai, Maharashtra, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q030||Malformations of aqueduct of Sylvius, (2) ICD-10 Condition: Q02||Microcephaly, (3) ICD-10 Condition: Q040||Congenital malformations of corpuscallosum, (4) ICD-10 Condition: Q070||Arnold-Chiari syndrome, (5) ICD-10 Condition: P90||Convulsions of newborn, (6) ICD-10 Condition: P916||Hypoxic ischemic encephalopathy [HIE], (7) ICD-10 Condition: P942||Congenital hypotonia, (8) ICD-10 Condition: P912||Neonatal cerebral leukomalacia, (9) ICD-10 Condition: P09||Abnormal findings on neonatal screening, (10) ICD-10 Condition: G822||Paraplegia, (11) ICD-10 Condition: G00||Bacterial meningitis, not elsewhere classified, (12) ICD-10 Condition: G03||Meningitis due to other and unspecified causes, (13) ICD-10 Condition: G06||Intracranial and intraspinal abscess and granuloma, (14) ICD-10 Condition: G09||Sequelae of inflammatory diseasesof central nervous system, (15) ICD-10 Condition: G40||Epilepsy and recurrent seizures, (16) ICD-10 Condition: G45||Transient cerebral ischemic attacks and related syndromes, (17) ICD-10 Condition: G80||Cerebral palsy, (18) ICD-10 Condition: G91||Hydrocephalus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
oral 25% Dextrose |
oral dextrose is given 1 ml/kg 30 minutes prior to diagnostic MRI procedure |
| Intervention |
oral melatonin |
oral melatonin 1 ml/kg(pulverised melatonin added in 25% dextrose to get 1mg/ml solution) is given 30 minutes prior to diagnostic MRI procedure |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
weight more than 1.5 kilogram
Term and Ex-preterm infants with post conceptional age more than 37 weeks |
|
| ExclusionCriteria |
| Details |
history of apneic episodes
history of laryngomalacia or tracheomalacia
hemodynamically unstable
requirement of oxygen or ventilatory support
MRCP
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Was imaging successful without interruptions in first attempt? (Yes/No) |
T1- baseline
T2- At end of procedure( 1 hour) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Was imaging successful with interruptions? (Yes/No) |
T1- Baseline
T2- At end of procedure( 1 hour) |
| quality of imaging (grading 1-3) |
T2- At end of procedure(1 hour) |
| Adverse events during or after procedure |
T2- At end of procedure(1 hour) |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
Final Enrollment numbers achieved (Total)= "152"
Final Enrollment numbers achieved (India)="152" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2024 |
| Date of Study Completion (India) |
11/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
MRI(Magnetic resonance imaging) in neonates and infants requires immobility, which most often requires administration of anaesthesia with associated risks of neurotoxicity and airway manipulations. Swaddling technique provides immobility to some extent and which can be further improved by oral melatonin producing natural sleep. The patients will be prospectively enrolled and will be randomised to one o0f the 2 groups- Group M and Group S. All neonates/ infants are sleep and feed deprived for 4 hours prior to the imaging. In Group M the subject will receive 1ml/kg of melatonin (3mg tablet pulverized and added to 3 ml of 25 % dextrose) and in Group S the subject receives 1ml/kg of 25 % Dextrose 60 minutes prior the scan. Both groups receive breast feed 30 minutes prior and wrapped in a warm mattress and ears are plugged. Intravenous line tubing extension and pulseoximeter probe cable are made accessible after wrapping. Preprocedural(T1) and post procedural(T2) Heart rate, oxygen saturation and respiratory rate are noted. The subject Age, Post conceptional age,Diagnosis, MRI region scanned, Total MRI sequence time, Total time spent in Scan room, whether contrast was administered, Did the child move?, was the scan done with/ without interruption? Quality of image as reported by radiologist( graded 1-good; 2-compromised but reportable; 3-poor and not reportable. Any adverse events like apnea, aspiration, desaturation will be noted. The subject is awakened once the MRI is done. |