Home Based Phototherapy for Neonatal Jaundice

NCT03933423 | Unknown DMC

• 1 other identifier: PR-19004
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Jaundice

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Educational session of pregnant mothers, blood grouping of parents and identifying risk factors for developing jaundice, screening newborns for neonatal jaundice, glucose 6-phosphate dehydrogenase deficiency and illness, Home based phototherapy and referral.

Device: Home based phototherapy and referral

Control

NO INTERVENTION

No intervention will be deliver

Interventions

Home based phototherapy and referral DEVICE

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

Also known as: Educational session, identifying risk factors and, screening

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant mothers above 18 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Stanford University: collaborator
• Dhaka Shishu Hospital: collaborator

Study Sites (1)

Mirzapur

Tāngāil, Dhaka Division, Bangladesh

RECRUITING

Related Publications (1)

• 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.

  PMID: 35459113 DERIVED

MeSH Terms

Conditions

Jaundice, Neonatal

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Central Study Contacts

Md Mahbubur Rahman, MBBS

CONTACT

8802-9827001; mahbubr@icddrb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 1, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

BA (1)