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Home Based Phototherapy for Neonatal Jaundice

NCT03933423 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2022-03-31

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Stanford University

    collaborator OTHER

  • Dhaka Shishu Hospital

    collaborator OTHER

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Bangladesh

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03933423 on ClinicalTrials.gov