Early Childhood DevelopmentRINEWNCT04111016
Feasibility of Implementing RINEW Through the Government System
An observational study of Early Childhood Development, run by Stanford University at 1 site in Bangladesh.
Trial summary
The goal of this study is to assess the feasibility of implementing a group-based integrated early child development intervention through the government health system in one sub-district of Bangladesh, and to assess the resulting uptake of the intervention in the target population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Childhood Development
- What is being tested?
- Integrated child stimulation, nutrition, lead, arsenic, WASH intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,823 participants
- Where
- 1 siteBangladesh
- Study dates
- 6 Apr 2019to 16 Sep 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chatmohar sub-district of Pabna has been selected to implement the integrated intervention through the government system. All Chatmahor residents with children <2 or families of pregnant women are eligible to participate (attend health facilities offering the intervention) The selection of Chatmohar was based on meeting the following criteria: i. Communication status from Dhaka: should have a good by road communication (Bus/train) ii. Presence of a local champion in the government health system: UH\&FPO should be known and enthusiastic to implement an integrated intervention in the sub-district iii. Low percentage of vacant posts for government frontline health workers: <25% vacant posts iv. Most of the community clinic should be active v. Receptive and less conservative community vi. Community that is exposed to arsenic and lead contamination
Who may be able to join
- 1) Government health workers who are participating in the facilitation or supervision of RINEW sessions
- Inclusion criteria for qualitative interviews with intervention attendees 1) Mothers or primary caregivers eligible for the intervention sessions
- Exclusion criteria for qualitative interviews with intervention attendees
- 1) Child, mother, or primary caregiver with impaired cognitive development, or hearing, vision, speech impaired child or mother
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka
About this study
Official title: Exploring the Feasibility of Implementing an Integrated Nutrition, Early Childhood Development and WASH (RINEW) Intervention Through the Government Health System: A Pilot Study
The goal of this study is to assess the feasibility of implementing a group-based integrated early child development intervention through the government health system in one sub-district of Bangladesh, and to assess the resulting uptake of the intervention in the target population.
Read the detailed description
The RINEW intervention is a group-based integrated nutrition, responsive stimulation, and WASH intervention with a goal to improve child development outcomes. The intervention is delivered in group sessions to pregnant women and mothers or primary caregivers of children under 24 months of age. The RINEW intervention was tested in a pilot cluster-randomized control study in Bangladesh, where the investigators found the intervention group had better self-reported knowledge and behavior related to early child development. The investigators aim to implement this intervention through the government health system in one sub-district of Bangladesh, and assess the feasibility of delivering the intervention in this way, as well as the uptake of the intervention in the target population. The facilitators will be trained by the study team, and the intervention will be implemented in community-level health centers, facilitated by government health workers.
The specific objectives of this work are to:
- Assess the feasibility (i.e. satisfaction of providers, perceived appropriateness of content and practicability of session delivery, population demand for sessions, quality and frequency of implementation, and preparedness of health system) of implementing the RINEW intervention through the government health system
- Identify barriers, facilitators/opportunities, and pathway for scale up of the RINEW intervention through government health system
- Assess the coverage of the intervention in the target population
- Assess the uptake of recommended behaviors in the target population
To reach these objectives the investigators will
- Train government health workers to deliver the intervention at government health facilities
- Conduct a clinic-based process evaluation using both quantitative and qualitative methods at multiple time points during the 12-months intervention
- Conduct population-based quantitative baseline and endline assessments to assess intervention coverage and uptake
- Conditions
- Early Childhood Development
- Being tested
- Integrated child stimulation, nutrition, lead, arsenic, WASH intervention
- Keywords
- Early childhood development, Responsive parenting, Nutrition, WASH, Stimulation, Parenting, Integrated Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated child stimulation, nutrition, lead, arsenic, WASH interventionBehavioural
The content of the intervention curriculum was developed considering the needs of the specific ages of the children attending the group, as well as the feasibility of delivering the package in the community. The pregnancy module encompasses information on significance of prenatal care for child development, physiological symptoms and solutions, maternal diet, education on kangaroo mother care (KMC), breast feeding, thinking healthy, hygiene, and lead and arsenic prevention. The curriculum for lactating mothers focuses on specialized messages for 4 age groups of children: 0-5 months, 6-11 months, 12-18 months and 19-24 months. The overall package includes information regarding WASH, psychosocial stimulation, nutrition, maternal mental health, lead and arsenic. As research evidence showed that psychosocial stimulation provided for 10 or 12 months can significantly improve child development, the psychosocial stimulation component is included in every fortnightly session.
