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

Inositol in preterm infants at risk for or having respiratory distress syndrome

Alexandra Howlett  1 , Arne Ohlsson, Nishad Plakkal
Affiliations

Inositol in preterm infants at risk for or having respiratory distress syndrome

Alexandra Howlett et al. Cochrane Database Syst Rev. .

Abstract

Background: Inositol is an essential nutrient required by human cells in culture for growth and survival. Inositol promotes maturation of several components of surfactant and may play a critical role in fetal and early neonatal life. A drop in inositol levels in infants with respiratory distress syndrome (RDS) can be a sign that their illness will be severe.

Objectives: To assess the effectiveness and safety of supplementary inositol in preterm infants with or without respiratory distress syndrome (RDS) in reducing adverse neonatal outcomes including: death (neonatal and infant deaths), bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC) and sepsis.

Search methods: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 11), MEDLINE via PubMed (1966 to 5 November 2018), Embase (1980 to 5 November 2018), and CINAHL (1982 to 5 November 2018). We searched clinical trial databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials (RCT) and quasi-randomised trials.

Selection criteria: We included all randomised controlled trials of inositol supplementation of preterm infants compared with a control group that received a placebo or no intervention. Outcomes included neonatal death, infant death, bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC) and sepsis.

Data collection and analysis: The three review authors independently abstracted data on neonatal outcomes and resolved any disagreements through discussion and consensus. Outcomes were reported as typical risk ratio (RR), risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB) or number needed to treat for an additional harmful outcome (NNTH). We used the GRADE approach to assess the quality of evidence.

Main results: Six published randomised controlled trials were identified, with a total of 1177 infants. Study quality varied for the comparison 'Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control' and interim analyses had occurred in several trials for the outcomes of interest. In this comparison, neonatal death was found to be significantly reduced (typical RR 0.53, 95% CI 0.31 to 0.91; typical RD -0.09, 95% CI -0.16 to -0.01; NNTB 11, 95% CI 6 to 100; 3 trials, 355 neonates). Infant deaths were not reduced (typical RR 0.89, 95% CI 0.71 to 1.13; typical RD -0.02, 95% CI -0.07 to 0.02; 5 trials, 1115 infants) (low-quality evidence). ROP stage 2 or higher or stage 3 or higher was not significantly reduced (typical RR 0.89, 95% CI 0.75 to 1.06; typical RD -0.04, 95% CI -0.10 to 0.02; 3 trials, 810 infants) (moderate-quality evidence). There were no significant findings for ROP (any stage), NEC (suspected or proven), sepsis, IVH grade greater than II (moderate-quality evidence). For the comparison 'Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at less than 30 weeks' postmenstrual age (PMA) compared to placebo for preterm infants at risk for or having respiratory distress syndrome' the results from two studies of high quality were included (N = 760 neonates). Recruitment to the larger study (N = 638) was terminated because of a higher rate of deaths in the inositol group. We did not downgrade the quality of the study. The meta-analyses of the outcomes of 'Type 1 ROP or death before determination of ROP outcome using the adjudicated ROP outcome', 'Type 1 ROP including adjudicated ROP outcome', 'All-cause mortality (outcome collected through first event: death, hospital discharge, hospital transfer, or 120 days after birth)' and 'Severe IVH (grade 3 or 4)' did not show significant findings (moderate-quality evidence). There were no significant findings for the outcomes 'BPD or death by it prior to 37 weeks' postmenstrual age (outcomes collected through first event: death, hospital discharge, hospital transfer, or 120 days after birth)', 'Late onset sepsis (> 72 hours of age)', and 'Suspected or proven NEC' (high-quality evidence).

Authors' conclusions: Based on the evidence from randomised controlled trials to date, inositol supplementation does not result in important reductions in the rates of infant deaths, ROP stage 3 or higher, type 1 ROP, IVH grades 3 or 4, BPD, NEC, or sepsis. These conclusions are based mainly on two recent randomised controlled trials in neonates less than 30 weeks' postmenstrual age (N = 760), the most vulnerable population. Currently inositol supplementation should not be routinely instituted as part of the nutritional management of preterm infants with or without RDS. It is important that infants who have been enrolled in the trials included in this review are followed to assess any effects of inositol supplementation on long-term outcomes in childhood. We do not recommend any additional trials in neonates.

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Conflict of interest statement

Dr. Alexandra Howlett has no interests to declare.

Dr. Arne Ohlsson has no interests to declare.

Dr. Nishad Plakkal has no interests to declare.

