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

NCT07350421 | Not Yet Recruiting

• 1 other identifier: TTN , newborn
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

TTN

Keywords

TTN; newboen

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

A control group

PLACEBO COMPARATOR

2 ml of 0.9% saline solution for inhalation

Drug: Normal Saline

B intervention group

ACTIVE COMPARATOR

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)

Interventions

Salbutamol (Albuterol) DRUG

It belongs to a class of medications known as short-acting beta-2 adrenergic agonist.

B intervention group

Normal Saline DRUG

normal saline by inhalation

A control group

Eligibility Criteria

• Age: 1 Hour - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Latakia University

Latakia, Latakia Governorate, Syria

Location

Related Publications (1)

• Kim MJ, Yoo JH, Jung JA, Byun SY. The effects of inhaled albuterol in transient tachypnea of the newborn. Allergy Asthma Immunol Res. 2014 Mar;6(2):126-30. doi: 10.4168/aair.2014.6.2.126. Epub 2013 Nov 15.

  PMID: 24587948 RESULT

Related Links

• Effects of Salbutamol on the Treatment of Transient Tachypnea of the Newborn

MeSH Terms

Interventions

Albuterol; Saline Solution

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Adnan Dayoub, PHD

  Tishreen University

  STUDY CHAIR

Central Study Contacts

jawad thaer shhada, D.r

CONTACT

+963991861748; jawad.th.shahada@latakia-univ.edu.sy

Adnan Dayoub, PHD

CONTACT

+963968013111; Adnan.dayoub@latakia-univ.edu.sy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 20, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 20, 2026

Record last verified: 2025-10

Locations

SY (1)