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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05527704
Other study ID # 2019/ABM/01/00058/P/03
Secondary ID 2020-003913-36
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 31, 2021
Est. completion date September 30, 2026

Study information

Verified date September 2023
Source Medical University of Warsaw
Contact Renata Bokiniec, MD, PhD, Assoc Prof
Phone +48225966155
Email renata.bokiniec@wum.edu.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Clinical trial evaluating the efficacy and safety of salbutamol for the treatment of neonates with a gestational age between 32 and 42 weeks with transient tachypnoea of the newborn (TTN).


Description:

Multicentre, double-blind, phase III trial will include infants with a gestational age between 32 and 42 weeks and respiratory disorders treated in neonatal intensive care units in Poland. Infants will be enrolled no later than 24 h after birth and will be randomly assigned (1:1) to receive nebulized salbutamol with nCPAP or placebo (nebulized 0.9% NaCl) with nCPAP. The primary outcome is the percentage of infants with TTN who develop PPHN.


Recruitment information / eligibility

Status Recruiting
Enrollment 608
Est. completion date September 30, 2026
Est. primary completion date November 30, 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 24 Hours
Eligibility Inclusion Criteria: 1. Gestational age at birth between 32 and 42 weeks. 2. Respiratory disorders (tachypnea and expiratory grunting) lasting longer than 15 minutes after birth, or present for at least 15 minutes in the first six hrs of life, or a need for non-invasive respiratory support between birth and six hrs of life. 3. Available chest radiographs obtained within six hrs after birth. 4. Available parameters of the acid-base balance (blood pH, partial pressure of O2 and CO2, base excess) and blood serum ionogram for Na+, K+, Ca2+ evaluated in the umbilical cord blood sample. Exclusion Criteria: 1. Need for intubation directly after birth or perinatal asphyxia, defined as abnormal acid-base parameters detected in an umbilical cord blood sample (pH <7.0 or base excess < -14 mmol/L). 2. Multiple apnea-brady that require immediate intubation before a trial of NIV 3. Age >24 h. 4. Meconium aspiration syndrome. 5. Air leak syndrome. 6. Congenital heart disease. 7. Congenital diaphragmatic hernia. 8. Other severe congenital malformations and genetic disorders (diagnosed before and after birth) associated with increased risk of respiratory failure. 9. The need for a surfactant administration immediately after birth, regardless of the method of its administration (respiratory distress syndrome - RDS)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Salbutamol
Patients assigned to the active group will be treated with 0.15 mg/kg body weight (diluted in 3 mL 0.9% NaCl) nebulized salbutamol (Ventolin®, GlaxoSmithKline, Dublin, Ireland) for 30 min.
0,9% Chloride Sodium
3 mL nebulized 0.9% NaCl administered for 30 min.

Locations

Country Name City State
Poland Medical University of Warsaw Warsaw

Sponsors (9)

Lead Sponsor Collaborator
Medical University of Warsaw Jagiellonian University, Jan Biziel University Hospital No 2 in Bydgoszcz, Neonatology Unit, Specialist Hospital No 2, Bytom, Pomeranian Medical University Szczecin, Poznan University of Medical Sciences, University in Zielona Góra, University of Ottawa, University of Rzeszow

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Persistent Pulmonary Hypertension of the Newborn (PPHN) PPHN defined as the need for ventilation with FiO2 >0.30 and features of increased pulmonary pressure on echocardiogram 7 days of life
Secondary the severity of respiratory distress assessed with the modified TTN Silverman score 48 hrs of life
Secondary need for intubation frequency of need for intubation 7 days of life
Secondary duration of ventilation duration of ventilation e.g. non-invasive ventilation 7 days of life
Secondary duration of hospitalization duration of hospitalisation after birth up to first month of life
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