Child MortalityNCT00656591
Community-Based Interventions for Infant Health in Nepal
An observational study of Child Mortality, run by Institute of Child Health at 1 site in United Kingdom.
Trial summary
An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for Pregnant Women in Nepal to Reduce Fetal \& Infant Mortality and to Improve Fetal Growth \& Cognitive Development in Infancy Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Child Mortality
- What is being tested?
- Methotrexate
- How many people
- 192,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2005to Dec 2008
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 48 village development committee areas
Who may be able to join
- mothers, community health volunteers
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
International Child Health, ICH
London, WC1N 1EH
Anthony Costello, Dr, a.costello@ich.ucl.ac.uk
About this study
Official title: An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for Pregnant Women in Nepal to Reduce Fetal and Infant Mortality, and to Improve Fetal Growth and Cognitive Development in Infancy.
An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for Pregnant Women in Nepal to Reduce Fetal \& Infant Mortality and to Improve Fetal Growth \& Cognitive Development in Infancy
- Conditions
- Child Mortality
- Being tested
- Methotrexate
- Keywords
- Child mortality, Nepal, Community, care practices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Methotrexate
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal mortality rates
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startMar 2005
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MortalityStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 192,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Investigators
- Anthony Costello, Dr, Principal investigator, Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656591
- Sponsor's protocol ID
- 04PC01
- Status last verified
- Apr 2008
- First submitted
- 22 Dec 2006
- Last updated
- 11 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for Pregnant Women in Nepal to Reduce Fetal and Infant Mortality, and to Improve Fetal Growth and Cognitive Development in Infancy.
- ClinicalTrials.gov ID
- NCT00656591
- Acronym / sponsor ID
- 04PC01
- Conditions
- Child Mortality
- Keywords
- Child mortality, Nepal, Community, care practices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 192,000 participants (estimated)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 11 Apr 2008 (estimated)
- 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.
An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for Pregnant Women in Nepal to Reduce Fetal \& Infant Mortality and to Improve Fetal Growth \& Cognitive Development in Infancy
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 48 village development committee areas
Key inclusion criteria (1 listed)
- mothers, community health volunteers
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| MethotrexateMethotrexate | Drug | – |
Primary outcome
neonatal mortality rates
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2008.
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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.
Anthony Costello, Dr principal investigator
Institute of Child Health
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 Child Mortality, run by Institute of Child Health at 1 site in United Kingdom.
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 1 inclusion and 1 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 11 Apr 2008. 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 United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neonatal mortality rates (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2008.