Figures

1
1
Study flow diagram: review update
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Forest plot of comparison: 1 Inositol supplementation (repeat doses in any amount and any duration of treatment) versus control, outcome: 1.5 Retinopathy of prematurity, stage ≥ 3.
5
5
Forest plot of comparison: 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, outcome: 3.4 Type 1 ROP including adjudicated ROP outcome.
6
6
Forest plot of comparison: 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, outcome: 3.14 Late onset sepsis (> 72 hours of age).
1.1
1.1. Analysis
Comparison 1 Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control, Outcome 1 Neonatal death (age < 28 days).
1.2
1.2. Analysis
Comparison 1 Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control, Outcome 2 Infant death (age < one year).
1.3
1.3. Analysis
Comparison 1 Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control, Outcome 3 BPD (supplementary oxygen ar 36 weeks; PMA or death due to BPD)at 36 week's PMA.
1.4
1.4. Analysis
Comparison 1 Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control, Outcome 4 Bronchopulmonary dysplasia (at 28 to 30 days of age).
1.5
1.5. Analysis
Comparison 1 Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control, Outcome 5 Bronchopulmonary dysplasia (at 36 to 38 weeks PMA).
1.6
1.6. Analysis
Comparison 1 Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control, Outcome 6 Retinopathy of prematurity, stage ≥ 3 or ≥ 2.
1.7
1.7. Analysis
Comparison 1 Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control, Outcome 7 Retinopathy of prematurity, any stage.
1.8
1.8. Analysis
Comparison 1 Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control, Outcome 8 Necrotizing enterocolitis (suspected or proven).
1.9
1.9. Analysis
Comparison 1 Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control, Outcome 9 Sepsis (early and/or late onset).
1.10
1.10. Analysis
Comparison 1 Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control, Outcome 10 Intraventricular haemorrhage, grade > 2.
1.11
1.11. Analysis
Comparison 1 Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control, Outcome 11 Intraventricular haemorrhage, all grades.
1.12
1.12. Analysis
Comparison 1 Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control, Outcome 12 Minor neural developmental impairment at one year corrected age.
1.13
1.13. Analysis
Comparison 1 Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control, Outcome 13 Major neural developmental impairment at one year corrected age.
2.1
2.1. Analysis
Comparison 2 Inositol supplementation (single dose of 60 mg/kg or 120 mg/kg) in preterm infants, Outcome 1 Death during hospital stay.
2.2
2.2. Analysis
Comparison 2 Inositol supplementation (single dose of 60 mg/kg or 120 mg/kg) in preterm infants, Outcome 2 Bronchopulmonary dysplasia at 36 weeks PMA.
2.3
2.3. Analysis
Comparison 2 Inositol supplementation (single dose of 60 mg/kg or 120 mg/kg) in preterm infants, Outcome 3 Retinopathy of prematurity (infants who underwent surgery for ROP).
2.4
2.4. Analysis
Comparison 2 Inositol supplementation (single dose of 60 mg/kg or 120 mg/kg) in preterm infants, Outcome 4 Necrotizing enterocolitis (stage 2A or worse).
2.5
2.5. Analysis
Comparison 2 Inositol supplementation (single dose of 60 mg/kg or 120 mg/kg) in preterm infants, Outcome 5 Necrotizing enterocolitis (infants who underwent surgery for NEC).
2.6
2.6. Analysis
Comparison 2 Inositol supplementation (single dose of 60 mg/kg or 120 mg/kg) in preterm infants, Outcome 6 Sepsis (late onset).
2.7
2.7. Analysis
Comparison 2 Inositol supplementation (single dose of 60 mg/kg or 120 mg/kg) in preterm infants, Outcome 7 Intraventricular haemorrhage (grade 3 or 4).
2.8
2.8. Analysis
Comparison 2 Inositol supplementation (single dose of 60 mg/kg or 120 mg/kg) in preterm infants, Outcome 8 Hearing test (failed both ears).
3.1
3.1. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 1 Type 1 ROP or death before determination of ROP outcome using the adjudicated ROP outcome.
3.2
3.2. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 2 Type 1 ROP.
3.3
3.3. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 3 Death before determination of ROP outcome.
3.4
3.4. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 4 Type 1 ROP including adjudicated ROP outcome.
3.5
3.5. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 5 Any ROP.
3.6
3.6. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 6 ROP ≥ 2 ROP.
3.7
3.7. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 7 All cause infant mortality to 55 week's PMA.
3.8
3.8. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 8 All cause mortality (outcome collected through first event: death, hospital discharge, hospital transfer, or 120 days after birth).
3.9
3.9. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 9 BPD (requiring oxygen at 36 week's PMA for oxygen saturation > 90%).
3.10
3.10. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 10 BPD or death by it prior to 37 weeks' PMA (outcomes collected through first event: death, hospital discharge, hospital transfer, or 120 days after birth).
3.11
3.11. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 11 Severe IVH (grade 3 or 4).
3.12
3.12. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 12 Cystic areas in the cerebral parenchyma measured through 28 d.
3.13
3.13. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 13 Early onset sepsis.
3.14
3.14. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 14 Late onset sepsis (> 72 hrs of age).
3.15
3.15. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 15 Suspected or proven NEC.
3.16
3.16. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 16 Surgical NEC.
3.17
3.17. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 17 Spontaneous gastro‐intestinal perforation.
3.18
3.18. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 18 Pulmonary haemorrhage.
3.19
3.19. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 19 PDA.
3.20
3.20. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 20 PDA requiring indomethacin.
3.21
3.21. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 21 PDA requiring surgery.
3.22
3.22. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 22 Seizure treatment for ≥ 2 days.
3.23
3.23. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 23 Negative hearing screening in either ear at discharge.
3.24
3.24. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 24 Respiratory distress syndrome.
3.25
3.25. Analysis
Comparison 3 Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at < 30 weeks' PMA, Outcome 25 Sepsis, necrotizing enterocolitis, pneumonia or other infection as a cause of death.
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Update of

References

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References to other published versions of this review

Howlett 1997
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