Growth FailureNCT01850784
High Energy Formula Feeding in Infants With Congenital Heart Disease
A study testing High energy formula and Standard formula in people with Growth Failure and Neurodevelopmental Disorder, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
High energy formula more positively affect growth in infants with congenital heart disease compared to standard formula Read more about this study
- Who is it for?
- Ages 8 days to 6 months
- Conditions the study is for
- Growth Failure, Neurodevelopmental Disorder
- What is being tested?
- High energy formula and Standard formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2013to Oct 2014
- 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 8 days to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants >35 weeks of gestational age
- infants with CHD
- İnfants fed with formula feeding
Who cannot join
- Major congenital abnormalities except CHD
- infants could not be fed enterally
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sami Ulus CH
Ankara
Nazan N Doğan, MD
Nazan N Doğan
About this study
High energy formula more positively affect growth in infants with congenital heart disease compared to standard formula
Read the detailed description
Infants with congenital heart disease (CHD) usually show growth retardation as they can not intake enough calorie due to fluid restriction. We hypothesize that high energy formula more positively affect growth in infants with congenital heart disease compared to standard formula
- Conditions
- Growth Failure, Neurodevelopmental Disorder
- Being tested
- High energy formula, Standard formula
- Keywords
- Congenital heart disease, Growth,Neurodevelopment
- Medical subject headings
- Failure to Thrive, Neurodevelopmental Disorders, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High energy formulaDietary supplement
Also called High energy formula (Similac)
The infants with CHD will be fed with high energy formula (Similac; 1kcal/ml)
Standard formulaDietary supplement
The infants with CHD will be fed with standard formula (0.6-0.7 kcal/ml)
| Study group | Role | What they receive |
|---|---|---|
| High energy formula | Active comparator | High energy formula (Similac) Receives: Dietary Supplement: High energy formula |
| Standard formula | Active comparator | Standard formula Receives: Dietary Supplement: Standard formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: 6 weeks
Secondary outcomes (1)
Neurodevelopmental evaluation
Neurodevelopmental evaluation will be assessed by Bayley-II Scale at corrected age of 12-18 months.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth FailureStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Sami Ulus Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Dilli, Dr. Sami Ulus Children's Hospital
- Investigators
- Dilek Dilli, Study director, Sami Ulus CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850784
- Sponsor's protocol ID
- 132/2013
- Status last verified
- May 2013
- First submitted
- 7 May 2013
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Energy Formula Feeding in Infants With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01850784
- Acronym / sponsor ID
- 132/2013
- Conditions
- Growth Failure, Neurodevelopmental Disorder
- Keywords
- Congenital heart disease, Growth,Neurodevelopment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dr. Sami Ulus Children's HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 9 May 2013 (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.
High energy formula more positively affect growth in infants with congenital heart disease compared to standard formula
Detailed description
Infants with congenital heart disease (CHD) usually show growth retardation as they can not intake enough calorie due to fluid restriction. We hypothesize that high energy formula more positively affect growth in infants with congenital heart disease compared to standard formula
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High energy formula | Active comparator | Dietary Supplement: High energy formulaHigh energy formula (Similac) |
| Standard formula | Active comparator | Dietary Supplement: Standard formulaStandard formula |
Who may qualify
- Ages
- 8 days to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- infants >35 weeks of gestational age
- infants with CHD
- İnfants fed with formula feeding
Key exclusion criteria (2 listed)
- Major congenital abnormalities except CHD
- infants could not be fed enterally
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 |
|---|---|---|
| High energy formulaAlso: High energy formula (Similac)The infants with CHD will be fed with high energy formula (Similac; 1kcal/ml) | Dietary supplement | High energy formula |
| Standard formulaThe infants with CHD will be fed with standard formula (0.6-0.7 kcal/ml) | Dietary supplement | Standard formula |
Primary outcome
Weight gain
Time frame: 6 weeks
1 secondary outcome
Neurodevelopmental evaluation
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
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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.
Dilek Dilli study director
Sami Ulus CH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High energy formula and Standard formula in people with Growth Failure and Neurodevelopmental Disorder, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilek Dilli, Assoc Prof (00903126243, dilekdilli2@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain (time frame: 6 weeks). 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 May 2013.