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

Appendix JGRADE tables

These are the complete GRADE tables which accompany the abbreviated versions in the full guideline. These include details of the quality assessment and additional footnoted information which accompanies the main findings. The GRADE findings (evidence profiles) are presented with the same table numbers as the abbreviated tables in the main text of the full guideline to assist cross-referencing. Rows shaded blue in these tables indicate evidence that the GDG viewed as being highly influential in terms of deciding whether to recommend that a particular intervention should or should not be used.

Chapter 4 Information and support

Review question. What information and support should be provided for parents and carers?

No studies were identified for inclusion for this review question.

Chapter 5 Risk factors for infection and clinical indicators of possible infection

Maternal and fetal risk factors

Review question. Which maternal and fetal risk factors for early-onset neonatal infection/sepsis should be used to guide management?

Table J 5.1. Evidence profile for diagnostic test accuracy for predicting early-onset neonatal infection confirmed by a positive blood culture or a positive cerebrospinal fluid culture associated with clinical signs of infection within 72 hours of birth in babies born to women with prelabour rupture of membranes at or after 34 weeks’ gestation (PDF, 77K)

Table J 5.2. Evidence profile for diagnostic test accuracy of individual risk factors, risk scores and composite risk factors for predicting infection confirmed by bacteriological, radiographical or postmortem evidence in the first 10 days of life in babies whose mothers had prolonged rupture of membranes (≥ 24 hours) (PDF, 196K)

Table J 5.3. Evidence profile for performance of healthcare professionals and clinical outcomes before and after introduction of a protocol for evaluating risk of infection immediately after birth in apparently healthy babies born to women with prolonged rupture of membranes (≥ 24 hours) and subsequent clinical management (PDF, 101K)

Table J 5.4. Evidence profile for diagnostic test accuracy of membership of a risk group for predicting morbidity and mortality associated with suspected and presumed infection in singleton babies in the first 5 days of life (PDF, 114K)

Table J 5.5. Evidence profile for diagnostic test accuracy of prolonged preterm prelabour rupture of membranes (> 24 hours) for predicting early-onset neonatal infection (in the first 7 days of life) in extremely premature or low birthweight babies (< 28 weeks’ gestation at birth or birthweight < 1000g) (PDF, 63K)

Table J 5.6. Evidence profile for diagnostic test accuracy of clinical chorioamnionitis, maternal fever or meconium-stained amniotic fluid for predicting early-onset neonatal infection (PDF, 122K)

Table J 5.7. Evidence profile for diagnostic test accuracy of tests based on fetal heart monitoring for predicting early-onset neonatal infection (PDF, 102K)

Table J 5.8. Evidence profile for diagnostic test accuracy of maternal group B streptococcus colonisation for predicting early-onset neonatal infection in the first 7 days of life (PDF, 115K)

Table J 5.9. Evidence profile for diagnostic test accuracy of prematurity and low birthweight for predicting early-onset neonatal infection (PDF, 140K)

Table J 5.10. Evidence profile for diagnostic test accuracy of intrapartum events for predicting early-onset neonatal infection in the first 7 days of life (PDF, 144K)

Table J 5.11. Evidence profile for diagnostic test accuracy of maternal and fetal risk factors for predicting death from early-onset neonatal group B streptococcus infection in babies with positive blood cultures in the first 7 days of life (PDF, 84K)

Chapter 6 Intrapartum antibiotics

Review question. What is the effectiveness of intrapartum antibiotic prophylaxis in the prevention of early-onset neonatal infection (compared to no treatment)?

Women with preterm prelabour rupture of membranes

Table J 6.5. Evidence profile for ampicillin (with or without betamethasone) compared with placebo, betamethasone or no medication in women with preterm prelabour rupture of membranes (PDF, 127K)

Table J 6.6. Evidence profile for benzylpenicillin compared with placebo in women with preterm prelabour rupture of membranes (PDF, 75K)

Table I 6.7. Evidence profile for piperacillin compared with placebo in women with preterm prelabour rupture of membranes (PDF, 79K)

Table J 6.8. Evidence profile for erythromycin compared with placebo in women with preterm prelabour rupture of membranes (PDF, 137K)

Table J 6.9. Evidence profile for amoxicillin plus clavulanic acid compared with placebo in women with preterm prelabour rupture of membranes (PDF, 81K)

Table J 6.10. Evidence profile for ampicillin plus sulbactam compared with ampicillin in women with preterm prelabour rupture of membranes (PDF, 51K)

Table J 6.11. Evidence profile for cephalexin (with or without ritodrine) compared with ritodrine or no medication in women with preterm prelabour rupture of membranes (PDF, 81K)

Table J 6.12. Evidence profile for erythromycin (with or without amoxicillin plus clavulanic acid) compared with placebo (with or without amoxicillin plus clavulanic acid) in women with preterm prelabour rupture of membranes (PDF, 99K)

