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]

Imdad et al. BMC Public Health 2013 13(Suppl 3):S15   doi:10.1186/1471-2458-13-S3-S15

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