Back to resultsRole of Salbutamol and Furosemide in TTN
Primary Purpose
Transient Tachypnea of the Newborn
Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Furosemide Injection
Sponsored by
About this trial
This is an interventional treatment trial for Transient Tachypnea of the Newborn
Eligibility Criteria
Inclusion Criteria:
- all newborn babies with clinically diagnosed TTN
Exclusion Criteria:
- babies less than 34 weeks babies with congenital malformations and CHD
Sites / Locations
- Department of Pediatrics
- Military Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
with salbutamol
with furosemide
both furosemide and salbutamol
no inervention
Arm Description
Outcomes
Primary Outcome Measures
duration of oxygen requiremment in neonates having TTN.
neonates will be subjected to treatment with furosemide and sabutamol and the duration of oxygen dependecy will be assessed.
Secondary Outcome Measures
Full Information
NCT ID
NCT03208894
First Posted
July 1, 2017
Last Updated
July 5, 2017
Sponsor
Armed Forces Hospital, Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT03208894
Brief Title
Role of Salbutamol and Furosemide in TTN
Official Title
Role of Salbutamol and Furosemide in Transient Tachypnea of Newborn
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Forces Hospital, Pakistan
4. Oversight
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
5. Study Description
Brief Summary
to see the effects of slabutamol and IV furosemide in the treatment of transient tachypnea of newborn
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Tachypnea of the Newborn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
with salbutamol
Arm Type
Experimental
Arm Title
with furosemide
Arm Type
Experimental
Arm Title
both furosemide and salbutamol
Arm Type
Experimental
Arm Title
no inervention
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Furosemide Injection
Other Intervention Name(s)
salbutamol inhalation
Intervention Description
efficacy of salbutamol and furosemide in TTN
Primary Outcome Measure Information:
Title
duration of oxygen requiremment in neonates having TTN.
Description
neonates will be subjected to treatment with furosemide and sabutamol and the duration of oxygen dependecy will be assessed.
Time Frame
upto 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all newborn babies with clinically diagnosed TTN
Exclusion Criteria:
babies less than 34 weeks babies with congenital malformations and CHD
Facility Information:
Facility Name
Department of Pediatrics
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
68000
Country
Pakistan
Facility Name
Military Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
68000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Role of Salbutamol and Furosemide in TTN
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