Table J 6.13. Evidence profile for amoxicillin plus clavulanic acid (with or without erythromycin) compared with placebo (with or without erythromycin) in women with preterm prelabour rupture of membranes (PDF, 99K)

Table J 6.14. Evidence profile for erythromycin and amoxicillin plus clavulanic acid compared with placebo in women with preterm prelabour rupture of membranes (PDF, 97K)

Table J 6.15. Evidence profile for ampicillin and erythromycin followed by amoxicillin and erythromycin compared with placebo in women with preterm prelabour rupture of membranes (PDF, 87K)

Table J 6.16. Evidence profile for ampicillin-sulbactam followed by amoxicillin-clavulanic acid or ampicillin followed by amoxicillin compared with placebo in women with preterm prelabour rupture of membranes (PDF, 65K)

Table J 6.17. Evidence profile for ampicillin, gentamicin and clindamycin followed by amoxicillin plus clavulanic acid compared with placebo in women with preterm prelabour rupture of membranes (PDF, 80K)

Table J 6.18. Evidence profile for 3 days of ampicillin compared with 7 days of ampicillin in women with preterm prelabour rupture of membranes (PDF, 91K)

Table J 6.19. Evidence profile for 3 days of ampicillin-sulbactam compared with 7 days of ampicillin-sulbactam in women with preterm prelabour rupture of membranes (PDF, 55K)

Women with preterm labour

Table J 6.20. Evidence profile for ampicillin-sulbactam followed by amoxicillin-clavulanic acid compared with placebo in women with preterm labour (PDF, 54K)

Table J 6.21. Evidence profile for ampicillin compared with placebo for women with preterm labour (PDF, 94K)

Table J 6.22. Evidence profile for ampicillin-sulbactam and indomethacin compared with placebo in women with preterm labour (PDF, 82K)

Table J 6.23. Evidence profile for co-amoxiclav compared with placebo for women with preterm labour (PDF, 101K)

Table J 6.24. Evidence profile for oral erythromycin compared with placebo for women with preterm labour (PDF, 99K)

Table J 6.25. Evidence profile for erythromycin plus coamoxiclav compared with placebo for women with preterm labour (PDF, 81K)

Table J 6.26. Evidence profile for any co-amoxiclav given with or without erythromycin compared with no co-amoxiclav given (erythromycin only or placebo) for women with preterm labour (PDF, 126K)

Table J 6.27. Evidence profile for any erythromycin given with or without co-amoxiclav compared with no erythromycin (co-amoxiclav only or placebo only) for women with preterm labour (PDF, 106K)

Table J 6.28. Evidence profile for clindamycin compared with placebo for women with preterm labour (PDF, 104K)

Table J 6.29. Evidence profile for erythromycin plus ampicillin compared with placebo for women with preterm labour (PDF, 96K)

Table J 6.30. Evidence profile for ampicillin (followed by pivampicillin) and metronidazole compared with placebo in women with preterm labour (PDF, 48K)

Chapter 7 Routine antibiotics after birth

Review question. In babies with maternal risk factors for early-onset neonatal infection is routine administration of antibiotics to the baby effective in preventing early-onset neonatal infection?

Table J 7.1. Evidence profile for intramuscular benzylpenicillin within 60–90 minutes of birth and then every 12 hours for 3 days versus no early treatment (treatment started 12 hours after birth and then every 12 hours for 3 days) in babies with low birthweight (PDF, 52K)

Table J 7.2. Evidence profile for a single bolus dose versus a 3-day course of intravenous ampicillin plus netilmicin in preterm babies (<32 weeks’ gestation) with risk factors for early-onset neonatal infection (PDF, 64K)

Table J 7.3. Evidence profile for piperacillin (50 mg/kg) plus placebo every 12 hours versus ampicillin (50 mg/kg) plus amikacin (7.5 mg/kg) every 12 hours in babies with risk factors for sepsis (including clinical signs and laboratory abnormalities consistent with sepsis) who were aged less than 7 days (PDF, 84K)

Table J 7.4. Evidence profile for erythromycin eye ointment applied immediately after birth versus 1% silver nitrate eye drops instilled immediately after birth to babies born to women who tested positive to chlamydia (PDF, 69K)

Table J 7.5. Evidence profile for intramuscular benzylpenicillin (50,000 IU) administered to all babies within 1 hour of birth versus no benzylpenicillin prophylaxis (PDF, 110K)

Table J 7.6. Evidence profile for a single intramuscular dose of benzylpenicillin within 1 hour of birth versus topical tetracycline ointment in all babies (PDF, 110K)

Chapter 8 Investigations before starting antibiotics in the baby

Review questions. What investigations of asymptomatic babies after birth are useful in identifying those who should/not be treated for early-onset neonatal infection or determining the treatment strategy?
What investigations should be performed prior to commencing treatment in babies with symptoms and babies with risk factors without symptoms?

