Community health worker-led household screening and management of neonatal hyperbilirubinemia in rural Bangladesh: a cluster randomized control trial protocol

Abstract

Background: Extreme hyperbilirubinemia leading to neurologic disability and death is disproportionately high in low to middle income countries (LMIC) such as Bangladesh, and is largely preventable through timely treatment. Of the estimated 50% of newborns born in LMICs born at home, few receive screening or treatment for hyperbilirubinemia, leading to 6 million newborns per year who need phototherapy treatment for hyperbilirubinemia but are untreated. Household screening and treatment for neonatal hyperbilirubinemia with phototherapy administered by a trained community health worker (CHW) may increase indicated treatment for neonatal hyperbilirubinemia in comparison to the existing care system in Bangladesh. Methods: 530 Bangladeshi women in their 2nd or 3rd trimester of pregnancy from the rural community of Sakhipur, Bangladesh will be recruited for a cluster randomized trial and randomized to the intervention arm — home screening and treatment for neonatal hyperbilirubinemia — or the comparison arm to receive usual care. In the intervention arm, CHWs will provide mothers with two prenatal visits, visit newborns by 2 days of age and then daily for 3 days to measure transcutaneous bilirubin (TcB) and monitor clinical danger signs. Newborns without danger signs but with a TcB above the treatment threshold <15 mg/dL will be treated with light-emitting diode (LED) phototherapy at home. Newborns with danger signs or TcB >15 mg/dL will be referred to a hospital for treatment. Treatment rates for neonatal hyperbilirubinemia in each arm will be compared. Conclusion: This study will evaluate the effectiveness of CHW-led home phototherapy to increase neonatal hyperbilirubinemia treatment rates in rural Bangladesh. LMICs are expanding access to postnatal care by using CHWs, and our work will give CHWs a curative treatment option for neonatal hyperbilirubinemia. Similar projects in other LMICs can be pursued to dramatically extend healthcare access to vulnerable newborns with hyperbilirubinemia.

Acceptability and operational feasibility of community health worker-led home phototherapy treatment for neonatal hyperbilirubinemia in rural Bangladesh

“…As part of a cluster randomized controlled trial (NCT03933423) among pregnant women 18 years of age or older in their second or third trimester of pregnancy and the newborns born to enrolled mothers, we conducted this mixed-method investigation from November 2019 to May 2020 and January 2021 to May 2021 to evaluate the operational feasibility and acceptability of CHW-led home phototherapy. [22] This study was conducted in the Sakhipur sub-district of Tangail district, a rural hard-to-reach area with ~300,000 population located 80 kilometers from the capital Dhaka. Around 98% of the pregnant women in the study area have had at least one antenatal care (ANC) visit and around 50% of the pregnant women delivered at home.…”

“…The selection and training of CHWs have been described in detail in the protocol paper of the main trial. [22] We conducted both theoretical and hands-on training for CHWs for neonatal hyperbilirubinemia management and operation of the phototherapy device. The training of CHWs occurred at Dhaka Children's Hospital by neonatologists and in the eld by the study physician over three days in the eld and two days in the hospital had the following components.…”

“…The hands-on training to assess newborns and mothers for danger signs and breastfeeding assessment included maintaining hand hygiene before examining the newborn, and examination of the newborn for ten danger signs adopted from the 2009 National Newborn Health Strategy [25] which has been detailed in the CHW assessment validation paper and study protocol. [22,26] CHWs examined ve babies under the supervision of a neonatologist and study physician and received feedback on their performance.…”

“…CHWs were trained to test newborns for hyperbilirubinemia with a transcutaneous bilimeter, and to determine when a newborn is eligible for home phototherapy based on the birth weight, gestational age, presence of danger signs, and bilirubin level with the aid of an mHealth algorithm, which has been elaborated in Foote et al [22] Adequacy of performance of TcB measurement was assessed in the hospital.…”

“…During the training at Dhaka Children's Hospital and in the eld, CHWs were taught how to operate the phototherapy device, to educate parents on how the newborn should be treated with phototherapy in their absence, and to call the study physician if they needed additional help. [22] CHWs were trained to check the irradiance of the phototherapy device before each use in the home using the manufacturer recommended irradiance meter (Lightmeter V7.0) to ensure that the irradiance is at least 50 µW/cm 2 /nm. [22] CHWs were trained to complete the following operational and educational checklist with the parents prior to initiating phototherapy.…”