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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00715936 |
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Date of registration:
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14/07/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Pakistan Early Childhood Development Scale Up Trial
PEDS |
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Scientific title:
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Phase 1 Study of Integration of Early Child Development Interventions in a Community Health Service in Sindh, Pakistan |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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1489 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00715936 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Aisha K Yousafzai, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aga Khan University |
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Name:
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Zulfiqar A Bhutta, MBBS, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Aga Khan University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All children born in the defined geographical area of study during the study
enrollment period will be eligible for the study along with their primary care giver
(mother). Infant must be 1d-2.5m of age at time of enrolment.
Exclusion Criteria:
- Children born with profound severe disabilities
Age minimum:
N/A
Age maximum:
24 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Early Child Development and Growth
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Intervention(s)
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Behavioral: ECD
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Behavioral: Enhanced Nutrition
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Behavioral: Control
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Primary Outcome(s)
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Early Child Development
[Time Frame: 24 months of child age]
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Child Growth
[Time Frame: 24 months of child age]
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Secondary Outcome(s)
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Caregiving Mediator: Mother/Child Interaction
[Time Frame: 12 months and 24 months of child age]
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Morbidity
[Time Frame: Monthly report]
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Caregiving Mediator: Feeding Practices
[Time Frame: Baseline, 6 months, 12 months, 18 months and 24 months of child age]
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Caregiving mediators: Caregiving Environment
[Time Frame: 6 months and 18 months of child age]
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Caregiving Mediators: Maternal Psychological Distress (Depression)
[Time Frame: Baseline, 6 months, 12 months, 18 months and 24 months of child age]
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Anaemia Status
[Time Frame: 24 months child age]
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Caregiving Mediator: Care for Development
[Time Frame: Baseline, 12 months and 24 months of child age]
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Secondary ID(s)
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993-PEDS/ERC-08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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