| Study group | Role | What they receive |
|---|---|---|
| Participants able to access the intervention | These group sessions will be delivered by government health workers, and include behavioral recommendations about responsive stimulation, nutrition, water, sanitation and hygiene, lead poisoning prevention, and maternal mental health. Pregnancy groups and caregiver-child groups will be held separately, and mothers and caregivers who attend sessions will receive simple toys and books to use during some of the intervention sessions, which they will be permitted to take home with them. In addition, mothers and caregivers who attend intervention sessions will receive 30 sachets containing 1 gm multiple micronutrient powder (MNP) per month. Beginning as soon as pregnancy is confirmed, health workers will facilitate pregnant women in receiving the Iron and Folic acid supplements already provided by the Government of Bangladesh and will continue the supplementation up to three months post-partum period. Receives: Behavioral: Integrated child stimulation, nutrition, lead, arsenic, WASH intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in session quality
Semi-structured checklist for one pregnancy session and one mother-baby session in each health facility per assessment time period.
Measured: 2nd, 6th and 12th month of the intervention; ~60 min per assessment
Change in proportion of planned session conducted
This data will be reported by the intervention facilitators and collected by the intervention supervisors on a monthly basis.
Measured: Every 2 weeks through study completion; ~10 min
Change in number and proportion of eligible pregnant women and mother attendees at each session
The attendance numbers will be collected at each pregnancy and mother-baby session, and reported to the study team on a monthly basis.
Measured: Monthly through study completion; ~15 min/assessment
Change in satisfaction of trained health workers with training and intervention implementation: Semi-structured individual interviews and focus group discussions
Semi-structured individual interviews and focus group discussions with intervention implementors and their supervisors.
Measured: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
Change in determinants of session quality
Semi-structure individual interviews and focus group discussions with a purposive sample of intervention implementors, their supervisors, and intervention attendees
Measured: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
Change in determinants of session attendance
Semi-structure individual interviews and focus group discussions with a purposive sample of intervention implementors, their supervisors, and intervention attendees
Measured: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
Secondary outcomes (9)
Change in individual-level attendance records and self-reports
Attendance to group sessions over the intervention period will be recorded on participant-held attendance records. At the end line assessment participants will also be asked to show their intervention cards and report the number of sessions they have attended over the previous 12 months.
Measured: Monthly through study completion; ~3 min/assessment
Change in caregiver early child development knowledge and practices
A modified version of the Family Care Indicators (FCI), including self-reported behaviors and knowledge and observations during the interview, will be used to measure childhood development knowledge and practices. The FCI has the following sub-scales: 1) household books (number); 2) magazines or newspapers in the household (number), 3) sources of play materials (number of 3 possible categories), 4) varieties of play materials (number of 7 possible categories), 5) play activities (number of 6 possible categories). The scores from each sub-scale are summed to calculate the total score. For all sub-scales and the total score, higher scores are associated with a better child care. Investigators will also assess 11 additional observational items including observations of the home environment, and parental responsiveness and acceptance during the interview. Positive responses are summed to create an observation score.
Measured: Baseline and 12 months after intervention; ~15 min/assessment
Change in child dietary diversity, child minimum meal frequency and minimum acceptable diet.
Child dietary diversity will be calculated based on the number of 7 different food groups consumed by the child yesterday. This will be determined based on a maternal-reported 24 hour recall of all foods consumed by the mother and the child. Minimum acceptable diet is determined by the child's dietary diversity and meal frequency.
Measured: Baseline and 12 months after intervention; ~15 min/assessment
Change in maternal dietary diversity
Maternal dietary diversity indicated by the number of 10 different food groups consumed by the mother yesterday. This will be determined based on a maternal-reported 24 hour recall of all foods consumed by the mother and the child.