Table J 8.1. Evidence profile for diagnostic accuracy of tests based on peripheral white blood cell counts in asymptomatic babies at risk of early-onset neonatal infection (PDF, 349K)

Table J 8.2. Evidence profile for C-reactive protein in babies about to start antibiotic treatment (PDF, 135K)

Table J 8.3. Evidence profile for procalcitonin in babies about to start antibiotic treatment (PDF, 113K)

Table J 8.4. Evidence profile for interleukins in babies about to start antibiotic treatment (PDF, 132K)

Table J 8.5. Evidence profile for diagnostic accuracy of tests based on peripheral white blood cell counts in babies about to start antibiotic treatment (PDF, 175K)

Table J 8.6. Evidence profile for platelet count in babies about to start antibiotic treatment (PDF, 62K)

Table J 8.7. Evidence profile for polymerase chain reaction tests in babies about to start antibiotic treatment (PDF, 93K)

Table J 8.8. Evidence profile for composite measures in babies about to start antibiotic treatment (PDF, 149K)

Table J 8.9. Evidence profile for surface swabs in babies about to start antibiotic treatment (PDF, 61K)

Table J 8.10. Evidence profile for urine latex agglutination test for group B streptococcus antigen in babies about to start antibiotic treatment (PDF, 53K)

Table J 8.11. Evidence profile for urine culture in babies about to start antibiotic treatment (PDF, 62K)

Table J 8.12. Evidence profile for cerebrospinal fluid analysis in babies about to start antibiotic treatment (PDF, 152K)

Chapter 9 Antibiotics for suspected infection

Review question. What is the optimal antibiotic treatment regimen for suspected early-onset neonatal infection?

Table J 9.1. Evidence profile for ampicillin plus gentamicin compared with benzylpenicillin plus gentamicin in babies with suspected early-onset neonatal infectiona (PDF, 169K)

Table J 9.2. Evidence profile for ceftazidime compared with benzylpenicillin plus gentamicin in babies with suspected early-onset neonatal infection (PDF, 72K)

Table J 9.3. Evidence profile for tobramycin compared with gentamicin in babies with suspected early-onset neonatal infection (PDF, 91K)

Table J 9.4. Evidence profile for ticarcillin plus clavulanic acid compared with piperacillin (with or without gentamicin) in babies with suspected early-onset neonatal infection (PDF, 65K)

Table J 9.5. Evidence profile for gentamicin given every 24 hours (4 mg/kg/dose) compared with gentamicin given every 12 hours (2.5 mg/kg/dose) in near-term and term babies (birthweight ≥2500 g) with suspected infection in the first 7 days of life; all babies also received ampicillin (dosage regimen not reported) (PDF, 190K)

Table J 9.6. Evidence profile for gentamicin given every 24 hours (4 mg/kg/dose) compared with gentamicin given every 12 hours (2 mg/kg/dose) in full-term babies with suspected infection in the first 3 days of life; all babies also received ampicillin (200 mg/kg/day) (PDF, 51K)

Table J 9.7. Evidence profile for gentamicin given every 24 hours (5 mg/kg/dose) compared with gentamicin given every 12 hours (2.5 mg/kg/dose) in near-term and term babies (gestational age ≥ 34 weeks, birthweight ≥ 2000 g) with suspected infection in the first 24 hours of life; all babies also received ampicillin (dosage regimen not reported) (PDF, 92K)

Table J 9.8. Evidence profile for gentamicin given every 24 hours (5 mg/kg/dose) compared with gentamicin given every 12 hours (2.5 mg/kg/dose) in babies with suspected early-onset neonatal infection; all babies also received ampicillin (dosage regimen not reported) (PDF, 53K)

Table J 9.9. Evidence profile for gentamicin given every 48 hours (4.5–5 mg/kg/dose) compared with gentamicin given every 24 hours (2.5–3 mg/kg/dose) in very low birthweight babies (600–1500 g) with suspected neonatal infection in the first 7 days of life; all babies also received ampicillin (dosage regimen not reported) (PDF, 160K)

Table J 9.10. Evidence profile for gentamicin given every 48 hours (4.5–5 mg/kg/dose) compared with gentamicin given every 18–24 hours (2.5 mg/kg/dose) in preterm babies (< 34 weeks’ gestation, birthweight 750–2000 g) with suspected neonatal infection in the first 24 hours of life; all babies also received ampicillin (dosage regimen not reported) (PDF, 97K)

Table J 9.11. Evidence profile for a loading dose of gentamicin (4 mg/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) (PDF, 88K)

Table J 9.12. Evidence profile for amikacin given every 24 hours (15 mg/kg/dose) compared with amikacin given every 12 hours (7.5 mg/kg/dose) in near-term and term babies (≥34 weeks’ gestation) with suspected neonatal infection in the first 2 days of life; all babies also received ampicillin every 12 hours (PDF, 101K)

