Inhaled Furosemide for Transient Tachypnea of Newborn

Overview

This is a randomized double blind clinical trial in which newborns with suspected Transient tachypnea of the newborn (TTN) will receive either furosemide or normal saline by nebulizer every 6 hours for 24 hours.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Other
  • Masking: Triple (Participant, Care Provider, Investigator)
• Study Primary Completion Date: August 1, 2021

Interventions

• Other: Furosemide
  • Patients will receive nebulised furosemide solution 1 mg/kg
• Other: Placebo
  • Patients will receive nebulised 0.9% saline

Arms, Groups and Cohorts

• Experimental: Furosemide
  • Patients will receive nebulised furosemide
• Placebo Comparator: Placebo
  • Patients will receive nebulised 0.9% saline

Clinical Trial Outcome Measures

Primary Measures

• Percentage of patients with respiratory morbidity
  • Time Frame: 24 hours
  • Neonatal respiratory morbidity will be assessed through oxygen saturation, respiratory rate and duration on Continuous positive airway pressure (CPAP)

Secondary Measures

• Length of hospital stay
  • Time Frame: 15 days
  • Duration of hospital stay in days

Participating in This Clinical Trial

Inclusion Criteria

• Neonates with 34+0-39+0 gestational age – on the first day of life – with the clinical diagnosis of Transient Tachypnoea – need for CPAP >6 hours to obtain the oxygen saturation >92% Exclusion Criteria:

• Systemic infection – Intubation and mechanical ventilation before Inclusion in the trail – Malformation and any other disease with disturb of respiratory system

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 1 Day

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Makassed General Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Mariam Rajab, Principal Investigator – Makassed General Hospital
• Overall Official(s)
  • Mariam Rajab, MD, Principal Investigator, Makassed General Hospital