| Extremely
Low Gestational Age Newborns (ELGANs)
are infants born more than 3 months early. They are more likely to develop
certain health and development problems than babies who are not born prematurely.
The ELGAN study is an effort to find out why some very premature infants
are more likely than others to have these problems.
In the ELGAN study, we want to observe
and identify the earliest signs of problems. This may help us learn how
to prevent difficulties in babies such as yours.
Only a small number of very premature
infants develop each kind of health problem. This means that we must observe
and follow the progress of a large number of premature babies to find
each problem we want to study. For this reason, the ELGAN study needs
to enroll more than 1,800 very premature infants.
Before enrolling yourself and your baby, you should
know the following
Enrolling in the study will not change
anything at all about your baby's medical care, which is directed by his
or her doctors.
You will be interviewed briefly about
yourself and your present and past pregnancies.
Your own and your infant's medical
records will be reviewed for information about medical care.
A drop of your blood will be collected
at selected times, but only when blood is being collected as part of your
medical care.
A drop of your baby's blood will be
collected at selected times, but only when blood is being collected as
part of your baby's medical care.
A piece of your placenta and your baby's
umbilical cord are examined routinely as part of regular medical care
and then they are discarded. We want to save them and study them.
After your baby is discharged from
the hospital, you will receive occasional mailings and telephone calls
from us to keep you informed about the ELGAN study.
At no cost to you, we can assess your
child's development at one and two years of age after you sign another
consent form.
All information is kept strictly confidential
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