Prophylactic nasal continuous positive airways pressure in newborns of 28–31 weeks gestation: multicentre randomised controlled clinical trial
- F Sandri1,
- G Ancora1,
- A Lanzoni1,
- P Tagliabue2,
- M Colnaghi3,
- M L Ventura2,
- M Rinaldi4,
- I Mondello5,
- P Gancia6,
- G P Salvioli1,
- M Orzalesi7,
- F Mosca3,
- on behalf of the Pneumology Study Group of the Italian Society of Neonatology
- 1Institute of Neonatology, University of Bologna, Bologna, Italy
- 2Division of Neonatology, San Gerardo Hospital, Monza, Italy
- 3Department of Neonatology, Clinica Mangiagalli, ICP, Milano, Italy
- 4Division of Neonatology, Ospedali Riuniti, Foggia, Italy
- 5Division of Neonatology, Bianchi Melacrino Morelli Hospital, Reggio Calabria, Italy
- 6Division of Neonatology, Policlinico S Matteo, Pavia, Italy
- 7Department of Medical and Surgical Neonatology, Bambino Gesù Children’s Hospital, Rome, Italy
- Correspondence to:
Istituto di Neonatologia, Via Massarenti, 11 40138 Bologna, Italy;
- Accepted 1 February 2004
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
- respiratory distress syndrome
- preterm newborn