BOND

(In Start Up)

About This Study

When babies have congenital heart disease (CHD), doctors usually find out during pregnancy or soon after birth. This is often surprising and stressful for families, and many need support. The BOND study is being done to find new ways to support mothers and their babies after CHD diagnosis. The BOND study has two parts. One part, HeartGPS, will look at how a new emotional support program may help mothers adjust to their baby’s diagnosis during pregnancy and after birth. The second part, Direct Breastfeeding will look at how to support mothers who breastfeed. Both parts will look at how these support programs may improve the well-being of mothers and the bond between mother and baby. You may be eligible to participate in both study parts or only one part.

Study Locations

Click on a pin to see study site location details

HeartGPS Study Details

The main reason for this study part is to learn if HeartGPS is helpful for families when it is added to the usual care offered at their heart center. The HeartGPS program provides emotional support for parents after prenatal diagnosis of congenital heart disease.

Direct Breastfeeding Study Details

Babies with serious heart problems (CHD) often face challenges with feeding, and we know that good nutrition is a key part of their recovery. Babies born with CHD can receive nutrition in several ways including breastmilk or formula.

This study part is focused on understanding all types of feeding choices—whether you choose breastfeeding, formula, or a combination—and how nutrition impacts babies with CHD. We also want to understand how your baby’s feeding journey affects you. We are collecting information to help us learn how to improve the overall nutrition and care of children born with CHD.

Direct breastfeeding may be helpful in babies with CHD to lower their number of medical problems. Direct breastfeeding may also help with mother and baby bonding. Besides the health benefits for the baby, breastfeeding can also be good for mothers’ emotional well-being. The main purpose of this study part is to find ways to help more mothers with direct breastfeeding and see how this affects the health and well-being of both mother and baby

Pregnant women that receive a prenatal diagnosis of congenital heart disease.

The study will be explained to you in detail by one of the study investigators. Once your questions have been answered, you will be asked to provide consent to enter the study.

These are the things that will happen during the study if you choose to participate. You will be asked to:

  • Fill out online surveys at five different times. Surveys will ask questions about your emotional, behavioral, and physical health and well-being. They will also ask questions about your thoughts, feelings, and experiences since finding out about your baby’s heart condition. These surveys take an average of 23 – 45 minutes to complete.
  • Provide saliva samples at two different times. You will also fill out a short form with questions about your general health and recent events.
  • Provide a blood sample from you and your baby
  • Assessment of your baby’s development: When your baby is about 12 months old, he or she will take part in an activity called the Bayley Scales of Infant Development. This activity is designed to help us learn more about babies’ development. During this activity, your baby will take part in play tasks to help us learn about their interest in familiar and unfamiliar objects, and to see how your baby plays with different types of toys. The whole activity will be completed with a trained member of the study team at your heart center and will take about 60 minutes.
  • Participate in a short (5 minute) play activity with your baby at your heart center when your baby is about 12 months old.
  • If you are assigned randomly to receive the HeartGPS program, you will participate in 8 telehealth sessions with a psychologist, and have 2 additional check-in sessions.

The study begins in pregnancy and ends when baby is about 12 months old.

A Pregnant Mother: Your unborn baby has a heart condition (CHD) and will need to stay at a heart center after birth and is expected to need heart surgery or a special heart procedure, a cardiac catheterization, in the first month of life.

OR

A Mother of a Newborn: Your baby was diagnosed with CHD after birth, was admitted to the hospital in the first week of life, and is expected to need a heart procedure by one month of age.

The study will be explained to you in detail by one of the study investigators. Once your questions have been answered, you will be asked to provide consent to enter the study.

These are the things that will happen during the study if you choose to participate. You will be asked to:

  • Fill out online surveys at five different times. Surveys will ask questions about your emotional, behavioral, and physical health and well-being. They will also ask questions about your thoughts, feelings, and experiences since finding out about your baby’s heart condition. These surveys take an average of 23 – 45 minutes to complete.
  • Collect one small stool (poop) sample from your baby’s diaper at about 4 months of age.
  • Provide a blood sample from you and your baby.
  • Assessment of your baby’s development: When your baby is about 12 months old, he or she will take part in an activity called the Bayley Scales of Infant Development. This activity is designed to help us learn more about babies’ development. During this activity, your baby will take part in play tasks to help us learn about their interest in familiar and unfamiliar objects, and to see how your baby plays with different types of toys. The whole activity will be completed with a trained member of the study team at your heart center and will take about 60 minutes.

 

Your participation will end when baby is about 12 months old.

You may not receive any direct benefits to you or your child from being in this study. We hope that the information learned will help the families of babies who have CHD and others in the future.

You may experience risks or discomforts from the procedures that are required as part of the study:

  • Minor discomfort or distress while completing questionnaires
  • Loss of confidentiality
  • Minor discomfort while providing blood samples. There is a very small chance of pain, bruising, and bleeding where the needle goes into the skin.

Aside from your time, there are no costs for participating in this study. Your insurance will not be billed for any research-only activities. You will be responsible for your child’s normal medical care.