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Effect of salbutamol on neonatal transient tachypnea

Investigating the effect of inhaled salbutamol (Ventolin) in the improvement of the treatment of neonatal transient tachypnea

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250811066816N1
Enrollment
80
Registered
2025-08-28
Start date
2025-09-26
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transient Tachypnea of newborn. Transient tachypnea of newborn

Interventions

Intervention 1: intervention group: they will receive a single dose of inhaled salbutamol (Ventolin, manufactured by Cipla, India) at a dose of 0.15 milligram equivalent to 0.15 milliliter per kilogra

Sponsors

Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 28 Days

Inclusion criteria

Inclusion criteria: Neonates with gestational age at term, near-term, or post-term Presence of clinical manifestations and history suggestive of TTN At least one radiologic criterion of TTN, including:Pulmonary hyperinflationBilateral perihilar vascular prominenceFluid in the transverse fissureOr similar findings

Exclusion criteria

Exclusion criteria: History of meconium aspiration Respiratory distress syndrome (RDS) Congenital pneumonia Polycythemia Hypoglycemia Proven early-onset sepsis Congenital heart disease Tachycardia exceeding 180 beats per minute Cardiac arrhythmia Congenital anomalies

Design outcomes

Primary

MeasureTime frame
Respiratory distress score. Timepoint: Before treatment and after treatment at intervals of 30 minutes, one hour, and four hours. Method of measurement: This system is a clinical tool for assessing the severity of respiratory distress in neonates. It evaluates five main indicators: grunting, nasal flaring, xiphoid retraction, lower chest retraction, and upper chest retraction.Method of measurement: Each indicator is evaluated by direct clinical observation of a trained physician or nurse, including the presence or absence of sounds such as grunting with a stethoscope, assessment of nasal wing movements, and observation and palpation of chest wall movements in different regions during inspiration and expiration.Scoring system: For each of the five indicators, the severity of findings is scored from 0 to 2.Score 0: No sign or normal condition (for example, no grunting, no retraction).Score 1: Mild or minimal finding (for example, grunting audible with stethoscope, slight retraction or nasal flaring).Score 2: Clear or severe finding (for example, grunting audible without stethoscope, marked nasal flaring, severe chest retraction with see-saw breathing).Final interpretation: The total score ranges from 0 to 10. Lower scores indicate mild or absent respiratory distress, while higher scores represent more severe distress requiring further intervention.

Secondary

MeasureTime frame
Length of Hospital Stay. Timepoint: At admission and at discharge. Method of measurement: Based on the patient’s medical records.;Respiratory Rate. Timepoint: Before starting treatment, 30 minutes, one hour, and four hours after. Method of measurement: Counting the respiratory rate for one minute based on abdominal and chest movements of the neonate.;Heart rate. Timepoint: Before starting treatment, 30 minutes, one hour, and four hours after. Method of measurement: Based on pulse oximetry information.;Oxygen saturation. Timepoint: Before starting treatment, 30 minutes, one hour, and four hours after. Method of measurement: Based on pulse oximetry information.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Mahdi Foruhari

Kashan University of Medical Sciences

M.Forouhari@kaums.ac.ir+98 31 5544 2015

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026