Human Milk Derived Fortifier for Heart Defects, Congenital
This study is evaluating whether human milk is better than formula for infants with single ventricle physiology.
See full descriptionAbout the trial for 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.
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.
Approximate Timelines
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.
Patient Q & A Section
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.