Prophylactic nasal continuous positive airways pressure in newborns of 28-31 weeks gestation: multicentre randomised controlled clinical trial
F Sandri, G Ancora, A Lanzoni, P Tagliabue, M Colnaghi, M L Ventura, M Rinaldi, I Mondello, P Gancia, G P Salvioli, M Orzalesi, F Mosca, F Sandri, G Ancora, A Lanzoni, P Tagliabue, M Colnaghi, M L Ventura, M Rinaldi, I Mondello, P Gancia, G P Salvioli, M Orzalesi, F Mosca
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.
Figures
References
- Eur J Pediatr. 2000 Apr;159(4):289-92
- Arch Dis Child Fetal Neonatal Ed. 1999 Sep;81(2):F152-6
- Pediatrics. 2001 Feb;107(2):304-8
- Pediatrics. 2001 Sep;108(3):682-5
- J Radiol Electrol Med Nucl. 1970 May;51(5):259-68
- N Engl J Med. 1971 Jun 17;284(24):1333-40
- Pediatrics. 1973 Jul;52(1):131-4
- Arch Dis Child. 1974 Mar;49(3):228-30
- Early Hum Dev. 1987 Jan;15(1):21-32
- Acta Paediatr Scand. 1990 Jun-Jul;79(6-7):581-6
- Behav Brain Res. 1992 Jul 31;49(1):1-6
- Acta Paediatr. 1993 Nov;82(11):934-8
- Pediatrics. 1994 May;93(5):737-46
- Acta Paediatr. 1994 Feb;83(2):143-9
- N Engl J Med. 1994 Oct 20;331(16):1051-5
- Acta Paediatr. 1995 Jun;84(6):613-6
- Arch Dis Child Fetal Neonatal Ed. 1995 Jul;73(1):F32-6
- JAMA. 1996 Feb 21;275(7):539-44
- Pediatr Pulmonol. 1996 Sep;22(3):188-94
- Eur J Pediatr. 1997 May;156(5):384-8
- Acta Paediatr Suppl. 1997 Apr;419:4-10
- Arch Pediatr Adolesc Med. 1999 Apr;153(4):331-8
- Lakartidningen. 1999 Mar 31;96(13):1571-6
- Arch Dis Child Fetal Neonatal Ed. 2000 Nov;83(3):F182-5
Source: PubMed