NCT04397991

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

May 18, 2020

Last Update Submit

August 28, 2022

Conditions

Respiratory Morbidity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Length of hospital stay

    15 days

Study Arms (2)

Furosemide

EXPERIMENTAL

Patients will receive nebulised furosemide

Other: Furosemide

Placebo

PLACEBO COMPARATOR

Patients will receive nebulised 0.9% saline

Other: Placebo

Interventions

FurosemideOTHER

Patients will receive nebulised furosemide solution 1 mg/kg

Furosemide
PlaceboOTHER

Patients will receive nebulised 0.9% saline

Placebo

Eligibility Criteria

Age1 Day - 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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%

You may not qualify if:

  • Systemic infection
  • Malformation and any other disease with disturb of respiratory system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

MeSH Terms

Interventions

Furosemide

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Mariam Rajab, MD

    Makassed General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 21, 2020

Study Start

January 2, 2020

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

August 30, 2022

Record last verified: 2022-08

Locations

LE(1)