POSTGRADUATE OBSTETRICS & GYNECOLOGY. Umbilical Cord Blood Banking

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1 POSTGRADUATE VOLUME 34 NUMBER 15 August 15, 2014 OBSTETRICS & GYNECOLOGY A BIWEEKLY PUBLICATION FOR CONTINUING MEDICAL EDUCATION IN OBSTETRICS AND GYNECOLOGY Umbilical Cord Blood Banking Angela Martin, MD, and Martina Badell, MD Learning Objectives: After participating in this CME activity, the obstetrician/gynecologist should be better able to: 1. Educate patients about potential benefits and uses of banked umbilical cord blood. 2. Describe the difference between public and private umbilical cord banks, including the recommendations of professional committees on the various types of banks. 3. Provide resources to patients about where and how to register for public cord blood banks. 4. Collect and store umbilical cord blood in the delivery room. Umbilical cord blood is rich in stem cells. Transplantation of umbilical cord stem cells has saved the lives of more than 25,000 Americans with leukemia, lymphoma, sickle cell anemia, and several other illnesses in recent years. 1 However, thousands of patients who might benefit from a transplantation die every year waiting for a match. 2 Perhaps stems cells are most well known for their use in bone marrow transplantation. Often, family members of patients seeking bone marrow transplantation are tested in hopes of identifying a match. Approximately 70% of patients will not find a match within their family and will need to seek an unrelated donor. This can be challenging, especially for racial or ethnic minorities, who are much less likely to find an acceptable bone marrow donor in public registries. 1,3 Umbilical cord blood is an alternative source of stem cells for patients seeking an unrelated donor. Advantages of cord blood donation compared with other sources of stem cells include ease of procurement, less stringent requirements for human leukocyte antigen matching, reduced graft-versushost disease, and improved access to transplantation, especially for racial minorities. 3 Dr. Martin is Maternal-Fetal Medicine Fellow, and Dr. Badell is Assistant Professor, Department of Gynecology and Obstetrics, Emory University School of Medicine, 550 Peachtree St NE, Atlanta, GA 30308; mbadell@emory.edu. The authors and all staff in a position to control the content of this CME activity, and their spouses/life partners (if any), have disclosed that they have no financial relationships with, or financial interests in, any commercial organizations pertaining to this educational activity. In addition to saving lives through stem cell transplantation, cord blood is a unique source of pluripotent stem cells that could be used for regenerative medicine. It has been estimated that 1 in 3 people in the United States may benefit from regenerative therapy in their lifetime. 4 Cord blood is being investigated in the treatment of cerebral palsy, traumatic brain injury, autoimmune diseases such as type 1 diabetes and systemic lupus erythematosus, autism, acquired hearing loss, and more expansive use in hematologic disease. 5,6 See Table 1 for a review of current and potential future uses of umbilical cord blood. Umbilical cord blood banking is becoming more common. There was a threefold increase in the number of transplantations using cord blood from 2000 to Every pregnant woman should be provided with a balanced perspective on all cord blood options. Patients will often expect their obstetrician to provide them with the education necessary to make an informed decision on saving, donating, or discarding their umbilical cord blood. Despite the emerging role of cord blood banking, there continues to be a gap between information available to counsel patients and that which is actually provided to them. The purpose of this article is to address this gap by providing comprehensive information on the subject. Public Versus Private Cord Blood Banking With indications for use of umbilical cord blood rapidly expanding, cord blood banks will be competing for donors. Lippincott Continuing Medical Education Institute, Inc., is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Lippincott Continuing Medical Education Institute, Inc., designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits. Physicians should only claim credit commensurate with the extent of their participation in the activity. To earn CME credit, you must read the CME article and complete the quiz and evaluation on the enclosed answer form, answering at least seven of the 10 quiz questions correctly. This activity expires on August 14,

