Do you plan to exclusively formula feed your baby?

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:

  1. Study formula: an infant formula with prebiotics and probiotics and;
  2. 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.

  • Male
  • Female

You will receive an email which you must confirm

  • My child has not been born yet
  • My child is under 14 days old
  • My child is older than 14 days

  • Yes
  • No
  • Unsure
  • My child has not been born yet

  • Yes
  • No
  • Unsure

  • Yes
  • No
  • Unsure
  • My child has not been born yet

  • Yes
  • No
  • Unsure

  • I hereby give Link2Trials my consent to store the personal data I have provided in my personal profile and to process them for the purposes stated in the declaration of consent. View these here.

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    April 2022

    www.link2trials.us

     

    What data do we collect?
    When you register an account, you will be asked to fill out data.

    • We will request your name, address, postcode, and town/city to contact you; for example, to make appointments or send you information.
    • In addition, we will need your phone number to contact you and send you a reminder message.
    • To create your account, we will ask for your email address. We also need this information to contact you by email; for example, to send you confirmation and reminder emails. In addition, we send emails to inform you of any new trials.
    • We need your address, postcode, and town/city in order to display local trials or studies within a certain radius.
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    These personal data are necessary for the intended and actual performance of an agreement. Without this information, we will not be able to enter into an agreement or use you as a trial subject. In addition, we will ask you for your prior consent to process of this data.

    Research purposes: special personal data”
    In addition, certain information is requested for research purposes in order to see whether you are a match with the trial in question and to carry out the study. This information includes personal data with respect to your gender, age, medication use, fertility, height and weight, alcohol consumption, smoking habits, and other medical data and/or data concerning health.

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    Full privacy statement

    PRIVACY STATEMENT

    April 2022

    www.link2trials.com

     

    About us

    Link2Trials is the business that determines the means and purposes of the processing of your personal data within the meaning of the California Consumer Privacy Act (referred to hereinafter as: CCPA).

    What data do we collect and for what purposes?

    When you register an account, you will first be asked to fill in the following data:

    • To create your account, we will ask you for your email address and password.

    After confirming your email address, we will ask you to supplement your profile with the following information:

    • We will ask you for your name, address, postal code and place of residence so we can contact you, for instance to arrange appointments or to send information.
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    • Your IP address is processed to protect your account.
    • We also need your already-stored email address to contact you by email, for example to send confirmation and reminder emails. We also send emails to alert you to new studies.

    In addition, certain special personal data are requested for research purposes, in order to assess whether you match the requirements applying to the relevant study and to subsequently conduct the study with you. The data that may be requested for research purposes include personal data relating to your gender, age, use of medication, fertility, height and weight, alcohol consumption, smoking behavior and other medical and/or health data.

    If you register for a specific study, part of the above data, including the data related to your health (special personal data), will be requested. After all, without these special data, we cannot match you with any of the available studies. The type and quantity of special personal data may vary per study, because we only collect the data necessary for that specific study.

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    In principle, your personal data will be retained until you cancel your account with us. When you cancel your account, the personal data will be deleted within 72 hours at the latest.

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    In this context, “written” includes by email. You can email your request to us via helpdesk@link2trials.com. We will process your request as soon as possible, but always within four weeks.

    You also have the right to submit a complaint about the way in which we handle your data. You can submit any such complaints to the Federal Trade Commission.

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