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Effectiveness of Salbutamol in treatment of TTNB- A RCT STUDY

A randomized controlled trial of the efficacy of inhaled salbutamol with standard therapy vs standard therapy alone for treatment of transient tachypnoea of newborn TTNB - NOT APPLICABLE

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057567
Enrollment
100
Registered
2023-09-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: J80- Acute respiratory distress syndrome

Interventions

Intervention1: Salbutamol: nebulization with salbutamol at rate of 0.15ml/kg/hour every 6 hours for a duration till resolution of symptoms or 120 hours whichever is longer. Control Intervention1: Norm

Sponsors

Department of pediatrics INHS ASVINI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: respiratory distress in NBB born within 6 hours of their birth

Exclusion criteria

Exclusion criteria: Gross congenital anomaly Neonates born through meconium stained liqour Any birth trauma Any h/o birth asphyxia ( APGAR score Neonatal sepsis Radiological finding consistent with pneumonia Presence of PPHN RDS of prematurity Metabolic disorder like dysglycemia

Design outcomes

Primary

MeasureTime frame
to observe any reduction of oxygen therapy duration in interventional group as compared to placebo groupTimepoint: Outcome will be assessed after intervention at an interval of every 30 min, 1 hour and then every 2 hour subsequently till resolution of symptoms

Secondary

MeasureTime frame
To observe reduction in hospital stay & early initiation of feedsTimepoint: To observe reduction in hospital stay from the baseline

Countries

India

Contacts

Public ContactDr Safquat Jalil

INSTITUTE OF NAVAL MEDICINE

drbhatvivek@gmail.com9592296155

Outcome results

None listed

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