2.1 Study design and population
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. [23] Around 26% of the mothers delivered via caesarian section. [24] Approximately 62% of the mothers received postnatal care within 2 days of delivery. [24] The nearest hospital for people living in Sakhipur does not have the resources to treat newborns with neonatal hyperbilirubinemia with phototherapy, and newborns are referred to a hospital in the Tangail district 2 hours away for treatment.
2.2 Study Eligibility
All caregivers and families participating in the intervention arm of the study and whose newborns were eligible for home phototherapy treatment participated in the quantitative evaluation.
For the qualitative evaluation, we invited all the households for focus group discussions (FGDs) who were eligible for home phototherapy (n=23). For in-depth interviews, we selected all the mothers (n=3) who either refused or were unable to initiate recommended home phototherapy through purposive sampling and selected eleven mothers whose newborns completed home phototherapy by convenience sampling. All the CHWs (n=10) who delivered the intervention participated in the qualitative evaluation.
2.3 Recruitment and Training of CHWs on home phototherapy
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 field by the study physician over three days in the field and two days in the hospital had the following components. We conducted a pre and post-training assessment to evaluate the CHW’s knowledge acquisition on neonatal jaundice management before and after training.
2.3.1 Assessment of neonatal danger signs and newborn breastfeeding
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 five babies under the supervision of a neonatologist and study physician and received feedback on their performance.
2.3.2 Testing for hyperbilirubinemia
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.
2.3.3 Administration of phototherapy
During the training at Dhaka Children’s Hospital and in the field, 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/cm2/nm. [22] CHWs were trained to complete the following operational and educational checklist with the parents prior to initiating phototherapy. [22] The operational checklist was completed at each followup visit. [22]
A. Operational Checklist
a) Measured temperature between 25-27°C within the bassinet; if the temperature could not be maintained between 25-27°C, an electric heater was provided to maintain the temperature between 25-27°C within the bassinet. If this failed, the infant was referred to the hospital for treatment.
b) Bassinet was covered by a white blanket (Figure 1).
c) Phototherapy device was placed in a safe place on a flat surface.
d) Phototherapy device had a power source and would turn on.
e) Infant was in a bassinet face-up with eye cover and diaper and no other clothes on.
f) Review of parental log on daily number of breastfeedings, urination, and defecation and if the phototherapy unit was turned off overnight from 0000-0600.
[INSERT Figure 1]
B. CHW provided education to mothers and caregivers.
a) CHW explained the need to treat the newborn with phototherapy for neonatal hyperbilirubinemia.
b) Newborns were to be treated for 2 days with phototherapy with two 6-hours breaks at night from midnight to 6 am for approximately 36 hours of phototherapy treatment.
c) Mothers should take newborns out from under the phototherapy lights to breastfeed their newborns every two to three hours for approximately twenty to thirty minutes.
d) CHW would return in four to six hours and then daily until phototherapy treatment and post-treatment monitoring was completed.
e) How the phototherapy device works and how to operate the phototherapy device in the absence of CHWs
- The phototherapy device should be in a safe space on a flat surface.
- How to cover the newborn’s eyes with a mask when the newborn was being treated with phototherapy.
- Infant to be placed in phototherapy bassinet face-up with eye cover and diaper and no other clothes on during treatment.
- Phototherapy unit covered by a white blanket.
- Instruction on how to use a provided a chart to record the daily number of breastfeedings, urination, and defecation and if the phototherapy unit was turned off overnight from 0000-0600.
- How to use diapers during phototherapy, to clean and dry the bassinet if it gets soiled.
- Monitor the newborn for danger signs and contact the designated CHW if any issue arose, if the phototherapy device is turned off for more than 2 hours without resumption of power, and to bring their newborn to the hospital if concerned.
f) Call the CHW if there were issues or questions.