Measured: Baseline and 12 months after intervention; ~5 min/assessment
Change in maternal depressive symptoms
Caregiver mental health will be measured using the Center for Epidemiologic Studies Depression scale (CESD), which includes 20 questions about symptoms experienced in the previous week. Number of days experiencing each symptom in the last week is converted into a score: 0= 0 or less than 1 day; 1= 1-2 days; 2= 3-4 days, 3=5-7 days, and the total score is a sum of negative symptoms experienced (positive items are reverse scored). The score ranges from 0-60, with higher scores indicating more depressive symptoms experienced.
Measured: Baseline and 12 months after intervention; ~5 min/assessment
Change in maternal knowledge regarding lead, nutrition, WASH, and arsenic
This will be assessed with self-report questions about knowledge about lead exposure and prevention, nutrition, WASH, and arsenic exposure.
Measured: Baseline and 12 months after intervention; ~5 min/assessment
Change in self-reported behaviour regarding prevention of lead contamination, disposal of human and chicken feces, water and food storage
This will be assessed with self-reported questions about behaviours regarding prevention of lead contamination, disposal of human and chicken feces, water and food storage.
Measured: Baseline and 12 months after intervention; ~5 min/assessment
Change in availability and accessibility of safe water storage containers, hygienic toilet, handwashing station, child potty (for >6 months to 2 year old children), and covers for cooked food.
This will be measured with self-reported behaviors, as well as observations of water storage facilities, latrine quality, handwashing station and child potty.
Measured: Baseline and 12 months after intervention; ~5 min/assessment
Change in responsive feeding and interactions during mealtime
This will be assessed with self-reported interactions mother/caregiver follow during feeding (complementary foods) to their 6-24 months old children
Measured: Baseline and 12 months after intervention; ~5 min/assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start6 Apr 2019
- Primary completion16 Sep 2020
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early Childhood DevelopmentStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,823 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, University of California, Berkeley, Johns Hopkins University, BRAC University
- Responsible party
- Principal investigator, Stephen P Luby, Stanford University
- Investigators
- Stephen P Luby, Dr., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111016
- Sponsor's protocol ID
- 50733
- Acronym
- RINEW
- Status last verified
- May 2022
- First submitted
- 30 May 2019
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sultana J, Pitchik HO, Shoab AK, Huda TMN, Hasan R, Akter F, Jahir T, Khobair Hossain M, Das JB, Amin MR, Yeasmin F, Khan R, Forsyth JE, Kwong LH, Rashid J, Ashrafee S, Rahman M, Mridha MK, Tofail F, Winch PJ, Luby SP, Fernald LCH. Evaluation of a multicomponent child development intervention delivered through the government health system: a feasibility study. BMJ Glob Health. 2025 Jul 20;10(7):e018736. doi: 10.1136/bmjgh-2024-018736.
PubMed 40685160Winters S, Pitchik HO, Akter F, Yeasmin F, Jahir T, Huda TMN, Rahman M, Winch PJ, Luby SP, Fernald LCH. How does women's empowerment relate to antenatal care attendance? A cross-sectional analysis among rural women in Bangladesh. BMC Pregnancy Childbirth. 2023 Jun 13;23(1):436. doi: 10.1186/s12884-023-05737-9.
PubMed 37312017
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility of Implementing an Integrated Nutrition, Early Childhood Development and WASH (RINEW) Intervention Through the Government Health System: A Pilot Study
- ClinicalTrials.gov ID
- NCT04111016
- Acronym / sponsor ID
- RINEW / 50733
- Conditions
- Early Childhood Development
- Keywords
- Early childhood development, Responsive parenting, Nutrition, WASH, Stimulation, Parenting, Integrated Interventions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,823 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, University of California, Berkeley, Johns Hopkins University, BRAC University
- Study start
- 6 Apr 2019 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 1 Oct 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 goal of this study is to assess the feasibility of implementing a group-based integrated early child development intervention through the government health system in one sub-district of Bangladesh, and to assess the resulting uptake of the intervention in the target population.
