Congenital Heart DiseaseCHDNCT02389491
Effect of a High Density Formula on Growth and Safety in Congenital Heart Disease Infants
A study testing normal density formula (Necocate) and high density formula(Infatrini) in people with Congenital Heart Disease, run by Children's Hospital of Fudan University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- normal density formula (Necocate) and high density formula(Infatrini)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- normal density formula (Necocate), high density formula(Infatrini)
- Keywords
- high density formula, heart defects, infant
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal density formula (Necocate)Dietary supplement
In control group,there are 32 infants
high density formula(Infatrini)Dietary supplement
In intervention group,there are 32 infants
| Study group | Role | What they receive |
|---|---|---|
| normal density formula (Neocate) | Active comparator | In control group,infants intake normal density formula (Neocate,67kcal/100ml) when starting enteral nutrition after operation and continue for 7days Receives: Dietary Supplement: normal density formula (Necocate) |
| high density formula (Infatrini) | Experimental | In the intervention group,infants intake high density formula (Infatrini, 100kcal/100ml) when starting enteral nutrition after operation and continue for 7days Receives: Dietary Supplement: high density formula(Infatrini) |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain at the 7th day (g)
the 7th day body weight minus baseline body weight
Measured: from the first day starting enteric feeding to the 7th days
the number of participants with feeding intolerance
Feeding intolerance means participants have gastric retention, vomiting, diarrhea ect. lead to enteric feeding was stopped.
Measured: from the first day starting enteric feeding to the 7th day
Secondary outcomes (4)
Duration of mechanical ventilation
evaluate the long term effect of feeding high density formula
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
length of Cardiac Intensive Care Unit(CCU) stay
evaluate the long term effect of feeding high density formula
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
the number of participants with poor wound healing
evaluate the long term effect of feeding high density formula
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
the number of participants with necrotizing enterocolitis
evaluate the long term effect of feeding high density formula
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gu Ying, docter, Study chair, Children Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389491
- Sponsor's protocol ID
- FNF201426
- Acronym
- CHD
- Status last verified
- Nov 2015
- First submitted
- 5 Feb 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02389491
- Acronym / sponsor ID
- CHD / FNF201426
- Conditions
- Congenital Heart Disease
- Keywords
- high density formula, heart defects, infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal density formula (Neocate) | Active comparator | Dietary Supplement: normal density formula (Necocate)In control group,infants intake normal density formula (Neocate,67kcal/100ml) when starting enteral nutrition after operation and continue for 7days |
| high density formula (Infatrini) | Experimental | Dietary Supplement: 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 |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal density formula (Necocate)In control group,there are 32 infants | Dietary supplement | normal density formula (Neocate) |
| high density formula(Infatrini)In intervention group,there are 32 infants | Dietary supplement | high density formula (Infatrini) |
Primary outcome
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
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.
4 secondary outcomes
Duration of mechanical ventilation
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gu Ying, docter study chair
Children Hospital of Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing normal density formula (Necocate) and high density formula(Infatrini) in people with Congenital Heart Disease, run by Children's Hospital of Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight gain at the 7th day (g) (time frame: from the first day starting enteric feeding to the 7th days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.