Home Based Phototherapy for Neonatal Jaundice

Neonatal Jaundice Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03933423
• Other study ID #: PR-19004
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: Md Mahbubur Rahman, MBBS
• Phone: 8802-9827001
• Email: mahbubr[@]icddrb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Neonatal
• Neonatal Jaundice

Intervention

Device:
• Home based phototherapy and referral
CHWs will visit the household twice in a month and will counsel mother and families on use of preventive care such as routine antenatal check care and newborn care. The investigators will conduct blood grouping and rhesus (Rh) typing. If the mother is Rh negative, investigators will also measure the Rh status of the father prior to delivery to determine the risk of Rh disease in the newborn. The investigators will establish an emergency contact system both in intervention and comparison arm where mothers and family members contact and inform the research team about delivery. The trained phlebotomist will collect cord blood for measuring glucose 6-phosphate dehydrogenase and infant blood type, Rh status, direct antigen testing. The investigators will develop a protocol for treating infants at home based on the ETAT (Emergency Triage Assessment AND Treatment) AAP (American Academy of Paediatrics) guidelines and treat with LED based phototherapy

Locations

Country	Name	City	State
Bangladesh	Mirzapur	Tangail	Dhaka

Sponsors (3)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka Shishu Hospital, Stanford University

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding rates within 1 hour of age	Mother reported breastfeeding rates within 1 hour of age will be measured following structured survey	6-8 months after the intervention
Primary	Breastfeeding rates upto 3 months of age	Mother reported breastfeeding rates after 3 months of age will be measured following structured survey	6-8 months after the intervention
Primary	Number of newborns having at least one postnatal check-up within 48 hours.	This measurement will be taken within 2 months of child birth through a structured survey, reported by mother.	6-8 months after the intervention
Primary	Number of newborns screened for neonatal jaundice	Number of newborns screened for neonatal jaundice either in home or any government or non-government health facilities within 7 days of birth through a structured survey reported by mother.	6-8 months after the intervention
Primary	Number of newborns that received indicated treatment for neonatal jaundice	Number of children receiving indicated treatment for neonatal jaundice either in home or health facilities will be measured by a mother reported structured survey after 2 months of child birth	6-8 months after the intervention
Primary	Community health workers (CHW's) skill in assessing sick newborns	CHW's skill will be measured through a structured observation following a check list and subjective and objective assessment by registered physician	During 6-8 months of the intervention