CLINICAL TRIAL

Human Milk Derived Fortifier for Heart Defects, Congenital

Waitlist Available · < 18 · All Sexes · Chicago, IL

This study is evaluating whether human milk is better than formula for infants with single ventricle physiology.

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About the trial for Heart Defects, Congenital

Eligible Conditions
Univentricular Heart · Heart Defects, Congenital · Heart Defects,Congenital

Treatment Groups

This trial involves 2 different treatments. Human Milk Derived Fortifier is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Human Milk Derived Fortifier
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Human/Bovine Milk
OTHER

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Parents who are willing to comply with the study's follow-up procedures. show original
The policy recommends that surgery be performed to palliate the infant within the first month of life. show original
Infants born at least 37 weeks gestation and 7 days old who are diagnosed with a single ventricle and are likely to need surgery to fix the problem. show original
Infant feeding was NPO or consisted of 100% human milk diet prior to enrollment
Parents who are willing to sign an informed consent form. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to 24 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Human Milk Derived Fortifier will improve 1 primary outcome and 9 secondary outcomes in patients with Heart Defects, Congenital. Measurement will happen over the course of 30 days.

wound dehiscence
30 DAYS
wound dehiscence 30 days post 1st operation
30 DAYS
parenteral nutrition
30 DAYS
in days, during the 30 day post 1st operation
30 DAYS
Feeding Intolerance
30 DAYS
defined as nil per os (NPO) for at least 24 in the 30 days of post-surgery enteral feeding period (day 1 is the first day of feeding post-op), NPO due to elective surgeries or procedures will not be defined as feeding intolerance.
30 DAYS
wound infections
30 DAYS
wound infection 30 days post 1st operation
30 DAYS
growth velocity
30 DAYS
weight z-score 30 days post 1st operation
30 DAYS
Sepsis
30 DAYS
Sepsis 30 days post 1st operation
30 DAYS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get heart defects, congenital a year in the United States?

Recent findings estimates the lifetime odds of having an CHD in one in 1,050 for US males and 1 in 1,090 for females. Of the estimated 3 billion Americans, 7% are estimated to have CHDs each year.

Anonymous Patient Answer

What causes heart defects, congenital?

There are two reasons why heart defects occur more than other types of birth defects; (1) they are usually the easiest and cheapest to diagnose, and (2) they are more easily detected by an obstetrician. However, the cause is always due to genetics. It is important to find out if the parents are genetically ready or not. A genetic test is not always available but there are some doctors, clinics, hospitals, and organizations that specialize in test results and genetic counseling. An extra resource on genetics is available at: http://www.ncbi.nlm.nih.gov/pubmed. In a healthy baby there are many cells and DNA.

Anonymous Patient Answer

What is heart defects, congenital?

Congenital heart disease is a group of defects that adversely affect the heart structure, the blood circulatory system, or both at birth. They also greatly affect all aspects of a person's life, making them unique subjects of study, treatment and prevention of heart defects.

Anonymous Patient Answer

What are the signs of heart defects, congenital?

Signs of heart defects are usually related to severity of the heart defect. Signs of heart defects can be divided into nonstructural (congenital heart defects are the majority) and structural (dilated and weakened heart). Common heart defects signs are:\n1. Sudden infant deaths\n2. Cyanosis and low oxygen saturation\n3. Cardiac murmurs\n4. Stridor\n5. Facial and cervical masses of tumors\n6. Swollen joints owing to osteoporosis.\n7. Heart murmurs\n8.

Anonymous Patient Answer

Can heart defects, congenital be cured?

Cardioventricular anomalies may be effectively treated within 2 months of birth. Early detection and effective treatment is essential, but this is not the most important determinant of survival or the rate with which these anomalies are resolved.

Anonymous Patient Answer

What are common treatments for heart defects, congenital?

For many conditions, therapy is directed towards correcting the underlying physiology of the defect. However, for some, e.g. congenital stenoses of the pulmonary vein ostia, definitive relief may be provided by the use of catheters to treat the defect through direct implantation of a prosthetic patch.

Anonymous Patient Answer

What is the latest research for heart defects, congenital?

A large portion of current research deals with heart defects, congenital in nature. It is most likely these disorders will continue to be the priority areas of research and treatment because the underlying causes are now widely understood. The advancement in genetic research has also opened up many new possibilities in treatment.

Anonymous Patient Answer

Is human milk derived fortifier typically used in combination with any other treatments?

Despite the wide usage for HMDF, there is no high quality evidence available for the combined use of HMDF with other treatments. If any evidence of safety and efficacy exists, it is mostly of low quality and is derived from studies with small sample sizes. In particular, there is a lack of high quality evidence specifically on the combination of HMDF with parenteral glucose solutions, where the most common use is in preterm infants. Overall there is no evidence on the use of HMDF in combination with other treatments.

Anonymous Patient Answer

How serious can heart defects, congenital be?

As the survival rate of congenital heart defects patients improves, more adults with heart defects will be alive, living long enough to have children. Results from a recent paper shows the necessity of being aware of life-threatening complications of heart defects due to their serious nature and severity.

Anonymous Patient Answer

What are the common side effects of human milk derived fortifier?

In this population-based cohort of women who breastfed within the first 5 months of life, there was no association between human milk derived fortifier and the severity of allergic diseases or adverse developmental outcomes.

Anonymous Patient Answer

What is the primary cause of heart defects, congenital?

A majority of children with heart defects had no known family history of heart disease, suggesting that they were not related to a single mutation, and that at least some of these cases represent new mutations.

Anonymous Patient Answer

What is the average age someone gets heart defects, congenital?

There is an association between low levels of socioeconomic status and the age of onset of heart defects. As a result, public policies directed toward achieving more equitable access to health care should focus not only upon achieving universal coverage of primary care, but also on improving access to diagnostic equipment for those with heart defects.

Anonymous Patient Answer
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