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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02663453 |
Date of registration:
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11/01/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
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Scientific title:
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Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition: A Two-Center, Double-Blind Randomized Clinical Trial |
Date of first enrolment:
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December 2013 |
Target sample size:
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44 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02663453 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Contacts
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Name:
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Wilaiporn Techasatid, doctor |
Address:
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Telephone:
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Email:
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Affiliation:
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Department of Pediatrics, Faculty of Medicine, Thammasat University, 95 Paholyothin Road, Klongluang, Pathumthani, 12120 Thailand. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Inborn infants with a gestational age of less than 30 weeks
- Who required parenteral nutrition for at least 7 days
Exclusion Criteria:
- Evidence of congenital infection
- Perinatal asphyxia
- Congenital anomalies
- Severe IVH
- Thrombocytopenia
- Shock or circulation failure
- Renal or hepatic disorders.
Age minimum:
24 Weeks
Age maximum:
30 Weeks
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cholestasis
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Intervention(s)
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Drug: multicomponent lipid emulsion
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Drug: pure soybean oil lipid emulsion
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Primary Outcome(s)
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Incidence of Neonatal Cholestasis
[Time Frame: 3 months]
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Secondary Outcome(s)
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Incidence of Extrauterine Growth Restriction (EUGR)
[Time Frame: up to 24 weeks]
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Assessment of Gamma Glutamyltranspeptidase (GGT)
[Time Frame: 3 month]
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Head Circumference Gain
[Time Frame: up to 24 weeks]
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Assessment of Aspartate Aminotransferase (AST)
[Time Frame: 3 month]
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Weight Gain
[Time Frame: up to 24 weeks]
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Assessment of Alanine Aminotransferase (ALT)
[Time Frame: 3 month]
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Height Gain
[Time Frame: up to 24 weeks]
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Neonatal Morbidities
[Time Frame: 4 months]
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Secondary ID(s)
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MTU-EC-PE-1-033/56
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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