Table 3.

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

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)

• The GRADE assessment is based on

1) The volume and consistency of the evidence.

2) The size of summary estimate and

3) The strength of the statistical evidence for an association between the intervention and outcome.

• The quality grade can be interpreted as follows:

High quality— Further research is very unlikely to change our confidence in the estimate of effect

Moderate quality— Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate

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

Very low quality— Any estimate of effect is very uncertain

• This GRADE table is an adaptation form CHERG methods paper[7] and GRADE paper[26]