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. |
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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. |