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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. SCHAMBRA. 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.
QUESTIONS SUBMITTED BY THE SUBCOMMITTEE 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:)
QUESTIONS SUBMITTED BY THE SUBCOMMITTEE
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. In . 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 U.S. 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.
SUDDEN INFANT DEATH SYNDROME (SIDS)
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. The 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 e.ther 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?
Answer. The research that is conducted under these Cooperative Agreements has a high probability of supplying information that will lead to our ability to predict which infants are likely to suffer from breathing dysfunctions that are life-threatening to the infants. The infants will be evaluated extensively in the hospital at entry, and during the course of the study to look for breathing dysfunctions that are not monitored in the home, but we know are more common in infants who die of SIDS. This information will be correlated with episodes of apnea, slowed heart rate, and reduced oxygenation that are recorded in the home, and with their clinical outcome; e.g., do they require resuscitation, or do they recover normal breathing on their own? It is hoped that we will be able to identify characteristics that will distinguish between those infants who are destined for severe breathing dysfunction from those who are not.
INFERTILITY AND REPRODUCTIVE RESEARCH CENTERS
Question. We've all heard a lot about NORPLANT, the most recent breakthrough in contraceptive implant devices. So, I'm interested to know how the Institute's own contraception research, as well as research in the area of infertility, is progressing With funds added by the Senate last year, I understand that you are establishing 2 infertility research centers and 3 contraceptive research centers. What is the status of these centers and what will each of these have as a specific research focus?
Answer. Regarding the infertility research centers, the NICHD has designed and obtained NIH approval for a Cooperative Specialized Research Center Program to be represented by two centers composed of multiple, interactive projects. These Centers will serve as national resources for the conduct of high priority infertility research and also as sites promoting the career development of young scientists selecting careers in infertility research. The national competition for these Centers was announced in a Request for Applications by the NIH on March 8, 1991. Potential applicants are presently being provided with requested items of information. The application deadline is June 17, 1991. Following initial scientific peer review, the applications will receive a secondary review by the National Advisory Child Health and Human Development Council, before funding of the selected Centers in September, 1991. The selected Centers are expected to become operational shortly thereafter. The research of the selected Centers will address topics such as the development of new approaches to the treatment of endometriosis, ovulatory dysfunction, uterine fibroid impairment of fertility status, or male factor-based infertility.
Regarding the contraceptive research centers, a Request for Applications (RFA) was issued on March 8, 1991, describing the research program in broad terms and requesting scientists to focus on specific steps of the research process. This RFA also had a deadline of June 17, 1991 for receipt of applications. From the letters and telephone calls that we have received, we expect a very enthusiastic response from our scientific community. We anticipate receipt of applications that will address fertility regulation in both men and women. While the specifics of these applications are not available to us at the present time, we are confident that they will include research on new drugs, potential vaccines, barrier contraceptives and new approaches to sterilization. The Institute
will work very closely with the scientific community to move the centers program forward.
CHILD HEALTH RESEARCH CENTERS
Question. The Committee is certainly aware that a strong basic scientific research program is critical if we are going to transfer this knowledge to clinical applications in order to help children. Along that line, what is the current status of the Child Health Research Centers?
Answer. The Child Health Research Centers Program is intended to increase the ability of pediatric institutions to develop basic science investigative capacities for application to pediatric clinical problems. Seven centers were established in FY 1990. The FY 1991 Appropriation provides funds to support a total of 11 centers, four of them new in FY 1991. A Request for Applications for the new Centers was published on January 25, with a receipt date of April 9, 1991. It is expected that there will be 40-50 applications received, with the initial review scheduled for June 11-13 and funding before the end of the fiscal year.
INFANT DAY CARE
Question. Doctor Alexander, I'm sure you know the success we had during the last Congress in establishing and funding the new child care program. The Committee is certainly interested in the Institute's work on the effect of various early child care arrangements on an infant's later development. I understand that research is under way at 10 different sites tracking about 1,200 children from birth to age 3 to learn more about the effects on the child's development of different child care arrangements. What are the different child care arrangements that will be studied?
Answer. The NICHD Study of Early Child Care will provide information on the various child care arrangements utilized in the United States in the 1990s and will examine the effects of these child care arrangements on child development through the first three years of life. The study is in the process of recruiting both families with mothers who plan to go to work outside of the home before their child's first birthday and families with mothers who plan to stay at home.
There are numerous child care arrangements, as infants may be cared for by others in their own home or receive care in someone else's home or a child care facility. In some cases, a relative such as a father, grandfather, or an aunt may provide care, but in many instances the provider is unrelated to the child's family. Other variables include the number of hours per week the child is in day care and the quality of the day care program. At times, the same infant is placed in multiple care arrangements each week and many infants are switched from one child care arrangement to another as months go by. The NICHD Study of Early Child Care will collect information about the number, type and quality of the arrangements that the children experience. The study will follow the same children over the first three years of their life.
The study will provide information about child care arrangements and their influence on the development of thinking and