Do you plan to exclusively formula feed your baby?
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Age from 18 up to and including 99
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Do you plan to exclusively formula feed your baby?
Are you expecting a baby within the next 6 months or is your baby under 14 days old and do you plan to exclusively formula feed you baby? If so, you may be eligible to participate in a research project with an investigational infant formula. You will receive infant formula and diapers at no cost plus compensation for your time.
What is the HUGS study?
We believe the best diet for an infant is breast milk, because it provides a complete set of nutrients for growth and development, as recommended by the WHO. Sometimes a mother is unable to or chooses not to breastfeed. In such cases, infant formula is the best alternative. Good nutrition is vital for healthy growth and development for an infant during the first years in life. Danone Nutricia Research has developed a new infant formula. A study will be conducted to investigate the growth and health of infants who drink this investigational formula versus a standard, commercially available infant formula.
This study will be conducted with infants younger than 2 weeks old until they are about 19 weeks old. If you choose to participate, you will receive study infant formula and diapers throughout the duration of the study. You will be asked to bring your infant to the clinic on several occasions to monitor his/her growth and health. You will also be asked to complete a diary of your infant’s daily activities, including feeding and bowel movements. You will be compensated for your time and travel.
Who can take part?
Your child can join the HUGS study if:
- He/she is under 14 days old at the start of the study
- You are planning to exclusively formula feed your baby for the duration of the study (4 months)
What will I be asked to do in this research study?
If you decide for your infant to take part in this study:
- You will feed your infant with the assigned study infant formula for 16 weeks (4 months). During this period, you and your infant will come into the clinic for study visits 6 times.
- In between each visit you will be asked to keep a diary for in total 7 of the 16 weeks. In the diary you will record feeding patterns, the number of stools your infant has and stool consistency, if your infant vomits or regurgitates, as well as infections your infant has, should these occur. Each time you come to the clinic, the information you recorded in the diary will be reviewed with you.
- Two weeks after the last visit, you will receive a telephone call from the study staff to enquire about the wellbeing of your infant.
- If you consent to provide stool samples, you will collect a stool sample from your infant’s diaper in a tube and will bring the sample to the study visit 3 times during the study. You will be asked to store the tube in your freezer and bring it with you to your next study visit.
How long will my infant be involved in this research study?
You and your infant’s participation in this study will last approximately 18 weeks (4 ½ months).
You will receive:
- Your child will receive infant formula at no cost to you. This will be either the new infant formula or a standard, commercially available infant formula;
- Your child will be monitored closely by a qualified physician throughout the study;
- You will be paid up to a total of $600.00 if you complete this study. You will be paid $100.00 for each visit (Visit 1 to 6);
- Diapers for your infant will be provided at no cost for your convenience and to thank you for your study efforts.
How to apply
If you are interested in finding out more about the study and whether you and your baby may be able to take part, please register without obligation on this website and complete the questions below.
If you are eligible, we will contact you to schedule a telephone appointment, and will also be happy to answer any questions you may have.
What is the purpose of the research study?
The main purpose of this study is to demonstrate whether or not infants who receive the new study formula for 16 weeks (4 months) have similar growth and health compared to infants receiving a standard, commercially available infant formula.
It is accepted that the best nutrition for a young infant is breast milk. Breast milk provides a complete set of nutrients to support growth and development of infants in early life. It contains components that have a beneficial effect on gut health and the body’s ability to defend itself against infections and other diseases.
Therefore, Danone Nutricia Research advises exclusive breastfeeding for infants. The World Health Organization and American Academy of Pediatrics also recommend exclusive breastfeeding up to 6 months of age.
Sometimes a mother is unable to breastfeed her infant or chooses not to breastfeed. In such cases, an infant formula is the best alternative. You are asked to participate in this study because your infant is currently being fed infant formula and you have the intention to continue to exclusively feed infant formula until 18 weeks of age. Research studies like this one are being conducted around the world to gain more knowledge and to constantly improve infant formulas.
The study will be carried out in approximately 25 study clinics in the U.S. A total of approximately 206 infants will take part in this study. The results of the study will be submitted to the U.S. Food and Drug Administration for review.
The Sponsor, named ‘Danone Nutricia Research’, is paying for this research study. Your infant’s study doctor will be paid by the Sponsor to conduct this study.
What is the research study product being investigated?
Two infant formulas (also referred to as “study products”), will be compared in this study:
- Study formula: an infant formula with prebiotics and probiotics and;
- Commercially available formula: a standard infant formula available in stores in the U.S. with prebiotics only
Prebiotics are a mixture of fibers that naturally survive the digestive process to feed the “good” bacteria (probiotics) present in your gut, conferring a health benefit.
Probiotics are naturally present in your gut but they can also be added to your diet and this can help populate the gut with good bacteria.
The study formula has slight differences in nutrient levels from the commercially available formula. Both infant formulas used in this study provide complete nutrition needed to support appropriate growth in healthy, term infants.
Rest assured that none of the study products or its manufacturing facilities are involved in or associated with any infant formula recall.
A computer program will assign your infant to the study formula group or the commercially available formula group “by chance.” Your infant has a 50% chance (like flipping a coin) of receiving either the study formula or the commercially available formula. You or your study doctor cannot choose your infant’s study group. During the study, neither you nor the study doctor will know to which group your infant is assigned. Your study doctor can find out in case of an emergency.
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