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 |