primary outcome:
Prophylactic antibiotics for inhibiting preterm labour with intact membranes
For the infant/childNo differences were shown for perinatal mortality, stillbirth, neonatal or infant death.An increase in CP for the subgroup of children exposed to macrolide (erythromycin) and beta‐lactam antibiotics combined compared with no antibiotics was shown (RR 2.83, 95% CI 1.02 to 7.88), giving the NNTH of 35 (95% CI 333 to 9). Cerebral palsy was not statistically significantly increased for beta‐lactam alone (RR 1.22, 95% CI 0.41 to 3.63), or for macrolide alone (RR 1.42, 95% CI 0.48 to 4.15). The results were not statistically significantly across subgroups (Chi² = 1.41, df = 2 (P = 0.49), I² = 0%), Analysis 2.7.No difference was shown in the measures of functional impairment at seven years of age (test for subgroup differences: Chi² = 0.46, df = 2 (P = 0.80), I² = 0%). A small trend toward an increase in any functional impairment was shown in the subgroups of infants exposed to macrolide and macrolide and beta‐lactam antibiotics (RR 1.13, 95% CI 0.94 to 1.35) Analysis 2.5.For the womanNo data were available for other prespecified primary outcomes for the woman, of serious adverse outcome related to antibiotic treatment (respiratory arrest, cardiac arrest, death) or adverse drug reaction requiring cessation of treatment.For the infant/childThe use of any macrolide (erythromycin and erythromycin and co‐amoxiclav combined) compared with no macrolide antibiotics (co‐amoxiclav or placebo) was associated with an increase in neonatal death (RR 1.52, 95% CI 1.05 to 2.19, NNTH 139, 95% CI 1429 to 61; three trials, 6684 infants) Analysis 3.3.Data from the UK children in the ORACLE II study showed an increase in any functional impairment (RR 1.11, 95% CI 1.01 to 1.20, NNTH 24, 95% CI 263 to 13) Analysis 3.5 at seven years of age (3052 children) and CP (RR 1.90, 95% CI 1.20 to 3.01, NNTH 64, 95% CI 286 to 29; 3173 children) Analysis 3.7. No difference was shown in moderate/severe functional impairment at seven years of age (RR 1.08, 95% CI 0.93, 1.26; 3052 children) Analysis 3.6.No difference was shown in:For the womanNo data were available for other prespecified primary outcomes for the woman, of serious adverse outcome related to antibiotic treatment (respiratory arrest, cardiac arrest, death) or adverse drug reaction requiring cessation of treatment.For the infant/childThe use of any beta‐lactam antibiotics (including beta‐lactam antibiotics alone or in combination with erythromycin) versus no beta‐lactam antibiotics (including erythromycin alone or no antibiotics) was associated with an increase in neonatal death (RR 1.51, 95% CI 1.06 to 2.15, NNTH 143, 95% CI 1250 to 63; seven trials, 7053 infants) Analysis 4.3. Data from UK children in the ORACLE II study showed an increase in CP (RR 1.67, 95% CI 1.06 to 2.61, NNTH 79, 95% CI 909 to 33; one trial, 3173 children) Analysis 4.7.No difference was shown for the following outcomes.For the womanNo data were available for other prespecified primary outcomes for the woman, of serious adverse outcome related to antibiotic treatment (respiratory arrest, cardiac arrest, death) or adverse drug reaction requiring cessation of treatment.