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Prophylactic nasal continuous positive airways pressure in newborns of 28–31 weeks gestation: multicentre randomised controlled clinical trial

Abstract

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.

  • 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
  • nasal continuous positive airways pressure
  • prophylaxis
  • surfactant
  • respiratory distress syndrome
  • preterm newborn

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