Effect of a High Density Formula on Growth and Safety in Congenital Heart Disease Infants
NCT ID: NCT02389491
Last Updated: 2015-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2015-03-31
2015-10-31
Brief Summary
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Detailed Description
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The current study adopts randomized,controlled intervention trial, gives high density formula(Infatrini,100kcal/100ml)to CHD infants in intervention group and normal density formula（Neocate,67kcal/100ml）in control group. Intervention begins when infants start enteral nutrition after operation and continues for 7days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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normal density formula (Neocate)
In control group,infants intake normal density formula (Neocate,67kcal/100ml) when starting enteral nutrition after operation and continue for 7days
normal density formula (Necocate)
In control group,there are 32 infants
high density formula (Infatrini)
In the intervention group,infants intake high density formula (Infatrini, 100kcal/100ml) when starting enteral nutrition after operation and continue for 7days
high density formula(Infatrini)
In intervention group,there are 32 infants
Interventions
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normal density formula (Necocate)
In control group,there are 32 infants
high density formula(Infatrini)
In intervention group,there are 32 infants
Eligibility Criteria
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Inclusion Criteria
2. aged from 1 day to 12 months
3. accept extracorporeal circulation open-heart surgery
4. family members voluntarily participate in this study
Exclusion Criteria
2. accept total parenteral nutrition
3. predicted the length of CCU stay is less than five days
4. patients have abdominal distention, diarrhea, vomiting
1 Day
12 Months
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Gu Ying, docter
Role: STUDY_CHAIR
Children Hospital of Fudan University
Other Identifiers
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FNF201426
Identifier Type: -
Identifier Source: org_study_id
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