Minimal ventilation to prevent bronchopulmonary dysplasia in extremely-low-birth-weight infants.
OBJECTIVE
To determine whether minimal ventilation decreases death or bronchopulmonary dysplasia (BPD).


METHODS
Infants with birth weight 501 g to 1000 g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide [PCO(2)] target >52 mm Hg) or routine ventilation (PCO(2) target <48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age.


RESULTS
After enrollment of 220 patients, the trial was halted because of unanticipated nonrespiratory adverse events related to dexamethasone therapy. The relative risk for death or BPD at 36 weeks in the minimal versus routine ventilation groups was 0.93 (95% CI, 0.77-1.12; P =.43). Ventilator support at 36 weeks was 1% in the minimal versus 16% in the routine group (P <.01). Major morbidities and long-term outcome were comparable in both treatment groups.


CONCLUSIONS
With the sample size studied, minimal ventilation did not reduce the incidence of death or BPD. The reduced ventilator support at 36 weeks in the minimal ventilation group warrants further study of this intervention.
Carlo
Waldemar A
WA
University of Alabama at Birmingham, Division of Neonatology, 35233, USA.
Stark
Ann R
AR
Wright
Linda L
LL
Tyson
Jon E
JE
Papile
Lu-Ann
LA
Shankaran
Seetha
S
Donovan
Edward F
EF
Oh
William
W
Bauer
Charles R
CR
Saha
Shampa
S
Poole
W Kenneth
WK
Stoll
Barbara
B
D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D001997:Bronchopulmonary Dysplasia / Q000453:epidemiology / Q000517:prevention & control*; D003131:Combined Modality Therapy; D003907:Dexamethasone / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D008297:Male; D012044:Regression Analysis; D012121:Respiration, Artificial / Q000379:methods*; D014481:United States / Q000453:epidemiology
D000893:Anti-Inflammatory Agents; D003907:Dexamethasone