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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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12 December 2020 |
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Main ID: |
NCT03366584 |
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Date of registration:
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03/12/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of ß-Carotene, Vitamin D3 and Zinc on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates
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Scientific title:
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The Effect of Co-administered ß-Carotene, Vitamin D3, Zinc and Antenatal Steroid Therapy on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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120 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03366584 |
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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: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Yuyun Lisnawati |
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Address:
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Telephone:
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Email:
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Affiliation:
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Persahabatan General Hospital |
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Name:
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Yuyun Lisnawati, Consultant |
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Address:
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Telephone:
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+628161841987 |
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Email:
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yulisna.er@gmail.com |
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Affiliation:
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Name:
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Yuyun Lisnawati |
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Address:
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Telephone:
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Email:
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yulisna.er@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pregnant women who has preterm birth in 28-34 weeks gestational age
Exclusion Criteria:
- Multiple pregnancy
- Drug allergy
- Fetal congenital malformation
- Maternal gestational diabetes mellitus
Age minimum:
17 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hyaline Membrane Disease
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Necrotizing Enterocolitis of Newborn
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Intervention(s)
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Dietary Supplement: Zinc
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Drug: Dexamethasone
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Dietary Supplement: Beta carotene
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Dietary Supplement: Vitamin D3
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Primary Outcome(s)
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Hyaline membrane disease
[Time Frame: 1,5 years]
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Secondary Outcome(s)
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Feeding Intolerance
[Time Frame: 1,5 years]
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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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