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Table 3 Summary of findings of trials to assess the effect of application of CHX to newborn’s umbilical cord

From: The effect of umbilical cord cleansing with chlorhexidine on omphalitis and neonatal mortality in community settings in developing countries: a meta-analysis

Quality Assessment Summary of findings
     Generalizability Number of cases Pooled effect
No. of studies Design Limitations Consistency Generalizability to Population of Interest Generalizability to intervention of Interest CHX Control Relative risk (95 % CI)
Sepsis Specific mortality: GRADE quality: Low
1 RCT None Only one trial reported data All the participants were neonates 4.0% chlorhexidine solution. Only RR was reported in the published manuscript. 0.69 (0.40-1.18)
All-Cause neonatal mortality: GRADE quality: Moderate
3 RCT All three included studies are well conducted community randomized trials. Intervention was not masked in two studies. Direction of effect in favor of intervention in all three studies. There was moderate statistical heterogeneity (I2 =50%). All the participants were neonates All the studies used 4.0% chlorhexidine solution. Frequency of application was different in different study groups. 670/29543 655/25072 0.77
(0.63-0.94)
Incidence of omphalitis: Algorithm 1 GRADE quality: Moderate
3 RCT All three included studies are well conducted community randomized trials. Intervention was not masked in two studies. Direction of effect in favor of intervention in all three studies. There was moderate statistical heterogeneity (I2 =34%). All the participants were neonates All the studies used 4.0% chlorhexidine solution. Frequency of application was different in different study groups. Not applicable as data was pooled by generic inverse variance Not applicable as data was pooled by generic inverse variance 0.73
(0.64-00.83)
Incidence of omphalitis: Algorithm 2 GRADE quality: High
3 RCT All three included studies are well conducted community randomized trials. Intervention was not masked in two studies. Direction of effect in favor of intervention in all three studies. No statistical heterogeneity (I2 =0%). All the participants were neonates All the studies used 4.0% chlorhexidine solution. Frequency of application was different in different study groups. Not applicable as data was pooled by generic inverse variance Not applicable as data was pooled by generic inverse variance 0.69
(0.60-0.79)
Incidence of omphalitis: Algorithm 3 GRADE quality: High
3 RCT All three included studies are well conducted community randomized trials. Intervention was not masked in two studies. Direction of effect in favor of intervention in all three studies. Small statistical heterogeneity (I2 =19 %). All the participants were neonates All the studies used 4.0% chlorhexidine solution. Frequency of application was different in different study groups. Not applicable as data was pooled by generic inverse variance Not applicable as data was pooled by generic inverse variance 0.46
(0.32-0.66)
  1. • The GRADE assessment is based on
  2. 1) The volume and consistency of the evidence.
  3. 2) The size of summary estimate and
  4. 3) The strength of the statistical evidence for an association between the intervention and outcome.
  5. • The quality grade can be interpreted as follows:
  6. High quality— Further research is very unlikely to change our confidence in the estimate of effect
  7. Moderate quality— Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
  8. Low quality— Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
  9. Very low quality— Any estimate of effect is very uncertain
  10. • This GRADE table is an adaptation form CHERG methods paper[7] and GRADE paper[26]