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. 2019 Jul 8;2019(7):CD000366. doi: 10.1002/14651858.CD000366.pub4

Hallman 1986.

Methods Randomised, placebo‐controlled, double‐blind trial. Enrolment from 1983 to 1985.
Participants Preterm infants (birth weight < 2000 grams) (mean PMA 29.5, SD 2.0 in the inositol group and 29.5, SD 2.1 in the placebo group) with a diagnosis of RDS, requiring mechanical ventilation.
 N = 74; placebo group = 37, inositol group = 37.
Location: 1 NICU in Helsinki, Finland. Study period: January 1983 to August 1985.
Interventions IV or supplemental inositol (120 to 160 mg/kg/day) or placebo (5% glucose) given daily for 10 days.
Outcomes Neonatal deaths, infant deaths, BPD (supplemental oxygen at 28 days and x‐ray findings compatible with BPD), IVH, ROP (ophthalmological exam at PMA of 9 and 13 months), NEC (clinical findings and abdominal x‐ray showing pneumatosis intestinalis and air in the portal circulation), and sepsis.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided.
Allocation concealment (selection bias) Low risk "Infants were randomly and blindly assigned to be treated with inositol or placebo (glucose) after their parents had consented to their participation". For further details see "Blinding" below.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Each set of solutions, containing either inositol or glucose (5% weight/volume each) had a code number. Only the pharmacist preparing the doses knew the contents of the drug packages.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Of the 83 infants who entered the trial, nine did not fulfil the entrance criteria and were excluded from the final analysis. An explanation was provided for each excluded infant.
Selective reporting (reporting bias) Unclear risk The protocol for the study was not available to us so we cannot judge if there were any deviations between the protocol and the final report.
Other bias High risk The present report represents the third interim analysis and the researchers may have been influenced by the results of the two previous interim analyses. The study was not registered in a trials registry.