2.4 Prenatal sensitization and education of mothers and family members about home phototherapy
2.4.1 Home-based education of mothers
CHWs conducted home visits to educate mothers and family members on the signs and symptoms of neonatal hyperbilirubinemia and the possible need for treatment with home or hospital-based phototherapy.[22] Each CHW was assigned 26-32 mother-neonate pairs over the implementation period of 4 months. Each mother received at least three sessions starting in their second trimester. They needed to visit 2-3 households per day. During visits, CHWs counselled mothers on pregnancy care, safe delivery, essential newborn care, early initiation of breastfeeding, sensitized the mothers about the signs and symptoms of hyperbilirubinemia, and the importance of testing and treatment to prevent mortality and morbidity. [27] Parents were educated to make a plan for how they would get to the hospital if needed for emergency newborn care and treatment.
2.4.2 Community sensitization on home phototherapy
As the phototherapy device was new to family members, the study team conducted community sensitization meetings for the parents and family members of newborns or infants, community leaders, school teachers, and physicians from government healthcare facilities. Participants were informed of the importance and benefits of phototherapy and were shown the phototherapy device and how it works, the safety of the device and educated on possible adverse effects of home phototherapy.
2.4.3 CHW postnatal evaluation of newborns
CHWs visited home births either within 48 hours of age for home births or the day after discharge from the hospital for newborns born in the hospital by vaginal delivery or by caesarean section. A medical technologist measured the newborn and mother's blood and rhesus type. CHWs measured the newborn weight, evaluated for newborn danger signs, breastfeeding, and maternal danger signs and tested newborns for hyperbilirubinemia with a handheld transcutaneous bilimeter. [22] CHWs were guided by the mHealth algorithm to identify newborns eligible for home phototherapy or if newborns needed to be referred for hospital care.[22] CHWs returned daily for 3 total visits to evaluate for newborn and maternal danger signs, assess breastfeeding, and test for hyperbilirubinemia.
2.5 Eligibility criteria for home phototherapy
The inclusion and exclusion criteria for home phototherapy as described in Foote et al. [22] are as follows-
A. Inclusion criteria of the newborn for home phototherapy are following-
a) Transcutaneous bilirubin (TcB) level above the American Academy of Pediatrics (AAP) phototherapy threshold adjusting for gestational age and presence of rhesus or blood type incompatibility.[28]
Or,
b) TcB rising > 0.2 mg/dL/hour
B. Exclusion criteria of the newborn for home phototherapy are following-
a) Birthweight <2000 grams
b) Gestational age < 35 weeks
c) Newborn danger signs present
d) Maternal danger signs present
e) TcB > 15 mg/dL
Newborns <2000 g, newborns <35 weeks, and newborns with clinical danger signs, or with TcB >15 mg/dL were referred for hospital-level care.
2.6 mHealth decision support for management of hyperbilirubinemia
We developed an mHealth program which guided CHWs to recommend phototherapy at home if there were no newborn danger signs and the TcB level was greater than the AAP phototherapy threshold accounting for gestational age and the presence of blood type or rhesus incompatibility. [22] Phototherapy was also recommended at home if the bilirubin was rising at a rate greater than or equal to 0.2 mg/dL/hour and no danger signs were present.[22] The newborns who met the inclusion criteria were treated for two days with phototherapy with two six-hour breaks at night for approximately 36 hours of phototherapy treatment. Phototherapy treatment was provided by a double surface portable LED phototherapy device (MTTS Firefly phototherapy device), with 12 hours’ battery backup. The irradiance of the device was as follows- top light: irradiance 34.8 µW/cm2/nm, and bottom light: irradiance 50.4 µW/cm2/nm. The phototherapy device had a fixed arm that was 23 inches from the newborn.
