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NIH Consensus Development Conference:
Inhaled Nitric Oxide Therapy
for Premature Infants

October 27-29, 2010
Bethesda, Maryland

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Press Telebriefing
Friday, October 29, 2010 - 2:00 pm EDT

OPERATOR: Good day ladies and gentlemen and welcome to the NIH Consensus Development Conference on Inhaled Nitric Oxide Therapy for Premature Infants. At this time, all lines have been placed on a listen-only mode but the floor will be open for questions following the presentation.

If anyone should need assistance throughout the conference, you may reach a live operator by pressing star zero on your telephone keypad. At this time, it is my pleasure to turn the floor over to your host, Elizabeth Neilson, senior advisor with the NIH Consensus Development Program. Ma’am, the floor is yours.

ELIZABETH NEILSON, SENIOR ADVISOR, NIH: Good afternoon and welcome. Thank you very much for joining us today. This conference was presented by OMAR, the Office of Medical Applications of Research and the Eunice Kennedy Shriver National Institute of Child Health and Human Development as part of the NIH Consensus Development Program.

The conference on Inhaled Nitric Oxide Therapy for Premature Infants was held at the National Institutes of Health in Bethesda, Maryland, October 27th through the 29th, 2010. It was co-sponsored by the National Heart, Lung and Blood Institute and supported by other components of the U.S. Department of Health and Human Services.

For those of you who may not be familiar with NIH Consensus Development Program there are a few points that are important to bear in mind. The members of this Consensus Development Panel were selected because they have expertise in relevant fields such as biostatistics, child psychology, clinical trials, epidemiology, ethics, healthcare advocacy, neonatology, nursing, pediatric neurobehavior, neurology, pulmonology, neurologic surgery, pediatrics, perinatology and research methodology.

The panel members are viewed by their peers as highly skilled in critically examining scientific evidence. Biographies of the panel members are available at on the media resources page. The panel members came to this process free of academic or financial bias regarding the conference topic. As conditions for their inclusion on the panel, they must hold no financial interest in an entity that could be benefitted or harmed by the conference findings.

The panel members have spent the last several weeks reviewing published literature and have spent the last two days absorbing testimony from experts in the field and the conference audience. Following the conference presentations and discussions, the panel met until late last night in executive session to weigh the evidence and to prepare their statement answering the six key conference questions.

The panel members performed this task on a volunteer basis. The NIH covers their expenses for traveling to the conference but they are not compensated for their time. It is also important to recognize that the panel issues its statement as an independent group. Their statement does not represent a policy or position statement of the National Institutes of Health or the Federal Government.

The panel’s draft statement has been posted to the media resources page for the inhaled nitric oxide conference available at The panel chair presented this draft to the conference audience at 9:00 this morning followed by a discussion period to allow the audience to offer comments on the draft.

The statement includes a roster of the panel members, many of whom are here today to answer your questions as part of this telebriefing. The panel met in executive session again between 11:00 a.m. and 2:00 p.m. today to discuss the public comments received. The revised draft statement will be posted to the consensus development program web site later today.

Now just a few procedural points before I turn things over to our panel chair, Dr. F. Sessions Cole. Dr. Cole will provide a brief overview of the panel’s findings after which there will be time for questions, which may be answered by Dr. Cole or another member of the panel. The telebriefing will end promptly at 3:00, if not before. Press star one to be placed in queue to ask a question and a moderator will recognize you in turn and un-mute the line so you can speak.

And finally, only members of the media are permitted to ask questions during this telebriefing. Other interested parties are welcome to listen in but will not be recognized to address the panel with questions. And with that, I’ll turn things over to our panel chair Dr. F. Sessions Cole of the Washington University School of Medicine and Saint Louis Children’s Hospital -- Dr. Cole.

F. SESSIONS COLE, M.D.: Thank you very much, Elizabeth. It was a pleasure and an honor for all of us on the panel to have the opportunity to examine the totality of data about an important potential therapy for critically ill newborn infants who are born far too soon, far too vulnerable.

