NCT06921291

Brief Summary

Role of Salbutamol in the management of transient tachypnea of the new born

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2024

Shorter than P25 for phase_1

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

August 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

March 27, 2025

Last Update Submit

April 3, 2025

Conditions

TTN

Outcome Measures

Primary Outcomes (1)

  • Salbutamol nebulization improved transient tachypnea of the new born compared to normal saline nebulization alone.

    Two study groups ,one using Salbutamol nebulization and other using normal saline nebulization . The one group with Salbutamol nebulization improved a lot than the group using normal saline nebulization. The study was conducted in Khyber Teaching Hospital Peshawar neonatal unit .

    4 months

Study Arms (1)

Role of Salbutamol in the management of transient tachypnea of the new born

EXPERIMENTAL

Salbutamol treatment compared to normal saline in patients with transient tachypnea of the new born

Drug: Salbutamol (Ventolin®)

Interventions

Salbutamol (Ventolin®)DRUG

Randomized controlled trials

Role of Salbutamol in the management of transient tachypnea of the new born

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Neonates with transient tachypnea

You may not qualify if:

  • age above 28 days
  • Other diseases than transient tachypnea of the new born

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Teaching Hospital Peshawar Pakistan

Timergara, KPK, 18300, Pakistan

Location

Related Links

MeSH Terms

Interventions

Albuterol

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Sabahat Amir, MBBS FCPS

    Department of Pediatrics Khyber Teaching Hospital Peshawar, KPK , Pakistan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Randomized controlled trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor, pediatrics specialist

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 10, 2025

Study Start

August 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Role of Salbutamol nebulization in improving transient tachypnea of the new born as compared to using normal saline nebulization alone .

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
From April 02, 2015 to December 31 ,2025.
Access Criteria
All other researchers are able to access this article, through this clinical trials.gov website.
More information

Locations

PA(1)