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

Arch Dis Child Fetal Neonatal Ed. 2004 Sep;89(5):F394-8. doi: 10.1136/adc.2003.037010.

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Continuous Positive Airway Pressure / adverse effects
  • Continuous Positive Airway Pressure / methods*
  • Drug Administration Schedule
  • Female
  • Humans
  • Infant, Newborn
  • Infant, Premature
  • Intensive Care, Neonatal / methods*
  • Male
  • Oxygen / blood
  • Partial Pressure
  • Pulmonary Surfactants / administration & dosage
  • Regression Analysis
  • Respiratory Distress Syndrome, Newborn / blood
  • Respiratory Distress Syndrome, Newborn / prevention & control*
  • Respiratory Distress Syndrome, Newborn / therapy

Substances

  • Pulmonary Surfactants
  • Oxygen