- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03208894
Role of Salbutamol and Furosemide in TTN
July 5, 2017 updated by: arshad khushdil, Armed Forces Hospital, Pakistan
Role of Salbutamol and Furosemide in Transient Tachypnea of Newborn
to see the effects of slabutamol and IV furosemide in the treatment of transient tachypnea of newborn
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 68000
- Department of Pediatrics
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Rawalpindi, Punjab, Pakistan, 68000
- Military Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- all newborn babies with clinically diagnosed TTN
Exclusion Criteria:
- babies less than 34 weeks babies with congenital malformations and CHD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: with salbutamol
|
efficacy of salbutamol and furosemide in TTN
Other Names:
|
|
Experimental: with furosemide
|
efficacy of salbutamol and furosemide in TTN
Other Names:
|
|
Experimental: both furosemide and salbutamol
|
efficacy of salbutamol and furosemide in TTN
Other Names:
|
|
No Intervention: no inervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
duration of oxygen requiremment in neonates having TTN.
Time Frame: upto 6 months
|
neonates will be subjected to treatment with furosemide and sabutamol and the duration of oxygen dependecy will be assessed.
|
upto 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
May 30, 2017
Study Completion (Actual)
June 30, 2017
Study Registration Dates
First Submitted
July 1, 2017
First Submitted That Met QC Criteria
July 5, 2017
First Posted (Actual)
July 6, 2017
Study Record Updates
Last Update Posted (Actual)
July 6, 2017
Last Update Submitted That Met QC Criteria
July 5, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Infant, Newborn, Diseases
- Signs and Symptoms, Respiratory
- Infant, Premature, Diseases
- Respiratory Distress Syndrome, Newborn
- Respiratory Distress Syndrome
- Tachypnea
- Transient Tachypnea of the Newborn
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Potassium Chloride Symporter Inhibitors
- Furosemide
Other Study ID Numbers
- TTN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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