The Effectiveness of Inhaled Salbutamol in the Management of Transient Tachypnea of the Newborn(TTN)

January 9, 2026 updated by: Tishreen University

TTN is the most common respiratory disorder in the perinatal period, causing 40% of cases of respiratory distress after birth. Lung fluid absorption is initiated by beta-adrenergic agonists, such as endogenous steroids and Catecholamine, which increase during labor. Delayed absorption of fluid from the lungs is thought to be the primary mechanism of transient tachypnea of the newborn (TTN). The accumulation of fluid within the lungs impairs gas exchange, leading to increased respiratory effort. Tachypnea develops to compensate for this, and hypoxemia develops due to impaired alveolar ventilation . The main objective of the study:

To study the effectiveness of salbutamol in improving signs of respiratory distress according to the modified Downes score during the first 72 hours of life in infants with transient tachypnea of the newborn (TTN). Secondary objectives:

Duration of tachypnea (time to resolution of respiratory distress) Reducing the duration of the need for oxygen support Reducing the length of hospital stay

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will be divided into two groups:

Intervention group B: receives a single dose of inhaled salbutamol at a dose of 0.15 mg/kg mixed with 2 ml of 0.9% normal saline.

Control group A: receives 2 ml of 0.9% normal saline. The study population consists of newborns born at Al-Ladhiqiyah University Hospital with a gestational age greater than 35 weeks who show signs of respiratory distress within the first 6 hours of birth.

Study Type

Interventional

Enrollment (Estimated)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Syria
    • Latakia Governorate
      • Latakia, Latakia Governorate, Syria

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Birth at the study hospital at a gestational age greater than 35 weeks. Clinical signs of TTN (tachypnea, retractions, grunting, nasal flaring) within the first 6 hours after birth.

-

Exclusion Criteria:

gestational age is 35 weeks or less. Meconium aspiration syndrome Pulmonary hypertension Congenital pneumonia and sepsis Congenital cardiovascular malformations Congenital thoracic and pulmonary malformations (diaphragmatic hernia, pulmonary hypoplasia, etc.)

-

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
Placebo Comparator: A control group
2 ml of 0.9% saline solution for inhalation
Drug: Normal Saline
normal saline by inhalation
Active Comparator: B intervention group
The patient receives a single dose of inhaled salbutamol at a dose of 0.15 mg/kg mixed with 2 ml of 0.9% normal saline.
Drug: Salbutamol (Albuterol)
It belongs to a class of medications known as short-acting beta-2 adrenergic agonist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
study on the effectiveness of salbutamol in improving respiratory distress signs according to the modified Downes score during the first 72 hours of life in infants with TTN.
Time Frame: 72 hours
Respiratory distress scores will be assessed using the modified Downes score ten minutes before the specified intervention is applied, and again at 6, 12, 24, 48, and 72 hours after the intervention begins.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tishreen University

Investigators

  • Study Chair: Adnan Dayoub, PHD, Tishreen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTN , newborn

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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