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


METHODS
Multicentre randomised controlled clinical trial.


METHODS
Seventeen Italian neonatal intensive care units.


METHODS
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.


METHODS
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.


METHODS
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.
Instituto di Neonatologia, Via Massarenti, 11 40138 Bologna, Italy. sandri@med.unibo.it
F
F
Sandri
G
G
Ancora
A
A
Lanzoni
P
P
Tagliabue
M
M
Colnaghi
M L
ML
Ventura
M
M
Rinaldi
I
I
Mondello
P
P
Gancia
G P
GP
Salvioli
M
M
Orzalesi
F
F
Mosca
D045422:Continuous Positive Airway Pressure / Q000009:adverse effects / Q000379:methods*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D015931:Intensive Care, Neonatal / Q000379:methods*; D008297:Male; D010100:Oxygen / Q000097:blood; D010313:Partial Pressure; D011663:Pulmonary Surfactants / Q000008:administration & dosage; D012044:Regression Analysis; D012127:Respiratory Distress Syndrome, Newborn / Q000097:blood / Q000517:prevention & control* / Q000628:therapy
D011663:Pulmonary Surfactants; D010100:Oxygen