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. 2010 Jan 20;2010(1):CD001079. doi: 10.1002/14651858.CD001079.pub2

Ten Centre 1987.

Methods Randomized 
 Multicenter 
 Blinding of randomization: yes (sealed envelopes) 
 Blinding of intervention: can't tell 
 Complete follow‐up: yes 
 Blinding of outcome measurement: yes 
 Stratification by gestational age (25 to 26 weeks, 27 to 29 weeks)
Long‐term follow‐up: 
 Morley (1990): % survivors followed unclear
Participants Premature infants 
 Inborn 
 Gestational age 25 to 29 weeks 
 Infants randomized: 
 ALEC = 164 
 Saline = 164
Interventions Artificial lung expanding compound (dipalmitdylphosphatidylcholine and phosphatidylglycerol in saline) vs. saline administered in the pharynx if intubated, a second dose was given third and fourth doses were given if intubated at 1 and 24 hours of age
Outcomes PRIMARY OUTCOME: 
 Mortality
SECONDARY OUTCOME: 
 Respiratory Distress Syndrome 
 Complications of prematurity
FOLLOW‐UP: 
 Assessed at 9 and 18 months
Notes Randomized infants: 328 
 Ineligible: 20 
 Total evaluated: 
 ALEC = 159 
 Saline = 149
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Stratification by gestational age (25 to 26 weeks, 27 to 29 weeks)
Allocation concealment? Low risk Blinding of randomization: yes (sealed envelopes)
Blinding? 
 All outcomes Unclear risk Blinding of intervention: can't tell 
 
 Blinding of outcome measurement: yes
Incomplete outcome data addressed? 
 All outcomes Unclear risk Complete follow‐up: yes
Long‐term follow‐up: 
 Morley (1990): % survivors followed unclear
Free of selective reporting? Low risk  
Free of other bias? Low risk