Active — Not RecruitingPhase 3

the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)

Poland608 participantsStarted 2021-12-31

Plain-language 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).

Who can participate

Age range24 Hours

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Gestational age at birth between 32 and 42 weeks.
✓. 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.
✓. Available chest radiographs obtained within six hrs after birth.
✓. 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

✕. 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).
✕. Multiple apnea-brady that require immediate intubation before a trial of NIV
✕. Age \>24 h.
✕. Meconium aspiration syndrome.
✕. Air leak syndrome.
✕. Congenital heart disease.
✕. Congenital diaphragmatic hernia.
✕. Other severe congenital malformations and genetic disorders (diagnosed before and after birth) associated with increased risk of respiratory failure.

What they're measuring

Persistent Pulmonary Hypertension of the Newborn (PPHN)

Timeframe: 7 days of life

Trial details

NCT IDNCT05527704

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30

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