Effectiveness of Salbutamol in treatment of TTNB- A RCT STUDY

Phase 2

Not yet recruiting

• Conditions: Acute respiratory distress syndrome,

• Registration Number: CTRI/2023/09/057567
• Lead Sponsor: Department of pediatrics INHS ASVINI

Brief Summary

NBB developing respiratory distress within 6 hours of birth, without any other comorbidities (exclusion criteria) will be diagnosed as TTNB and given standard treatment of TTNB. Among them half will be assigned intervention group which will be nebulization with salbutamol every 6 hourly and will assesed with DOWNE score and placebo group will be given nebulization with normal saline. Result will be tabulated on the basis duartion required to wean off from oxygen therapy

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-05-09
• Study Start: 2023-09-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

respiratory distress in NBB born within 6 hours of their birth.

Exclusion Criteria

Gross congenital anomaly Neonates born through meconium stained liqour Any birth trauma Any h/o birth asphyxia ( APGAR score < 6 at 1 min after birth) Neonatal sepsis Radiological finding consistent with pneumonia Presence of PPHN RDS of prematurity Metabolic disorder like dysglycemia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to observe any reduction of oxygen therapy duration in interventional group as compared to placebo group	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 Outcome Measures

Name	Time	Method
To observe reduction in hospital stay & early initiation of feeds	To observe reduction in hospital stay from the baseline

Trial Locations

Locations (1)

Neonatal intensive care unit; 🇮🇳 Mumbai, MAHARASHTRA, India

Neonatal intensive care unit

🇮🇳Mumbai, MAHARASHTRA, India

Dr Safquat Jalil

Principal investigator

9831046748

sj.ipgmer@gmail.com