Effect of a High Density Formula on Growth and Safety in Congenital Heart Disease Infants (CHD)
November 9, 2015 updated by: Children's Hospital of Fudan University
Effect of a High Density Formula on Growth and Safety in Early Postoperative Infants With Congenital Heart Disease Duration of Cardiac Intensive Care Unit（CCU）Stay: a Randomized Clinical Trial
The purpose of this study is to explore the effects of high density formula in early postoperative infants with congenital heart disease and to assess its safety.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The number of infants born with CHD increases every year and most CHD infants are suffered with malnutrition.Recent studies have shown that increasing energy intake in CHD infants can improve their nutrition status.But there are no high qualified evidences supporting that high density formula can promote infants' nutrition status and ensure its safety. The hypothesis of the current study is that high density formula intake can increase infants'weight and it's safe.
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.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of congenital heart disease from symptoms, signs, ultrasonic and imaging examination
- aged from 1 day to 12 months
- accept extracorporeal circulation open-heart surgery
- family members voluntarily participate in this study
Exclusion Criteria:
- patients have other diseases which cause nutrition disorders, such as gastrointestinal malformation, preoperative gastroesophageal reflux, genetic diseases related to the growth restriction
- accept total parenteral nutrition
- predicted the length of CCU stay is less than five days
- patients have abdominal distention, diarrhea, vomiting
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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
|
In control group,there are 32 infants
|
|
Experimental: 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
|
In intervention group,there are 32 infants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
weight gain at the 7th day (g)
Time Frame: from the first day starting enteric feeding to the 7th days
|
the 7th day body weight minus baseline body weight
|
from the first day starting enteric feeding to the 7th days
|
|
the number of participants with feeding intolerance
Time Frame: from the first day starting enteric feeding to the 7th day
|
Feeding intolerance means participants have gastric retention, vomiting, diarrhea ect.
lead to enteric feeding was stopped.
|
from the first day starting enteric feeding to the 7th day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of mechanical ventilation
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
|
evaluate the long term effect of feeding high density formula
|
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
|
|
length of Cardiac Intensive Care Unit(CCU) stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
|
evaluate the long term effect of feeding high density formula
|
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
|
|
the number of participants with poor wound healing
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
|
evaluate the long term effect of feeding high density formula
|
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
|
|
the number of participants with necrotizing enterocolitis
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
|
evaluate the long term effect of feeding high density formula
|
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Gu Ying, docter, Children Hospital of Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
February 5, 2015
First Submitted That Met QC Criteria
March 16, 2015
First Posted (Estimate)
March 17, 2015
Study Record Updates
Last Update Posted (Estimate)
November 10, 2015
Last Update Submitted That Met QC Criteria
November 9, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FNF201426
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.