Detailed description
The RINEW intervention is a group-based integrated nutrition, responsive stimulation, and WASH intervention with a goal to improve child development outcomes. The intervention is delivered in group sessions to pregnant women and mothers or primary caregivers of children under 24 months of age. The RINEW intervention was tested in a pilot cluster-randomized control study in Bangladesh, where the investigators found the intervention group had better self-reported knowledge and behavior related to early child development. The investigators aim to implement this intervention through the government health system in one sub-district of Bangladesh, and assess the feasibility of delivering the intervention in this way, as well as the uptake of the intervention in the target population. The facilitators will be trained by the study team, and the intervention will be implemented in community-level health centers, facilitated by government health workers.
The specific objectives of this work are to:
- Assess the feasibility (i.e. satisfaction of providers, perceived appropriateness of content and practicability of session delivery, population demand for sessions, quality and frequency of implementation, and preparedness of health system) of implementing the RINEW intervention through the government health system
- Identify barriers, facilitators/opportunities, and pathway for scale up of the RINEW intervention through government health system
- Assess the coverage of the intervention in the target population
- Assess the uptake of recommended behaviors in the target population
To reach these objectives the investigators will
- Train government health workers to deliver the intervention at government health facilities
- Conduct a clinic-based process evaluation using both quantitative and qualitative methods at multiple time points during the 12-months intervention
- Conduct population-based quantitative baseline and endline assessments to assess intervention coverage and uptake
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants able to access the intervention | – | Behavioral: Integrated child stimulation, nutrition, lead, arsenic, WASH interventionThese group sessions will be delivered by government health workers, and include behavioral recommendations about responsive stimulation, nutrition, water, sanitation and hygiene, lead poisoning prevention, and maternal mental health. Pregnancy groups and caregiver-child groups will be held separately, and mothers and caregivers who attend sessions will receive simple toys and books to use during some of the intervention sessions, which they will be permitted to take home with them. In addition, mothers and caregivers who attend intervention sessions will receive 30 sachets containing 1 gm multiple micronutrient powder (MNP) per month. Beginning as soon as pregnancy is confirmed, health workers will facilitate pregnant women in receiving the Iron and Folic acid supplements already provided by the Government of Bangladesh and will continue the supplementation up to three months post-partum period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chatmohar sub-district of Pabna has been selected to implement the integrated intervention through the government system. All Chatmahor residents with children <2 or families of pregnant women are eligible to participate (attend health facilities offering the intervention) The selection of Chatmohar was based on meeting the following criteria: i. Communication status from Dhaka: should have a good by road communication (Bus/train) ii. Presence of a local champion in the government health system: UH\&FPO should be known and enthusiastic to implement an integrated intervention in the sub-district iii. Low percentage of vacant posts for government frontline health workers: <25% vacant posts iv. Most of the community clinic should be active v. Receptive and less conservative community vi. Community that is exposed to arsenic and lead contamination
Key inclusion criteria (4 listed)
- 1) Government health workers who are participating in the facilitation or supervision of RINEW sessions
- Inclusion criteria for qualitative interviews with intervention attendees 1) Mothers or primary caregivers eligible for the intervention sessions
- Exclusion criteria for qualitative interviews with intervention attendees
- 1) Child, mother, or primary caregiver with impaired cognitive development, or hearing, vision, speech impaired child or mother
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Integrated child stimulation, nutrition, lead, arsenic, WASH interventionThe content of the intervention curriculum was developed considering the needs of the specific ages of the children attending the group, as well as the feasibility of delivering the package in the community. The pregnancy module encompasses information on significance of prenatal care for child development, physiological symptoms and solutions, maternal diet, education on kangaroo mother care (KMC), breast feeding, thinking healthy, hygiene, and lead and arsenic prevention. The curriculum for lactating mothers focuses on specialized messages for 4 age groups of children: 0-5 months, 6-11 months, 12-18 months and 19-24 months. The overall package includes information regarding WASH, psychosocial stimulation, nutrition, maternal mental health, lead and arsenic. As research evidence showed that psychosocial stimulation provided for 10 or 12 months can significantly improve child development, the psychosocial stimulation component is included in every fortnightly session. | Behavioural | Participants able to access the intervention |
Primary outcome
Change in session quality
Time frame: 2nd, 6th and 12th month of the intervention; ~60 min per assessment
Semi-structured checklist for one pregnancy session and one mother-baby session in each health facility per assessment time period.
