Table 9.11Evidence profile for a loading dose of gentamicin (4mg/kg) compared with a standard initial dose of gentamicin (2.5 mg/kg) in babies with suspected neonatal infection in the first 12 hours of life; all babies received maintenance doses of 2.5 mg/kg/dose every 12, 18 or 24 hours depending on gestational age and birthweight; all babies also received ampicillin (200–400 mg/kg/day)

Number of studiesNumber of babiesEffectQuality
Gentamicin loading dose (4 mg/kg)Gentamicin standard initial dose (2.5 mg/kg)Relative (95% confidence interval)Absolute (95% confidence interval)
Clinical effectiveness
Mortality
1
(Isemann 1996)
1/18
(6%)
0/16
(0%)
RR 2.68 (0.12 to 61.58)*NCLow
Hearing impairment (assessed by the brainstem-evoked auditory response test)
1
(Isemann 1996)
3/12
(25%)
2/10
(20%)
RR 1.25 (0.26 to 6.07)*50 more per 1000
(148 fewer to 1000 more)*
Low
Kidney impairment (assessed by decrease in urine output and increase in serum creatinine)
1
(Isemann 1996)
1/18
(6%)
0/16
(0%)
RR 2.68 (0.12 to 61.58)*NCLow
Pharmacokinetics
Peak concentrations (> 5 microgram/ml) after the first dose
1
(Isemann 1996)
17/18
(94%)
1/16
(6%)
RR 15.11 (2.26 to 101.14)*882 more per 1000
(79 more to 1000 more)*
Low
Peak concentrations > 10 microgram/ml after the first dose
1
(Isemann 1996)
0/18
(0%)
0/16
(0%)
NCNCLow
Trough concentrations > 2 microgram/ml before the second dose (which was administered 12, 18 or 24 hours after the first dose, depending on gestational age and birthweight)
1
(Isemann 1996)
10/18
(56%)
0/16
(0%)
RR 18.79 (1.19 to 297.03)*NCLow

NC not calculable, RR relative risk

*

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

See the complete GRADE Table J 9.11

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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