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. 2019 Nov 5;2019(11):CD007647. doi: 10.1002/14651858.CD007647.pub2

Pell 2016.

Methods Cluster‐randomised trial in Kwale County, Kenya
Participants Participants are recruited by CHWs during a home visit during their third trimester
Interventions This trial consists of 4 arms: (1) control, (2) neonatal kit, (3) stimulation, (4) neonatal kit and stimulation
The intervention is delivered by CHWs after consent is received at the routine third trimester visit; appropriate intervention(s) and associated education are delivered
Neonatal kit: consists of a clean birth kit, 4% chlorhexidine solution, sunflower oil emollient, ThermoSpot™, Mylar infant sleeve, and a reusable instant heat pack
Stimulation programme: teaches 3 key messages to enhance caregivers' current practices (e.g. making eye contact and talking to their children, engaging in responsive feeding). These messages are taught at three 15‐minute sessions that take place in participants' homes. They are taught verbally by CHWs, and participants follow the messages via pictorial illustrations of behaviours associated with these messages
Control: the current standard of community‐based prenatal care is delivered by CHWs
Outcomes Primary outcome:
  • Developmental outcomes assessed using PCM‐IT


Secondary outcomes:
  • All‐cause newborn mortality (within first 28 days of life)

  • Incidence of omphalitis, severe infection, identified cases of hypothermia and hyperthermia

  • Number of LBW newborns identified

  • Health facility

  • Knowledge, attitude, practice, and willingness to pay for neonatal kit

Notes Currently, only the protocol is available for this study; therefore no results have been published