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A prospective study on Oral melatonin for MRI sedation in neonates and infants

Swaddle Vs Swaddle with oral melatonin for MRI in neonates and infants- A prospective randomised control study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072135
Enrollment
152
Registered
2024-08-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P09- Abnormal findings on neonatal screening Health Condition 2: Q070- Arnold-Chiari syndrome Health Condition 3: G00- Bacterial meningitis, not elsewhere classified Health Condition 4: G80- Cerebral palsy Health Condition 5: P942- Congenital hypotonia Health Condition 6: Q040- Congenital malformations of corpuscallosum Health Condition 7: P90- Convulsions of newborn Health Condition 8: G40- Epilepsy and recurrent seizures Health Condition 9: G91- Hydrocephalus Health Conditi

Interventions

Intervention1: 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 Control Intervention1: or

Sponsors

Dr Raylene Dias
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: weight more than 1.5 kilogram Term and Ex-preterm infants with post conceptional age more than 37 weeks

Exclusion criteria

Exclusion criteria: history of apneic episodes history of laryngomalacia or tracheomalacia hemodynamically unstable requirement of oxygen or ventilatory support MRCP

Design outcomes

Primary

MeasureTime frame
Was imaging successful without interruptions in first attempt? (Yes/No)Timepoint: T1- baseline T2- At end of procedure( 1 hour)

Secondary

MeasureTime frame
Adverse events during or after procedureTimepoint: T2- At end of procedure(1 hour);quality of imaging (grading 1-3)Timepoint: T2- At end of procedure(1 hour);Was imaging successful with interruptions? (Yes/No)Timepoint: T1- Baseline T2- At end of procedure( 1 hour)

Countries

India

Contacts

Public ContactDr Raylene Dias

Seth GS Medical college and KEM hospital

drgayathrip@gmail.com9848638850

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026