NCT03208894

Brief Summary

to see the effects of slabutamol and IV furosemide in the treatment of transient tachypnea of newborn

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

July 1, 2017

Last Update Submit

July 5, 2017

Conditions

Transient Tachypnea of the Newborn

Outcome Measures

Primary Outcomes (1)

  • 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.

    upto 6 months

Study Arms (4)

with salbutamol

EXPERIMENTAL
Drug: Furosemide Injection

with furosemide

EXPERIMENTAL
Drug: Furosemide Injection

both furosemide and salbutamol

EXPERIMENTAL
Drug: Furosemide Injection

no inervention

NO INTERVENTION

Interventions

Furosemide InjectionDRUG

efficacy of salbutamol and furosemide in TTN

Also known as: salbutamol inhalation
both furosemide and salbutamolwith furosemidewith salbutamol

Eligibility Criteria

Age1 Hour - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all newborn babies with clinically diagnosed TTN

You may not qualify if:

  • babies less than 34 weeks babies with congenital malformations and CHD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Pediatrics

Rawalpindi, Punjab Province, 68000, Pakistan

Location

Military Hospital

Rawalpindi, Punjab Province, 68000, Pakistan

Location

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, NewbornRespiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersTachypneaInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CONCULTANT PEDIATRICIAN

Study Record Dates

First Submitted

July 1, 2017

First Posted

July 6, 2017

Study Start

November 1, 2016

Primary Completion

May 30, 2017

Study Completion

June 30, 2017

Last Updated

July 6, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)