Clinical trial NCT05527704: the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)
Official title: a Multicentre, Double-blind, Randomized, Placebo-controlled Phase III Trial of the Inhaled β2-adrenergic Receptor Agonist Salbutamol for Transient Tachypnoea of the Newborn (the REFSAL Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: TTN
Respiratory Failure
PPHN
Keywords: TTN
PPHN
CPAP
Salbutamol
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: University of Ottawa
name: Jagiellonian University
name: Pomeranian Medical University Szczecin
name: Poznan University of Medical Sciences
name: Jan Biziel University Hospital No 2 in Bydgoszcz
name: Neonatology Unit, Specialist Hospital No 2, Bytom
name: University of Rzeszow
name: University in Zielona Góra
First posted: 2022-09-02
Enrollment: 608
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Persistent Pulmonary Hypertension of the Newborn (PPHN)
timeFrame: 7 days of life
Secondary outcomes:
measure: the severity of respiratory distress
timeFrame: 48 hrs of life
measure: need for intubation
timeFrame: 7 days of life
measure: duration of ventilation
timeFrame: 7 days of life
measure: duration of hospitalization
timeFrame: up to first month of life
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Renata Bokiniec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: