Table 9.1Evidence profile for ampicillin plus gentamicin compared with benzylpenicillin plus gentamicin in babies with suspected early-onset neonatal infectiona

Number of studiesNumber of babiesEffectQuality
Ampicillin plus gentamicinBenzylpenicillin plus gentamicinRelative (95% confidence interval)Absolute (95% confidence interval)
Treatment failure (need for change of antibiotics or death within 7 days)
1
(Metsvaht 2010)
20/142
(14.1%)
20/141
(14.2%)
RR 0.99
(0.56 to 1.76)*
1 more per 1000
(62 fewer to 108 more)*
Low
Mortality
7-day mortality
1
(Metsvaht 2010)
11/142
(7.7%)
14/141
(9.9%)
RR 0.78
(0.37 to 1.66)*
22 fewer per 1000
(63 fewer to 66 more)*
Low
Mortality in the neonatal intensive care unit
1
(Metsvaht 2010)
13/142
(9.2%)
23/141
(16.3%)
RR 0.56
(0.30 to 1.06)*
72 fewer per 1000
(114 fewer to 10 more)*
Low
Mortality in the neonatal intensive care unit in babies < 26 weeks’ gestationb
1
(Metsvaht 2010)
6/24
(25.0%)
13/21
(61.9%)
RR 0.40
(0.19 to 0.87)*
371 fewer per 1000
(80 fewer to 501 fewer)*
Low
Colonisation with ampicillin-resistant Gram-negative bacteria
1
(Metsvaht 2010)
44/142
(30.9%)
44/141
(31.2%)
RR 0.99
(0.70 to 1.40)*
3 fewer per 1000
(94 fewer to 125 more)*
Low
Colonisation with Staphylococcus haemolyticusc
Number of babies colonised
1 (Parm 2010)NR/139NR/137NCMore in the ampicillin group
P = 0.039
Low
Mean colonisation duration (days colonised per 100 intensive care unit days)d
1 (Parm 2010)NRNRNCLonger in the ampicillin group
P = 0.001
Low
Colonisation with Klebsiella pneumoniaec
Number of babies colonised
1 (Parm 2010)NR/139NR/137NCMore in the ampicillin group
P = 0.107
Low
Mean colonisation duration (days colonised per 100 intensive care unit days)d
1 (Parm 2010)NRNRNCLonger in the ampicillin group
P = 0.012
Low
Colonisation with Staphylococcus hominisc
Number of babies colonised
1 (Parm 2010)NR/139NR/137NCMore in the ampicillin group
P = 0.003
Low
Mean colonisation duration (days colonised per 100 intensive care unit days)d
1 (Parm 2010)NRNRNCLonger in the ampicillin group
P = 0.001
Low
Colonisation with Enterococcus speciesc
Number of babies colonised
1 (Parm 2010)NR/139NR/137NCFewer in the ampicillin group
P < 0.001
Low
Mean colonisation duration (days colonised per 100 intensive care unit days)d
1 (Parm 2010)NRNRNCShorter in the ampicillin group
P = 0.001
Low
Colonisation with Staphylococcus aureus c
Number of babies colonised
1 (Parm 2010)NR/139NR/137NCFewer in the ampicillin group
P = 0.006
Low
Mean colonisation duration (days colonised per 100 intensive care unit days)d
1 (Parm 2010)NRNRNCShorter in the ampicillin group
P = 0.052
Low
Colonisation with ampicillin-resistant Acinetobacter speciesc
Number of babies colonised
1 (Parm 2010)NR/139NR/137NCFewer in the ampicillin group
P = 0.996
Low
Mean colonisation duration (days colonised per 100 intensive care unit days)d
1 (Parm 2010)NRNRNCShorter in the ampicillin group
P = 0.001
Low
Number of babies colonised with Acinetobacter speciesc
1 (Parm 2010)NR/139NR/137NCFewer in the ampicillin group
P = 0.224
Low
Number of babies colonised with Enterobacter cloacaec
1 (Parm 2010)NR/139NR/137NCFewer in the ampicillin group
P = 0.142
Low

NC not calculable, NR not reported, P probability, RR relative risk

*

Calculated by the NCC-WCH technical team from data reported in the article

a

Early-onset infection defined as infection in the first 72 hours of life

b

Mortality in other groups classified by gestational age (< 28 weeks and > 36 weeks) not reported; possibility of selective reporting of statistically significant results

c

Results of multivariate mixed effect model analysis

d

Monitoring for colonisation was conducted via rectal swabs on admission to the intensive care unit and twice a week thereafter until discharge from the unit or day 60 if this occurred earlier; colonisation duration represents the ratio of colonising days to 100 intensive care unit days counted from the first to last positive culture with 2 days added to compensate for the sampling interval of 3–4 days

See the complete GRADE Table J 9.1

From: 9, Antibiotics for suspected infection

Cover of Antibiotics for Early-Onset Neonatal Infection
Antibiotics for Early-Onset Neonatal Infection: Antibiotics for the Prevention and Treatment of Early-Onset Neonatal Infection.
NICE Clinical Guidelines, No. 149.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2012 Aug.
Copyright © 2012, National Collaborating Centre for Women’s and Children’s Health.

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