2.7 Monitoring of home phototherapy
CHWs visited newborns approximately four to six hours after initiation of phototherapy and then daily for the next two days (four visits in total during phototherapy, and two after completion detailed in Foote et al. [22], to perform a danger sign assessment and breastfeeding assessment, and to see if the phototherapy is ongoing as instructed. Newborns with danger signs were referred for hospital care. For all visits after phototherapy was started, CHWs also completed the operational checklist and a short survey to ensure that the phototherapy device was being used as recommended. CHWs reviewed a parental log to check if the newborns were getting adequate feeding. If CHWs identified issues in the survey or checklist, parents were provided education to address the issues or referred the newborn to the hospital if indicated. CHWs were instructed to contact the study physician if there were any issues with the phototherapy device that CHWs could not resolve or if the family members were refusing recommended treatment. When contacted, the study physician visited the households, assessed the newborn, and referred them to a hospital if there were any danger signs. If there were any issues with the phototherapy device, the physician replaced that device with another device.
2.8 Post-phototherapy monitoring
After home phototherapy was completed, CHWs visited the newborn daily for two days starting the day after phototherapy completion and measured the TcB, and assessed for danger signs. Newborns without danger signs and with a TcB <15 mg/dL for two consecutive days after treatment and a rate of rise of <0.2mg/dL/hour were considered to have been successfully treated for hyperbilirubinemia.[22] If any of the criteria were not met, the newborn was referred to Sakhipur sub-district hospital for further evaluation.[22]
2.9 Assessment of acceptability and operational feasibility of home phototherapy
We conducted quantitative and qualitative assessments to evaluate the acceptability and feasibility of home phototherapy. To assess feasibility, we evaluated whether the implementation of home-phototherapy was conveniently achieved, accounting for facilitation and barriers experienced by CHWs and families. Acceptability was defined as whether the mother and other caregivers (grandparents and fathers) found the home phototherapy likeable and operable.
2.9.1 Quantitative evaluation
A short quantitative survey was conducted by CHWs during each phototherapy visit to assess the acceptability and operational feasibility of home phototherapy for families. Quantitative data were collected using a CommCare-based program. [29] Descriptive analysis was used for the quantitative survey data.
2.9.2 Qualitative evaluation
- In-depth interviews (IDIs) with all study CHWs (n=10) to assess the operational feasibility of home phototherapy led by CHWs.
- IDIs (n=11) with mothers who completed home phototherapy to understand the acceptability and feasibility.
- IDIs (n=3) with mothers who either refused or were unable to initiate recommended home phototherapy to understand reasons for refusal or discontinuation.
- Focus Group Discussions (FGDs) (n=4) with parents and grandparents to assess their perceptions regarding home phototherapy.
2.9.3 Qualitative data collection
A team of researchers with several years of qualitative research experience conducted IDIs and FGDs with mothers and grandparents of enrolled newborns. IDIs and FGDs lasted sixty to ninety minutes and were recorded using digital audio recorders. For each of the FGDs, two to three researchers were engaged; one researcher facilitated the discussion, another acted as co-facilitator and the third researcher took hand-written notes to capture important findings and observations by the researchers. The FGDs were conducted in the backyard of houses and interviews were conducted inside the house to maintain privacy and confidentiality.
2.10 Qualitative data analysis
We analyzed qualitative data using thematic content analysis techniques following an inductive process. Audio recordings were transcribed verbatim into Bengali in the word processor and coded using the qualitative data analysis software Atlas.ti (version 5.2). For coding in Atlas. ti, the research team prepared a set of themes after reading all the transcripts, summaries, and written notes. Four team members coded each transcript based on our primarily generated themes. During the coding process, the team also identified and included new codes. Once all the codes were identified, we sorted and collated coded data extracts into generated themes.
2.11 Ethical approval and consent to participate
This study was conducted under the ethical principles of the Declaration of Helsinki. Written informed consent was obtained from the participants prior to IDIs and FGDs and audio recordings. Participants were offered the opportunity to read the consent form fully and ask and receive answers to any questions before giving their consent. The study protocol was approved by the institutional review boards of icddr,b (IRB/ERC no. PR- 19004) and Stanford University (protocol 52625).