A single dose of 2G Azithromycin or Placebo will be administered orally to women in labour

Neonatal SEPSIS

Pregnant women attending study health facilities for delivery will be enrolled

The women will be randomized to receive a single dose of Azithromycin or Placebo

Azithromycin

Placebo Oral Tablet

Clinical Research Unit of Nanora

Medical Research Council Unit The Gambia

Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death

Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis and Death: a Phase III Double-blind Randomized Clinical Trial

All deaths excluding Severe Birth Asphyxia (SBA), severe congenital malformation (SCM) and very low birth weight (VLBW)

isolation of a miro-organism that is not a common contaminant from a normally sterile body site (i.e. blood or CSF)

neonate hospitalised within 3 days of life and who in the absence of another recognisable congenital infection had at least one laboratory criteria and either: respiratory distress (one criterion required) or at least two clinical criteria

isolation of a micro-organism that is not a common contaminant from a normally sterile body (i.e. blood or CSF) site if a microorganism has been observed in the gram stain (i.e. CSF)

neonate hospitalised with at least one laboratory criteria and either: respiratory distress (twocriteria required), OR one feature of respiratory distress and one other clinical criterion OR at least two other clinical criteria

Hospitalisation will be defined as admission to an inpatient ward or at least a 12 hour stay. We will exclude from this endpoint all hospitalizations due to injuries

All-cause mortality excluding injuries (only for those included in the anthropometrical sub-study).

through anthropometrical measurements and using WHO child-growth standards to calculate Z-scores for height-for-age (HAZ), weight-for-age (WAZ), weight-for-height (WHZ), head circumference-for-age, and MUAC for age [WHO Anthro version 3.2.2, January 2011]. Children with z-scores <-2SD and <-3SD will be classified as malnourished and severely-malnourished, respectively

this will be defined as admission of the mother for endometritis (defined below) or culture-confirmed infection of sterile site (i.e. blood of CSF; or bacteria detected in the gram stain) or wound infection (see definition below) [23].
Endeometritis: at least two of the following signs of uterine tenderness, fever (>38.0 oC), foul-smelling or purulent lochia, or vaginal discharge diagnosed by clinicians and/or nurses.
Wound infection is defined as perineal wound infection among vaginal parturients or cesarian wound infection among ceasarean section parturients

Hospitalisation will be defined as admission to an inpatient department or a visit to an emergency department that results in at least a 12-hour stay excluding hospitalizations due to injuries

London School of Hygiene and Tropical Medicine

This is a Phase III, double-blind, placebo controlled randomized clinical trial. Women attending the study health facilities in labour will be randomized to receive either a single dose of oral AZI (2g) or placebo (1:1)

The active study drug and placebo will look identical and will not be identifiable. The study drugs will be allocated to the participants according to the randomisation number

pyloric stenosis/febbre

Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death

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