Our baby was dying a half-dozen ways. She was born in the 23rd week of pregnancy weighing 1 pound, 4 ounces. Twiggy and translucent, her body heaved along with the mechanical whooshing of a ventilator that kept her alive while battering her lungs. No matter what the doctors did, she would probably end up dead or broken.
In the 196 days we sat by her bedside at All Children's Hospital, we signed consent forms allowing nurses to shove tubes down her throat and slip IVs into her thready veins. We consented to central lines that carry an overwhelming infection risk. We consented to chest tubes, blood transfusions and an operation so risky the surgeon fully expected it to kill her.
Signing those forms was my first official act as her mother, and the responsibility made my cheeks hot. But I didn't read a single one. The only thing I remember about any of those forms was how it felt to write next to my name that I was her mom.
Now the medical community is engaged in a furious debate about consent forms used in important pediatric research. Major studies conducted on babies like mine have come under attack from the consumer advocacy group Public Citizen, which says the research put babies at risk, and that parents were not adequately warned.
The debate has ensnared dozens of research institutions and just about every notable pediatric bioethicist in a fundamental debate over how to conduct research on the most vulnerable people on the planet. The government issued a scolding, the researchers and their supporters lashed back, and the critics are calling for review and derailment of current and future research.
This summer as I listened to hours of debate in which very smart people evoked Tuskeegee and asked "How many babies must die?" it occurred to me that in all the bluster an essential truth was being lost.
All babies born so young are experiments. The rest is just paperwork.
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At issue is a study performed on 1,300 extremely premature infants at 23 institutions from 2004 to 2009. Called the SUPPORT study, it was funded by the National Institutes of Health and approved by review boards at every participating institution. This was not the study of some radical treatment. Instead, it looked at already common treatments and asked which worked better. The implications are broad, because the Affordable Care Act mandates this sort of approach. Without it, treatment choices are more open to influence by gut, insurance payouts and lobbyists.
Doctors know that babies born with underdeveloped lungs need oxygen support to survive. But too much oxygen can wreck developing retinas and make babies blind. As doctors and nurses turn up the oxygen dial on a ventilator to help a struggling baby, they wonder if they are causing eye damage. As they dial it down and allow the baby to work harder to breathe, they wonder if they are damaging lungs or brains. So how much oxygen is the right amount?
Years of practice led to a consensus that a baby's blood oxygen level should be kept between 85 and 95 percent. Alarms sound if those targets are breached. For 6½ months, I sat by my baby's incubator and listened to those alarms, which became more urgent as my daughter struggled. I still hear them sometimes in my sleep.
When the study was designed, no one knew whether 85 percent was better than 95 percent, or where to find sweet spot in between. So researchers randomly sorted the babies into a low-oxygen group with a target of 85-89 percent or a high-oxygen group with a target of 91-95 percent. In a move that enraged critics, researchers rigged the monitors so doctors and nurses couldn't know which group each baby was in. Everyone thought they were aiming for the middle. If a baby was in the low oxygen group, for example, the oxygen saturation would read several points higher on the monitor. All babies stayed within the range commonly accepted as safe.
Critics say it's bad for babies when their care is determined by research protocol, not the judgment of an individual doctor. They say that babies were undoubtedly harmed and that parents should have been warned on consent forms that babies in the low-oxygen group had a greater risk of dying.
But that argument makes a number of assumptions. The first is that researchers expected more babies in the low oxygen group to die, a claim they vigorously dispute. In fact, they say, clinical practice at the time trended toward lower oxygen, because the best evidence said it improved babies' vision without adverse effects. And all the eligible babies were at high risk of death or disability no matter what.
The second is that babies have a single Marcus Welby-type doctor who is certain of what he or she is doing. In reality, critically sick babies are cared for by a constantly rotating team of doctors, nurses, nurse practitioners, residents and specialists. Some are plain smarter or more experienced than others. Some know the baby better than others. Some treat aggressively and some don't. One doctor is pro-life. One has disabled kids. One was unexpectedly widowed. All of these factors influence how they talk to parents, how they assess quality of life and how they interpret risk.
