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Effect of Nebulized Salbutamol in time taken to recover in Transient Tachypnea of newborn

Effect of Nebulized Salbutamol in treatment of Transient Tachypnea of Newborn: A Randomized placebo control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097695
Enrollment
100
Registered
2025-11-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: J99- Respiratory disorders in diseasesclassified elsewhere

Interventions

Intervention1: Nebulised Salbutamol: 0.15mg/kg/dose with 3ml NS with 6-8l O2 over 15-20mins Intervention2: Nil: Nil Control Intervention1: Normal saline: 0.15mg/kg/dose with 3ml NS with 6-8l O2 over 1

Sponsors

ICMR PG THESIS FUND
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Term neonates greater than 37 weeks gestation) 2.Age less than 6 hours 3.Clinical and radiological findings suggestive of TTNB as per Rawlings and smith which is based on the radiologic and clinical findings Clinically: 1. Early (within 6 hours of birth) onset of tachypnea 2. Persistence of tachypnea sometimes with retractions, or expiratory grunting and, occasionally, cyanosis that is relieved by minimal oxygen supplementation. 3. Chest generally sounds clear without rales or rhonchi. Chest radiograph shows: a. Prominent pulmonary vascular markings. b. Fluid in the interlobar fissure. c. Flat diaphragms and rarely pleural effusion. d. Hyperaeration 4. Term Neonates diagnosed with TTNB whose parents are willing for consent

Exclusion criteria

Exclusion criteria: 1.Preterm neonates less than 37 weeks of gestation 2.Major congenital anomalies of lung and heart 3.Perinatal asphyxia (Apgar less than 5 at 5 min) 4.Sepsis (Sepsis screening or culture-positive) 5.Meconium aspiration syndrome or other diagnosed cause of respiratory distress 6.Term Neonates diagnosed with TTNB whose parents are not willing for consent

Design outcomes

Primary

MeasureTime frame
We anticipate that Nebulized Salbutamol will significantly reduce the time taken to resolve TTN in term neonates and accelerate clinical improvement, thereby facilitating earlier discharge and decreasing NICU burden. Timepoint: At 24 hrs, 48 hrs and 72 hrs

Secondary

MeasureTime frame
1.Need for mechanical ventilation 2. Duration of NICU stay 3. Adverse effects Timepoint: At 24 hrs, 48hrs & 72 hrs

Countries

India

Contacts

Public ContactDr G Harinie

Trichy SRM Medical College Hospital And Research Center

muthuvelbalasubramaniyan@gmail.com6381054001

Outcome results

None listed

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