Respiratory Morbidity Clinical Trial
Official title:
Inhaled Furosemide for Transient Tachypnea of Newborn
| NCT number | NCT04397991 |
| Other study ID # | 18122018 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2, 2020 |
| Est. completion date | August 1, 2021 |
| Verified date | August 2022 |
| Source | Makassed General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | August 1, 2021 |
| Est. primary completion date | August 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Day to 1 Day |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Lebanon | Makassed General Hospital | Beirut |
| Lead Sponsor | Collaborator |
|---|---|
| Makassed General Hospital |
Lebanon,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of patients with respiratory morbidity | Neonatal respiratory morbidity will be assessed through oxygen saturation, respiratory rate and duration on Continuous positive airway pressure (CPAP) | 24 hours | |
| Secondary | Length of hospital stay | Duration of hospital stay in days | 15 days |
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