For months I obsessed over my baby's oxygen saturation. The alarms would sound many times in an hour as our daughter struggled and recovered. She didn't hover inside the targeted range ordered by her physicians. She cascaded wildly. Gunk in a tube or even a loud noise or a song she didn't like on the radio would send her crashing. Sometimes all it took to bring her back was another round of the Hokey Pokey. "Keep singing!" our nurse would say. Other times I watched those numbers drop into the 20s as nurses lunged to revive her. Everyone who entered her room had a different threshold for when to intervene. Sometimes a doctor would turn the oxygen up, and as soon as they were gone, the nurse would turn it back down. All this came rushing back to me as I listened to the researchers talk about the "standard of care" as if it were something tangible and logical.
One day, while our baby was still small, one of our favorite doctors explained why it's so hard to know when to fiddle with the oxygen dial. He quoted off the top of his head from the recently completed SUPPORT study, the same study now under attack. He wondered aloud how many babies might go blind so one could live.
"I think about it every day and make my best guess," Dr. Rajan Wadhawan said. "If you're an exact person and a mathematician, it will drive you crazy."
It comforted me, though, to hear him quote that study. It made me feel like he brought more to it than his best guess. He brought an army.
"I stand on the shoulders of giants who came before me," he said.
I knew that before there were any studies, many babies died and were blinded by doctors making their best guesses. I asked Dr. Raj, as we called him, if he ever wondered if he was doing more harm than good. "Every day," he said.
I asked several more doctors the same question. They all gave the same answer.
• • •
Smart people disagree about whether the SUPPORT study was ethical or safe. It turns out that a few more babies in the low-oxygen group died, and a few more babies in the high-oxygen group developed short-term eye disease. But no matter how you measure it, babies in the study did better than babies not in the study. They had lower rates of blindness, disability and death. As a result of the study, doctors changed the way they treat very premature babies.
Our baby's doctors, while applying their best judgment and their very individual experiences, had broad shoulders to stand on. At other moments in our daughter's care, they had little data to guide them. One doctor made a gutsy call to send our daughter to surgery based on faith and a look on our baby's face. We listened to doctors debate "What's the dose of this drug for a two-pound baby?" and no one was sure, because there was no study to consult. Our baby had to go first.
My daughter is 2 now, entirely healthy, saved from death, disability and blindness by a legion of doctors and nurses at All Children's Hospital to whom I owe a limitless debt. Had I been asked, I probably would have signed her up for a research study. If things had gone well, I might have believed the study had helped. If things had gone poorly, I might have blamed the study and feared I'd been duped. "Informed consent" is a holy grail in pediatric medicine, but I doubt it even exists. Someone would have approached me with another form. If it were a doctor who made eye contact or had a nice smile, I would have signed it.
I would not have read the form, because I did not read any of the forms, because the forms are for lawyers, not for parents. I had not slept in days. I was scared out of my mind. I had the mental capacity of a drunk being chased by bears. What kind of form can protect a parent in a situation like that?
In the time we lived in the NICU, we learned to accept risk. Just to enter that place is to embrace terror and uncertainty. There may be risk to participating in a study, but there is also risk to not participating. I don't believe that ethicists and doctors at two dozen institutions conspired to hurt babies. If they decide to tweak the language in their paperwork, so be it. But second-guessing and finger wagging should not hamstring further studies. At the frontier of human possibility, no form can make medicine a safe or predictable endeavor.
What protects our children most is solid research, and the wisdom drawn from babies who came before.
Kelley Benham can be reached at 727-893-8848 or firstname.lastname@example.org. Read the three-part series about her daughter at www.tampabay.com/neverletgo. Dr. Rajan Wadhawan is now director of neonatology at Florida Hospital for Children in Orlando.