2 Postgraduate Obstetrics & Gynecology August 15, 2014 EDITORS William Schlaff, MD Professor and Chair, Department of Obstetrics and Gynecology, Thomas Jefferson Medical College, Philadelphia, Pennsylvania Lorraine Dugoff, MD Associate Professor and Chief, Division of Reproductive Genetics, Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania FOUNDING EDITORS Edward E. Wallach, MD Roger D. Kempers, MD ASSOCIATE EDITORS Meredith Alston, MD Denver, Colorado Samantha Buery-Joyner, MD Falls Church, Virginia Nancy D. Gaba, MD Washington, DC Jennifer Goedken, MD Atlanta, Georgia Veronica Gomez-Lobo, MD Washington, DC Star Hampton, MD Providence, Rhode Island Enrique Hernandez, MD Philadelphia, Pennsylvania Nancy Hueppchen, MD Baltimore, Maryland Bradley S. Hurst, MD Charlotte, North Carolina Christine Isaacs, MD Richmond, Virginia Peter G. McGovern, MD New York, New York Owen Montgomery, MD Philadelphia, Pennsylvania William D. Petok, PhD Baltimore, Maryland James M. Shwayder, MD, JD Jackson, Mississippi Table 1. Current and Investigative Uses of Umbilical Cord Blood Current Uses Investigative Uses Bone marrow failure syndrome Hemoglobinopathy Leukemia Lymphoma What should a patient be told about cord blood banks? Public banks are accredited nonprofit institutions that receive blood from voluntary anonymous donations and make it available to transplant centers through national registries. This is similar to the process by which the American Red Cross recruits blood donors and distributes products to hospitals and patients in need. There is no cost to the donor, and the primary motivation for donation is to help someone who is in need of a stem cell donor. As of 2010, there were 34 public cord blood banks in the United States collecting donations for cord blood transplantation and/or research. 7 Accredited banks must follow criteria established by international guidelines for the quality of the donated cord blood. 8 Approximately 85% of donated blood units do not meet the eligibility criteria for transplantation, most commonly because of insufficient blood collection, hence too few stem cells. 9 Units that are not suitable for transplantation are usually discarded but may, subject to consent, be used for research or to supply blood products. 10,11 Therefore, even cord blood that does not meet eligibility criteria for transplantation can be of potential benefit to the community. Acquired hearing loss Autism Autoimmune diseases (ie, type 1 diabetes and systemic lupus erythematosus) Cerebral palsy Neurodegenerative diseases (ie, Alzheimer and Parkinson diseases) Regenerative medicine Traumatic brain injury 2 Private cord blood banks store umbilical cord blood for a family to use if the need arises for an autologous or allogeneic transplantation in the future. These samples are not available to the general public. Commonly, private cord blood banks market to expectant parents to provide biological insurance in case a disease develops in the future that can be treated with autologous stem cell transplantation. On the basis of estimates of disease incidence and the probability that the banked stem cells will be an acceptable, compatible donor, the likelihood of these units being used for autologous purposes for an individual family is around 1 in 2500 (0.04%). 12,13 In a survey conducted by the American Society for Blood and Marrow Transplantation (ASBMT), it was reported that of 460,000 privately banked cord blood units, only 99 (0.02%) had been shipped for transplantation. 13 Private cord blood banks levy a charge upon acceptance of the units and an annual storage fee. 1,8 Cost estimates obtained from private umbilical cord banking company websites range from approximately $2000 to almost $5000 for 20 years of storage. In a recent cost-effectiveness analysis, The continuing education activity in Postgraduate Obstetrics & Gynecology is intended for obstetricians, gynecologists, and other health care professionals with an interest in the diagnosis and treatment of obstetric and gynecological conditions. Postgraduate Obstetrics & Gynecology (ISSN ) is published biweekly by Lippincott Williams & Wilkins, Inc., Hunters Green Parkway, Hagerstown, MD Customer Service: Phone (800) , Fax (301) , or customerservice@lww.com. Visit our website at LWW.com. Publisher, Randi Davis. Copyright 2014 Lippincott Williams & Wilkins. Priority Postage paid at Hagerstown, MD, and at additional mailing offices. POSTMASTER: Send address changes to Postgraduate Obstetrics & Gynecology, Subscription Dept., Lippincott Williams & Wilkins, P.O. 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3 August 15, 2014 Postgraduate Obstetrics & Gynecology Table 2. Public Versus Private Cord Blood Banks Public Private Fees None $2000 to $5000 for 20 yrs Placed in national registry Yes No Donor is anonymous Yes No Accessibility Anyone in need of Only the family a transplant paying to store the blood Ability to retrieve blood for No Yes a family member in need at a later date ACOG endorsement Yes No ACOG, American College of Obstetricians and Gynecologists. authors concluded that private cord blood banking is not cost-effective because it costs an additional $1,374,246 per life-year gained on the basis of a 20-year total storage fee of $ See Table 2 for a comparison of public and private cord blood banks. In addition to the financial futility of private cord blood banking, as Herlihy and Delpapa 1 point out in their recent editorial in Obstetrics and Gynecology, there is a broader societal concern with private banking. There is a lost opportunity for patients in need when units cannot be accessed by those in the general public who might benefit, and the group that is most harmed is those ethnic and racial minorities for whom bone marrow donors are limited. 