¹ Institute of Neonatology, University of Bologna, Bologna, Italy
² Division of Neonatology, San Gerardo Hospital, Monza, Italy
³ Department of Neonatology, Clinica Mangiagalli, ICP, Milano, Italy
⁴ Division of Neonatology, Ospedali Riuniti, Foggia, Italy
⁵ Division of Neonatology, Bianchi Melacrino Morelli Hospital, Reggio Calabria, Italy
⁶ Division of Neonatology, Policlinico S Matteo, Pavia, Italy
⁷ Department of Medical and Surgical Neonatology, Bambino Gesù Children’s Hospital, Rome, Italy

Correspondence to:
Correspondence to:
Dr Sandri
Istituto di Neonatologia, Via Massarenti, 11 40138 Bologna, Italy; sandri{at}med.unibo.it

Background: The role of nasal continuous positive airways pressure (nCPAP) in the management of respiratory distress syndrome in preterm infants is not completely defined.

Objective: To evaluate the benefits and risks of prophylactic nCPAP in infants of 28–31 weeks gestation.

Design: Multicentre randomised controlled clinical trial.

Setting: Seventeen Italian neonatal intensive care units.

Patients: A total of 230 newborns of 28–31 weeks gestation, not intubated in the delivery room and without major malformations, were randomly assigned to prophylactic or rescue nCPAP.

Interventions: Prophylactic nCPAP was started within 30 minutes of birth, irrespective of oxygen requirement and clinical status. Rescue nCPAP was started when FIO₂ requirement was > 0.4, for more than 30 minutes, to maintain transcutaneous oxygen saturation between 93% and 96%. Exogenous surfactant was given when FIO₂ requirement was > 0.4 in nCPAP in the presence of radiological signs of respiratory distress syndrome.

Main outcome measures: Primary end point: need for exogenous surfactant. Secondary end points: need for mechanical ventilation and incidence of air leaks.

Results: Surfactant was needed by 22.6% in the prophylaxis group and 21.7% in the rescue group. Mechanical ventilation was required by 12.2% in both the prophylaxis and rescue group. The incidence of air leaks was 2.6% in both groups. More than 80% of both groups had received prenatal steroids.

Conclusions: In newborns of 28–31 weeks gestation, there is no greater benefit in giving prophylactic nCPAP than in starting nCPAP when the oxygen requirement increases to a FIO₂ > 0.4.

Abbreviations: CPAP, continuous positive airways pressure; FIO₂, fraction of inspired oxygen; MV, mechanical ventilation; nCPAP, nasal continuous positive airways pressure; RDS, respiratory distress syndrome; SpO₂, transcutaneous oxygen saturation

Keywords: nasal continuous positive airways pressure; prophylaxis; surfactant; respiratory distress syndrome; preterm newborn

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