Efficacy and tolerance of high-dose inhaled ipratropium bromide vs. terbutaline in intubated premature human neonates.
BACKGROUND
There is insufficient data to reliably assess the benefit of bronchodilators in ventilated premature neonates.


OBJECTIVE
To compare the efficacy/tolerance of inhaled ipratropium bromide (IB) vs. terbutaline (T) and to describe factors associated with their efficacy.


METHODS
A cross-over randomized controlled double-blind trial including intubated neonates with respiratory distress syndrome. Two puffs of IB or T were administered at 0, 20, 40 min. Passive respiratory system resistance (Rrs) and compliance (Crs) were measured at 0, 20, 40, 60 min. A positive response was defined as a >2 individual coefficients of variation decrease in Rrs or increase in Crs.


RESULTS
Twenty-one infants (gestational age (mean +/- SD): 27.3 +/- 1.6 weeks; birth weight: 947 +/- 250 g; postnatal age: 20 +/- 9 days) were included. At 60 min, no treatment effect for Rrs and Crs could be identified (cross-over analysis). Overall data (irrespective of order of administration) showed that after 6 puffs, the decrease in Rrs was greater in the IB vs. T group (-17.0 +/- 22.2% vs. -11.3 +/- 26.7%, respectively (NS)). Thirty-eight percent of infants responded to IB vs. 43% to T. However, in 19% of patients, decreased Crs was observed after 6 puffs of T. No marker of a positive or paradoxical response could be identified. Treatment was well-tolerated.


CONCLUSIONS
High doses of bronchodilators are required in ventilated neonates, but the positive response rate was <50%. Their long-term benefit remains to be proven.
Fayon
Michael
M
Department of Pediatrics and Centre de Recherche (CEDRE), Hôpital Pellegrin-Enfants, CHU de Bordeaux, Bordeaux, France. michael.fayon@chu-bordeaux.fr
Tayara
Nawar
N
Germain
Christine
C
Choukroun
Marie-Luce
ML
De La Roque
Eric Dumas
ED
Chêne
Geneviève
G
Breilh
Dominique
D
Marthan
Roger
R
Demarquez
Jean-Louis
JL
D000280:Administration, Inhalation; D000403:Airway Resistance / Q000187:drug effects / Q000502:physiology; D001724:Birth Weight; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D009241:Ipratropium / Q000627:therapeutic use*; D008170:Lung Compliance / Q000187:drug effects / Q000502:physiology; D008297:Male; D012121:Respiration, Artificial; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy* / Q000503:physiopathology; D013726:Terbutaline / Q000627:therapeutic use; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D009241:Ipratropium; D013726:Terbutaline