Neonatal JaundiceNCT03933423
Home Based Phototherapy for Neonatal Jaundice
A study testing Home based phototherapy and referral in people with Neonatal Jaundice, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- Home based phototherapy and referral
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 May 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Pregnant mother with confirmed multiple pregnancy.
- Pregnant mother with medically identified psychological disorder.
- Any known maternal danger sign.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
Mirzapur
Tangail, Dhaka Division
Mahbubur Rahman, MD, MPH, 01712001294, mahbubr@icddrb.org
About this study
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
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.
Read the 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.
- Conditions
- Neonatal Jaundice
- Being tested
- Home based phototherapy and referral
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based phototherapy and referralDevice
Also called Educational session, identifying risk factors and, screening
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Home based phototherapy and referral |
| Control | No intervention | No intervention will be deliver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding rates within 1 hour of age
Mother reported breastfeeding rates within 1 hour of age will be measured following structured survey
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: During 6-8 months of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 May 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Dhaka Shishu Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933423
- Sponsor's protocol ID
- PR-19004
- Status last verified
- Mar 2022
- First submitted
- 23 Apr 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35459113
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03933423
- Acronym / sponsor ID
- PR-19004
- Conditions
- Neonatal Jaundice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Stanford University, Dhaka Shishu Hospital
- Study start
- 1 May 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Device: Home based phototherapy and referralEducational 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. |
| Control | No intervention | –No intervention will be deliver |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Pregnant mother with confirmed multiple pregnancy.
- Pregnant mother with medically identified psychological disorder.
- Any known maternal danger sign.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home based phototherapy and referralAlso: Educational session, identifying risk factors and, screeningCHWs 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 | Device | Intervention |
Primary outcome
Breastfeeding rates within 1 hour of age
Time frame: 6-8 months after the intervention
Mother reported breastfeeding rates within 1 hour of age will be measured following structured survey
Breastfeeding rates upto 3 months of age
Time frame: 6-8 months after the intervention
Mother reported breastfeeding rates after 3 months of age will be measured following structured survey
Number of newborns having at least one postnatal check-up within 48 hours.
Time frame: 6-8 months after the intervention
This measurement will be taken within 2 months of child birth through a structured survey, reported by mother.
Number of newborns screened for neonatal jaundice
Time frame: 6-8 months after the intervention
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.
Number of newborns that received indicated treatment for neonatal jaundice
Time frame: 6-8 months after the intervention
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
Community health workers (CHW's) skill in assessing sick newborns
Time frame: During 6-8 months of the intervention
CHW's skill will be measured through a structured observation following a check list and subjective and objective assessment by registered physician
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 35459113Jahan 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.
- Individual participant dataSharing planned: Undecided
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Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based phototherapy and referral in people with Neonatal Jaundice, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Md Mahbubur Rahman, MBBS (8802-9827001 ext. 4003, mahbubr@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding rates within 1 hour of age (time frame: 6-8 months after the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03933423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.