Change in proportion of planned session conducted
Time frame: Every 2 weeks through study completion; ~10 min
This data will be reported by the intervention facilitators and collected by the intervention supervisors on a monthly basis.
Change in number and proportion of eligible pregnant women and mother attendees at each session
Time frame: Monthly through study completion; ~15 min/assessment
The attendance numbers will be collected at each pregnancy and mother-baby session, and reported to the study team on a monthly basis.
Change in satisfaction of trained health workers with training and intervention implementation: Semi-structured individual interviews and focus group discussions
Time frame: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
Semi-structured individual interviews and focus group discussions with intervention implementors and their supervisors.
Change in determinants of session quality
Time frame: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
Semi-structure individual interviews and focus group discussions with a purposive sample of intervention implementors, their supervisors, and intervention attendees
Change in determinants of session attendance
Time frame: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
Semi-structure individual interviews and focus group discussions with a purposive sample of intervention implementors, their supervisors, and intervention attendees
9 secondary outcomes
Change in individual-level attendance records and self-reports
Time frame: Monthly through study completion; ~3 min/assessment
Change in caregiver early child development knowledge and practices
Time frame: Baseline and 12 months after intervention; ~15 min/assessment
Change in child dietary diversity, child minimum meal frequency and minimum acceptable diet.
Time frame: Baseline and 12 months after intervention; ~15 min/assessment
Change in maternal dietary diversity
Time frame: Baseline and 12 months after intervention; ~5 min/assessment
Change in maternal depressive symptoms
Time frame: Baseline and 12 months after intervention; ~5 min/assessment
Change in maternal knowledge regarding lead, nutrition, WASH, and arsenic
Time frame: Baseline and 12 months after intervention; ~5 min/assessment
Change in self-reported behaviour regarding prevention of lead contamination, disposal of human and chicken feces, water and food storage
Time frame: Baseline and 12 months after intervention; ~5 min/assessment
Change in availability and accessibility of safe water storage containers, hygienic toilet, handwashing station, child potty (for >6 months to 2 year old children), and covers for cooked food.
Time frame: Baseline and 12 months after intervention; ~5 min/assessment
Change in responsive feeding and interactions during mealtime
Time frame: Baseline and 12 months after intervention; ~5 min/assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 40685160Sultana J, Pitchik HO, Shoab AK, Huda TMN, Hasan R, Akter F, Jahir T, Khobair Hossain M, Das JB, Amin MR, Yeasmin F, Khan R, Forsyth JE, Kwong LH, Rashid J, Ashrafee S, Rahman M, Mridha MK, Tofail F, Winch PJ, Luby SP, Fernald LCH. Evaluation of a multicomponent child development intervention delivered through the government health system: a feasibility study. BMJ Glob Health. 2025 Jul 20;10(7):e018736. doi: 10.1136/bmjgh-2024-018736.
- Derived from this study: PubMed 37312017Winters S, Pitchik HO, Akter F, Yeasmin F, Jahir T, Huda TMN, Rahman M, Winch PJ, Luby SP, Fernald LCH. How does women's empowerment relate to antenatal care attendance? A cross-sectional analysis among rural women in Bangladesh. BMC Pregnancy Childbirth. 2023 Jun 13;23(1):436. doi: 10.1186/s12884-023-05737-9.
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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.
Stephen P Luby, Dr. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Childhood Development, run by Stanford University 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 4 inclusion and 0 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: finished, as of the sponsor's last update on 17 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in session quality (time frame: 2nd, 6th and 12th month of the intervention; ~60 min per assessment). 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 NCT04111016, which also lists 2 linked publications.
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 17 May 2022; AzTrials last refreshed its copy on 5 Nov 2026.