Preterm birth is a major public health problem in the United States. And among the organ systems most vulnerable in premature babies are the lungs and the brain. Therapies that attempt to improve outcomes both short-term and long-term for prematurely born infants must focus on improving outcomes of lungs and brains in these patients.

We examined data from 14 randomized controlled trials performed to examine the effects of inhaled nitric oxide, a ubiquitously produced gas in the human body with multiple regulatory effects, on improving the outcome of lung function and brain intactness in prematurely born infants.

We were fortunate in that the investigators and the trials that we were able to examine reflected extraordinary commitment, a high degree of intellect, and a substantial amount of passion. The diversity of the trials presented some challenges for us as we tried to understand the effects of inhaled nitric oxide on premature infants.

We found that while there has been considerable interest and work on the use of inhaled nitric oxide for infants born prematurely more than six weeks early that at present we do not find sufficient evidence to warrant the routine use of this inhaled gas to improve outcomes for prematurely born newborn infants.

We are anxious that the investigators and relevant funding agencies continue to pursue all strategies including more studies of inhaled nitric oxide in an attempt to address this extraordinarily important patient population. I’d be happy to answer questions now from the audience.

NEILSON: Thank you very much. Dr. Cole, I think we’re ready to take the first question.

OPERATOR: As a reminder ladies and gentlemen if you do have a question please press star one on your telephone keypad at this time.

NEILSON: As we wait to see if there are any questions, I’d like to point out that there will be a playback of this telebriefing available shortly after the call. Just dial 888-632-8973; the replay code is 30780312. This information is also posted on our media resources page.

If you have any questions for me, I can be reached at 301-496-4999 or via e-mail at This information is also posted on the media resources page. I’m not seeing any questions so I believe that will end our telebriefing for today. I want to thank - oh I’ve misspoken - someone has joined the line.

OPERATOR: Yes, we have our first question coming in from Bridget Kuehn from JAMA Medical News, please go ahead.

BRIDGET KUEHN, JAMA MEDICAL NEWS: Thank you for taking my call, I appreciate it. I was just wondering if Dr. Cole could give us a little bit more background is this nitric oxide treatment being used routinely now in preterm infants? And what is the benefits or potential risks of doing so?

SESSIONS COLE: The nitric oxide is being used routinely for infants who are in the late preterm or term category, that is to say born at more than 34 weeks gestation, or six or fewer weeks early, to treat a specific condition called persistent pulmonary hypertension. The success of inhaled nitric oxide in that infant population prompted studies to explore the possibility that the same treatment might be used in premature infants to try to reduce lung inflammation and induce lung growth.

There was considerable experimental evidence that inhaled nitric oxide would have a beneficial effect on prematurely born infant lungs. That background prompted 14 randomized clinical trials, which showed varying degrees of effect. The problem for us was that the effects of inhaled nitric oxide were difficult to tease out because of the diversity of study design, which premature patient populations were studied, and the timing, dose, and duration of giving the inhaled nitric oxide.

I think right now there have been several studies that have suggested benefit of inhaled nitric oxide and these one or two studies have prompted off label use of inhaled nitric oxide for babies born more than six weeks early in some nurseries around the country. I think our conclusion from this panel is that we are cautioning against widespread, routine use of inhaled nitric oxide until further studies are completed.

KUEHN: OK, thank you very much.

NEILSON: Bridget, does that answer your question?

KUEHN: Yes, it did.

NEILSON: Thank you and if someone else would like to ask a question please press star one on your keypad. At this point we have no other questions. I would like to thank our very hard working panel as well the reporters that are on the line and those that will be listening to the replay. We hope you’ll join us for future telebriefings. Thank you very much and have a great afternoon.

OPERATOR: Thank you this does conclude today’s teleconference. A replay of this conference will be available later this afternoon. To access the replay please dial 888-632-8973 or 201-499-0429 when prompted enter replay code 30780312. Please visit us on the web at or e-mail us at We thank you for your participation you may disconnect your lines at this time and have a great day.

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  Elizabeth Neilson, Senior Advisor | 301-496-4999

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