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Institute has diligently persisted in attacking and making progress against problems such as infant mortality that are resistant to quick cures; and the Institute has maintained its vitality by embarking upon several new

initiatives such as medical rehabilitation.

Mr. Chairman, the FY 1992 budget request for the National Institute of Child Health and Human Development is $520,584,000. I will be pleased to answer any questions you have.

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Senator HARKIN. Dr. Alexander, thank you very much.

As you know, this is an area of intense interest to me not only because of this subcommittee, but I chair another subcommittee on nutrition and also in the Labor Committee on disability which often occurs in young children because of low birthweight and attendant causes with birth.

I was pleased to learn that the Institute found results of the treatment with gamma globulin on pediatric AIDS so promising. Dr. ALEXANDER. Yes.

Senator HARKIN. And I understand that you got this out early. Dr. ALEXANDER. We did, within 1 week of the time that the data safety and monitoring committee reviewed the data and indicated that the time had come to stop the trial because the results were significant and should be communicated promptly. We had the results out to the public as well as to practicing physicians, including agreement-thanks to the NIH conference that Dr. Raub had helped to put together-with the New England Journal of Medicine that our early release of the information would not jeopardize publication of the results.

Senator HARKIN. I appreciate that. Thank you, and please keep up that good work.

Dr. ALEXANDER. Thank you.

Senator HARKIN. On infant mortality, again I am being asked to shift moneys around for studies.

On infant mortality, as you pointed out in your statement, in black women, the incidence of low birthweight is twice as much as in white women. And you want to set up a study to determine why. Well, isn't it obvious that black women, let's say, lack adequate health care, access to health care? Their nutrition is bad. Their diets are bad. They may have a higher incidence of smoking and alcohol consumption, drug consumption because of their socioeconomic status. It has been my understanding that under the maternal and child health care program through years of study and work in that area that if a woman from month 1 through month 9 has proper nutrition, proper diet, cuts down on alcohol, cuts down on smoking, that the probability of having a low birthweight baby approaches zero.

Dr. ALEXANDER. It does not get quite that good. Even applying what we know, we are not able to reduce low birthweight to that extent. All the statements that you make are correct, and all those factors contribute to a higher incidence of low birthweight, whether in a minority population or in a nonminority population.

If you look at black women versus white women, in the same socioeconomic status, who are college graduates, who are in the optimal childbearing years of age, comparable income, comparable time of prenatal care, diet, whatever else, black women still have twice the incidence of low birthweight as white women. We do not know why that is. We have several studies underway which are trying to get an answer to that.

One is following graduates of minority medical schools over several generations to determine whether higher socioeconomic status

over a longer period of time may tend to reduce the incidence of low birthweight. We know in one generation it does not.

There are other studies that we are doing on socioeconomic differences and ethnic differences in low birthweight that we hope will help to shed some light on these issues.

Senator HARKIN. You talked about the research centers on infertility and contraceptive research centers. That is moving ahead well.

Dr. ALEXANDER. The requests for applications or solicitations are out on those and we expect to fund them in September.

Senator HARKIN. As you know, the Congress funded a new childcare program last year. The first funding actually goes out in September of this year. And, of course, that also falls under my jurisdiction on the Appropriations Committee.

We are interested in your work and your Institute's work on the effect of various early child-care arrangements on later development. I understand that research is underway at 10 different sites tracking about 1,200 children from birth to 3 years of age to learn more effects on the child's development of different child-care arrangements.

How soon will we be able to see some results of this study? Is this something that we are going to have to wait 10 or 15 or 20 years on?

Dr. ALEXANDER. Fortunately, we do not think it will take quite that long. The first infants have been recruited into that study starting in January. It is a study that plans to follow these children until they are age 3. So, hopefully within 4 years, we will have an answer on at least the major indicators of impact, if any, of early infant day care on child development.

Senator HARKIN. Doctor, let me ask Dr. Hoel and Dr. Schambra. If we broke now and came back at 1:30, could you work that in all right?


Dr. HOEL. Yes.

Senator HARKIN. Let me just take a look here. That means that the other panels that are up today would fall back a little bit further, but I would think that we would finish the two of you within about 15 minutes as we have been doing all along. And then we will get to the next two panels after that. Would that be all right? Dr. HOEL. Yes.



Senator HARKIN. There will be some additional questions which will be submitted for your response in the record.