Table J 9.13. Evidence profile for intravenous benzylpenicillin (25,000 IU/kg once every 12 hours compared to 50,000 IU/kg once every 12 hours) in very preterm babies (< 28 weeks’ gestation, birthweight < 1200 g) with suspected infection in the first 3 days of life; all babies also received gentamicin (5 mg/kg every 48 hours) (PDF, 122K)

Table J 9.14. Evidence profile for intravenous benzylpenicillin (50,000 IU/kg) every 12 hours in preterm babies (< 32 weeks’ gestation) with suspected infection in the first 3 days of life; all babies also received tobramycin or cefotaxime (dosage regimens not reported) (PDF, 105K)

Chapter 10 Duration of antibiotic treatment

Review question. What is the optimal duration (or course length) of antibiotics for babies with confirmed early-onset neonatal infection (bacterial cause identified), with presumed symptomatic infection but no bacterial cause identified, with initial clinical suspicion of infection but no ongoing clinical concerns and all investigations normal, and asymptomatic babies receiving prophylactic treatment?

Table J 10.1. Evidence profile for a 4-day course of ampicillin plus gentamicin versus a 7-day course in babies who developed pneumonia within 75 hours of birth and whose respiratory signs resolved within 48 hours of antibiotic treatment; all the babies had received intramuscular benzylpenicillin within 1 hour of birth as part of routine practice to prevent group B streptococcal infection (PDF, 84K)

Table J 10.2. Evidence profile for a 2-day course of antibiotics (probably ampicillin plus gentamicin) versus a 4-day course of the same antibiotics in babies who developed pneumonia within 54 hours of birth and whose respiratory signs resolved within 36 hours of antibiotic treatment; all the babies had received intramuscular benzylpenicillin within 1 hour of birth as part of routine practice to prevent group B streptococcal infection (PDF, 63K)

Table J 10.3. Evidence profile for C-reactive protein in babies receiving antibiotic treatment (PDF, 118K)

Table J 10.4. Evidence profile for C-reactive protein in babies hospitalised within the first 72 hours of life (PDF, 86K)

Table J 10.5. Evidence profile for procalcitonin-guided decision making in relation to duration of empirical treatment with ampicillin plus gentamicin in babies with suspected sepsis in the first 3 days of life versus decision making based on conventional laboratory parameters (immature:total [I:T] neutrophil ratio > 0.2 and C-reactive protein > 5 mg/l) (PDF, 82K)

Chapter 11 Therapeutic drug monitoring for gentamicin

Review question. What is the optimal drug monitoring strategy to achieve effective and safe antibiotic concentrations of gentamicin in the blood in babies with early-onset neonatal infection?

Table J 11.1. Evidence profile for clinical outcomes of therapeutic drug monitoring based on plasma gentamicin concentrations and a two-compartment pharmacokinetic model in critically ill babies with suspected sepsis, proven sepsis or pneumonia who received gentamicin by intravenous infusion (PDF, 115K)

Table J 11.2. Evidence profile for pharmacokinetic outcomes of therapeutic drug monitoring based on plasma gentamicin concentrations and a two-compartment pharmacokinetic model in critically ill babies with suspected sepsis, proven sepsis or pneumonia who received gentamicin by intravenous infusion (PDF, 252K)

Table J 11.3. Evidence profile for therapeutic drug monitoring based on serum gentamicin concentrations and a one-compartment pharmacokinetic model in critically ill babies or babies with suspected sepsis who received gentamicin by intravenous infusion (PDF, 125K)

Table J 11.4. Evidence profile for therapeutic drug monitoring based on serum gentamicin concentrations and a simplified method for individualising dosage regimens (not dependent onindividualised pharmacokinetic modelling) in babies who received gentamicin by intravenous injection in a neonatal intensive care unit (PDF, 132K)

Table J 11.5. Evidence profile for therapeutic drug monitoring based on serum creatinine concentrations in babies who received gentamicin by intravenous infusion in a neonatal intensive care unit (PDF, 163K)

Table J 11.6. Evidence profile for diagnostic test accuracy of serum gentamicin concentrations obtained by convenience sampling as predictors of 24-hour trough concentrations ≤ 1 mg/l in babies with increased risk of sepsis, or suspected or proven sepsisa (PDF, 149K)

Chapter 12 Care setting

Review question. How does the choice of care setting impact on the clinical management of early-onset neonatal infection?

Table J 12.1. Evidence profile for parenteral antibiotic treatment at home after hospital inpatient treatment in babies with suspected or confirmed early-onset neonatal infectiona (PDF, 68K)

Copyright © 2012, National Collaborating Centre for Women’s and Children’s Health.

No part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page.

The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use.

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.

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