Clinical trial NCT03933423: Home Based Phototherapy for Neonatal Jaundice
Official title: Using Community Health Workers and In-home LED Phototherapy to Dramatically Reduce Brain Damage From Neonatal Jaundice in Low to Middle Income Countries: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Jaundice
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Dhaka Shishu Hospital
First posted: 2019-05-01
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of the study is to deliver community health worker based prevention, early screening and management of neonatal Jaundice using battery powered LED phototherapy device at the household level.

Detailed description: Bangladesh like other low and middle-income countries has a high burden of hyperbilirubinemia induced neonatal morbidity and mortality. Approximately 60%-80% of newborns develop neonatal jaundice and 18% of infants are at risk for adverse outcomes from neonatal jaundice. Severe neonatal jaundice can put neonates at risk for long term neuro-developmental impairments and death. Delay in diagnosis and treatment of severe neonatal jaundice can result in brain damage to the newborn that is preventable with timely treatment.

Approximately 14 million infants per year in low to middle-income countries (LMIC) are at risk from neonatal jaundice progressing to extreme hyperbilirubinemia and brain damage. Nearly 80% of the 481,000 cases of extreme hyperbilirubinemia are in LMIC because infants are identified too late or health facility treatment is inaccessible or inadequate.

New, low-cost, easy to use screening and phototherapy treatment technologies enable our proposed redesign of care delivery in LMIC to save infant's brains. The investigators plan to shift care from specialists and hospitals to community health workers (CHW) and homes. Investigators will integrate CHW-led prevention during pregnancy, with timely household screening and treatment. Investigators will reach infants before brain damage occurs and treat infants who would not otherwise be treated.

LMIC including Bangladesh have had difficulty addressing neonatal jaundice because of the expense and logistics of providing timely prevention, screening and treatment to families. This study aim to test 3 hypothesis:

H1: Prenatal modules for pregnant mothers will increase breastfeeding rates at 1 hour of life and at 3 months of age.

H2: CHWs can screen 80% of newborns by 48 hours of age for jaundice and are skilled in identifying sick infants.

H3: CHW-led household screening for neonatal jaundice will increase the rate of indicated treatment for neonatal jaundice compared to current practice.

Investigators will conduct formative research to engage Government and other stakeholders to develop intervention package for prevention and treatment of neonatal jaundice and configuring and adapting LED phototherapy device to use for home treatment. Investigators will then conduct randomized control trial to implement the intervention package in intervention community and will assess the effectiveness of the intervention package. Investigators will compare the rates of indicated treatment for neonatal jaundice in the intervention and treatment arms.

Eligibility criteria: Inclusion Criteria:

* The mothers are at late 2nd or early 3rd trimester of their pregnancy and agreed to enroll as study participants
* They are planning to stay in the study village for the next 12 months (if a mother is planning to give birth at her natal home and then return, she will still not be a candidate for enrollment)

Exclusion Criteria:

* Pregnant mother with confirmed multiple pregnancy.
* Pregnant mother with medically identified psychological disorder.
* Any known maternal danger sign.

Primary outcomes:
measure: Breastfeeding rates within 1 hour of age
timeFrame: 6-8 months after the intervention
measure: Breastfeeding rates upto 3 months of age
timeFrame: 6-8 months after the intervention
measure: Number of newborns having at least one postnatal check-up within 48 hours.
timeFrame: 6-8 months after the intervention
measure: Number of newborns screened for neonatal jaundice
timeFrame: 6-8 months after the intervention
measure: Number of newborns that received indicated treatment for neonatal jaundice
timeFrame: 6-8 months after the intervention
measure: Community health workers (CHW's) skill in assessing sick newborns
timeFrame: During 6-8 months of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Tangail
country: Bangladesh
facility: Mirzapur
state: Dhaka
Study officials:
References:
citation: Jahan F, Foote E, Rahman M, Shoab AK, Parvez SM, Nasim MI, Hasan R, El Arifeen S, Billah SM, Sarker S, Hoque MM, Shahidullah M, Islam MS, Ashrafee S, Darmstadt GL. Evaluation of community health worker's performance at home-based newborn assessment supported by mHealth in rural Bangladesh. BMC Pediatr. 2022 Apr 22;22(1):218. doi: 10.1186/s12887-022-03282-6.