Prevention of infection in neonates Neonatal Diseases
Conditions
Interventions
Randomisation is by permuted blocks to guard against bias introduced over time, such as outbreaks of pathogenic bacteria in the hospital.
Maternal:
Chlorhexidine gluconate (CHG) (1% or 2%) or Octenis
Sponsors
St George's, University of London
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Mothers: 1. Presenting in labour with or without rupture of membranes Neonates: 1. Born in Zomba central hospital 2. Postnatal age at randomisation 1000 g
Exclusion criteria
Exclusion criteria: Mothers: 1. Under the age of 18 years (minor in Malawi) 2. Any contra-indication to digital vaginal examination 3. In active labour 4. Poor perineal and vaginal skin condition as judged by a clinician 5. Planned elective caesarean-section delivery 6. Known or suspected allergy to chlorhexidine or octenidine 7. Intrauterine death confirmed or expected before randomsiation 8. Antiseptic application or enrolment in the trial determined inappropriate in the opinion of the enrolling clinician 9. Any recent or planned (within 4 hours) iodine application to the perineum or vagina 10. Unable to obtain consent Neonates: 1. Born by planned elective caesarean section 2. Born to mothers recruited in the trial 3. Poor skin condition (skin score of 2 or more in any of three domains at the time of enrolment) 4. Known congenital or acquired skin disorder or defect at the time of enrolment 5. Antiseptic application or enrolment in the trial determined inappropriate in the opinion of the enrolling clinician 6. Any recent or planned (within 4 hours) iodine application to the body 7. Any planned or previous lumbar puncture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Individual follow up during hospital admission up to discharge in both strata and final follow 28 days after enrolment (by phone if already discharged): Mothers: Vaginal and perineal bacterial load: change in colony-forming units (CFUs) in the vagina (one swab) and perineum (one swab) from randomisation (before antiseptic application) to each timepoint before birth or until 32 h (0, 4, 8, 24, 28, 32 h) of microbiology data collection (efficacy) Neonates: Skin bacterial load: change in colony-forming units (CFUs) in the neck (one swab) and peri-rectal (one swab) from randomisation (before antiseptic application) to each timepoint before discharge or until 72 h [0, 24, 48, 72 h] of microbiology data collection (efficacy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mothers: 1. Tolerability and safety assessed using the modified maternal toxicity score (score and grade) at timepoints before birth or until 32 h (0, 4, 8, 24, 28, 32 h). This score has four domains: one symptom (vaginal/vulval irritation) and three examination signs (redness, skin break down and swelling) 2. Skin bacterial load in neonates exposed to maternal antiseptic, compared to control, measured using colony-forming units (CFUs) in the neck (one swab) and peri-rectal (one swab) at swabs taken once after birth 3. Serious adverse events collected on case report forms at each visit during the inpatient stay, by checking the medical notes and then at the day 28 follow-up visit (over the phone or in person) Neonates: 1. Safety assessed using adapted neonatal skin condition score (absolute score and grade). This score has three domains on examination (dryness, redness, skin breakdown). Measured at 0, 24, 48, 72 h or until discharge, whichever sooner 2. Temperature (change in absolute temperature and grade [hypothermia]). Axillary temperature is measured before and after antiseptic application and once a day in all groups 3. Serious adverse events collected on case report forms at each visit during the inpatient stay, by checking the medical notes and then at the day 28 follow-up visit (over the phone or in person) | — |
Countries
Malawi
Contacts
Public ContactCaroline Albrecht
Outcome results
None listed