For years, obtaining parental consent for clinical research regarding newborn resuscitation in the delivery room has been a challenge. Now, a Saint Louis University pediatric researcher is asking new mothers and pregnant women when doctors should seek parental permission to allow medical research related to delivery room treatments.
Marya Strand, M.D., associate professor of pediatrics at Saint Louis University, has received a $45,000 grant from the Fleur de Lis Fund of SSM Cardinal Glennon Children's Foundation to study the public opinion on obtaining consent. Through this study, Strand and her team will try to find the best time to ask mothers to sign a consent form in order for the baby to participate in a delivery room study.
"Much of how we treat babies in the delivery room has not been studied, it is just how we have always done it," Strand said. "Some of the treatments we use need to be studied to make sure we are providing the best care to newborns."
About 10 percent of all babies require resuscitation after they are born, but only a portion of that group will be eligible for individual research studies.
Traditionally, clinical studies about best practices to care for troubled newborns require the mother's approval shortly after delivery. She either signs a form that authorizes her baby to be part of a specific medical research study or a form that waives consent, which could allow her baby to be placed in the study researchers see as most appropriate.
"When we have to perform resuscitation for the baby in the delivery room, the mother is preoccupied with her own medical condition. Labor and delivery is a stressful time for parents and it's difficult for her to process the information about the procedure that will be performed on her baby," Strand said.
"It is even harder for the parents to weigh the risks and benefits of participating in a study. Through this current research, we want to develop a method of consent for clinical studies in the delivery room that satisfies the ethical requirements of the study but also makes it easier for the parents to understand what questions we are trying to answer through the research."
At any given time, neonatal care units have several ongoing clinical research trials in delivery room settings. Scientists need to enroll newborns who have problems at delivery into studies to determine the best practices to care for babies in the future.
For example, Strand's current research seeks the best way to treat a baby with meconium-stained amniotic fluid - a condition in which a newborn can breathe a combination of fecal matter and amniotic fluid into the lungs at the time of delivery.
"Our standard treatment is to insert a breathing tube into the windpipe and suction whatever meconium might be there. But there are risks to doing this, and we know from other research that active babies don't benefit from this treatment," Strand said. "So, I would like to study that very select group of newborns: non-vigorous infants delivered through meconium-stained fluid."
But Strand's challenge in conducting her study is identifying those infants who would qualify to participate and getting consent from the parent at an emotionally charged time.
"Finding the appropriate time to talk to families about this question is tricky. One option is going to the obstetrician's office and collecting consent from as many mothers as possible who are at 36 weeks pregnant. But probably less than 2 percent of those mothers will deliver babies eligible for the study.
"So, should I introduce the possibility of complicated newborn care, resuscitation issues, possible respiratory failure, meconium aspiration syndrome and other problems that far before delivery? Is that fair to bring this worry to the mothers when they probably won't face this situation?" Strand said.
At this point, Strand says she doesn't know how moms will answer this question. Starting in February, Strand and her team will host eight focus groups, each with six to eight mothers - either pregnant women or women who have delivered within six months prior - and talk about the sticky issue of obtaining medical consent at an emotional time.
Source: Saint Louis University