[The following questions were not asked at the hearing, but were submitted to the Institute for response subsequent to the hearing:]



Question. In January, I understand that you released the results of a 31-month multi-center clinical trial that showed treatment with intravenous gamma globulin significantly improved the health of children with AIDS. I was pleased to learn that the Institute found the results of this treatment so promising at such an early point in the study. In fact, I understand the study was terminated a year earlier than expected in order to communicate these findings to the medical and scientific community. What mechanism is in place to allow for such timely release of information?

Answer. The NIH is now in the process of devising such a plan, but currently there is no specific mechanism yet set in place for the dissemination of information for timely release from clinical trials. In the NICHD case, the decision to terminate the trial was made on a Friday and reviewed over the weekend. To disseminate information from the Intravenous Immunoglobulin (IVIG) clinical trial quickly, the NICHD first sent by overnight mail a summary of the trial's findings to each of the members of the NICHD-NIAID pediatric clinical trials network. The overnight mailing went out on Monday afternoon and Tuesday morning. On Wednesday, a mailing was made to the AIDS Advisory Committee of the American Academy of Pediatrics and to the chairs of pediatric departments in medical schools, and a mailing was started to the 30,000+ members of the American Academy of Pediatrics. The NIAID AIDS Clinical Trial Hotline telephone number was publicized, and the information given over the hotline was modified to include the findings from the NICHD clinical trial. A press release was distributed, and a press conference was held on Thursday. Also on Thursday, a summary of the clinical alert was posted on the National Library of Medicine's Medline, a computer message service available to 50,000 physicians. This was the first time Medline was used to help disseminate a clinical alert. A video news release was also put together using background footage and footage shot at the press conference. This video was sent out by satellite on Friday to a potential audience of some two million television viewers.

Question. The Committee has heard that information is often withheld until the material is published in a medical journal. What arrangements were made with the New England Journal of Medicine so that results could be released before publication?


Answer. The NICHD project officer for the IVIG clinical trial contacted the editor of the New England Journal of Medicine within two days of the decision to terminate the clinical trial. discussions with the editor, it was agreed that it was acceptable to disseminate the findings from the trial without endangering, the possibility of publishing the results in the Journal. The editor had two requests: 1) that a manuscript be submitted as soon as possible; and 2) that the clinical alert distributed not be identical to the manuscript submitted for publication. Both of these points were agreeable to the NICHD and a manuscript has been submitted to the Journal.


Question. Doctor, I understand that the infant mortality rate in the US. is 10 per 1,000 for 1988 although the provisional rate for 1989 is 9.7 cases per 1,000 births. While we may see some improvement, the percentage of low birth weight babies has not declined and may even be increasing. What specific intramural research plan has NICHD developed to address low birth weight and infant mortality problems throughout the population?

Answer. In response to this Committee's request contained in the report for the FY 1991 appropriation for the Department of Health and Human Services, the NICHD has developed a proposal for establishment of a new branch in the Institute's Division of Intramural Research encompassing components of clinical research in obstetrics and neonatology, basic laboratory science, epidemiology and applied research in health promotion and public health practice. These activities would be carried out in conjunction with agencies of the District of Columbia, a hospital, and medical schools located in the District. The goal would be a model program of research in pregnancy and perinatology that would address the complex of medical and environmental factors, including "crack" cocaine abuse, that adversely influence pregnancy outcome. The results of the investigations conducted by this branch will be applied to improving infant mortality in the U.S. and solving the many problems that arise from low birth weight.


Question. The Institute's five-year SIDS research and

prevention plan is now entering its third year, and the 1992 budget includes a $2 million increase for the program.

Where does your

research stand with regard to developing and testing an apnea monitoring device?


Answer. The NICHD has published a request for Cooperative Agreement grant applications, RFA HD-91-02, "Event Recordings of High Risk Infants on Apnea Monitors", with a June 1991 application receipt date. Six awards with an anticipated cost of $2,200,000 are planned for September 1991. The purpose of the initiative is to establish a consortium of clinical sites and data center in partnership with NICHD, to conduct a standard common protocol for high risk infants, with central data coordination and analysis. objectives of the protocol are to determine whether home apnea monitors employing event recordings of respiratory, cardiac, and oxygenation parameters are effective in identifying clinically relevant episodes, and to determine the conditions that optimize the use of apnea monitors in these infants. For example, preliminary studies indicate that more than 90 percent of the alarms of infants on apnea monitors are either false alarms, or are of no significance to the health of the baby. By recording the episodes and looking for changes in the oxygenation of the babies, we will determine more efficacious ways to use the monitors. This study will also provide important information on the maturation of respiratory and cardiac control in infants.

Question. Will the research lead to your ability to predict which infants are likely to suffer from these breathing dysfunctions?

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