1 Currently, the American College of Obstetricians and Gynecologists (ACOG), 15 the American Academy of Pediatrics (AAP), 16 and the ASBMT 13 do not advocate private cord blood collection and storage unless there is an identified need in the family such that banked cord blood would offer a benefit. For instance, the ASBMT recommends cord blood banking for the use of a family member if a sibling of the expected child has one of the following diseases that can be successfully treated with stem cells: leukemia, lymphoma, hemoglobinopathy, or a bone marrow failure syndrome. 13 There is less literature on the use of umbilical cord blood banking for a parent who has a disease that can be successfully treated with stem cell transplantation. For this indication, the ASBMT recommends banking the cord blood only if the 2 parents of the expected child share human leukocyte antigens. 13 For families in this situation, most public unrelated donor cord blood banks are organized to also support medically indicated cord blood banking from related donors. The National Institutes of Health has funded the Children s Hospital Oakland Sibling Donor Cord Blood Program, which has specific expertise in family banking, especially for children with hemoglobinopathies. It is the largest publicly funded cord blood bank for the purposes of medically indicated family banking and collects cord blood from almost anywhere in the United States as long as the medical indication is appropriate. 13 The list of public banks accepting family storage, often termed as sibling directed donations, is growing (see Practice Pearls). 3 How to Register for Cord Blood Banking Once a patient has made an informed decision to bank her umbilical cord blood, she should be directed to a list of hospitals participating in cord blood collection for public donation. The number of participating hospitals is rapidly expanding and a current list can be found at Support-the-Cause/Donate-cord-blood/How-to-donatecord-blood/Participating-hospitals/. If there is not a participating hospital convenient for the patient, she can register online for a mail-in donation program. The following website provides a link to the public mail-in donation programs and is a valuable resource for expecting parents who might have many other questions: Most public and private programs require the mother to register between 28 and 34 weeks gestation to give the cord blood bank enough time to complete the enrollment process. 17 However, donor registration at the time of admission for labor and delivery facilitates the participation of women who were previously unaware of the opportunity to donate, and this is becoming more widely accepted among public banks. 5 Because of FDA regulations on cord blood, the mother must provide informed consent and pass a health history screening, which includes a maternal venous blood sample, for the safety of potential recipients when collecting blood for public and private banks. Common reasons for which a mother may be excluded from donating include a tattoo or piercing in the past year, a previous cancer diagnosis, and infectious diseases including hepatitis B, hepatitis C, human immunodeficiency virus types 1 and 2, human T-lymphotropic virus types I/II, and syphilis. 17 Collection of Cord Blood at Labor and Delivery Hospitals participating in public cord blood donation should have the necessary information regarding eligibility criteria, informed consent papers, and cord blood collection kits specific for the public blood bank with which they are collaborating. If a woman contacts a public mail-in donation program or has chosen to store cord blood in a private bank, she will receive a kit in the mail to take with her to the hospital. Some mail-in programs require the provider to watch a short training video about cord blood collection procedures. 17 It is beneficial for the patient to remind the hospital staff when she is admitted to labor and delivery that she is planning to collect umbilical cord blood so that the provider and equipment are ready at the time of delivery. 17 After delivery of the infant (vaginally or by cesarean), the umbilical cord should be doubly clamped and cut. The collection process can take place with the placenta in vivo or after placental delivery. It is worth noting that a prolonged delay will allow the blood in the cord to clot, and the opportunity to collect enough volume for donation will be lost. This becomes problematic in light of recent evidence that delayed cord clamping may decrease the risk of anemia in the neonate, with preterm neonates receiving the most benefit. 18,19 Therefore, ACOG recommends not altering the timing of umbilical cord clamping for the purpose of umbilical cord blood banking in preterm babies. 20 In

4 Postgraduate Obstetrics & Gynecology August 15, 2014 addition, some experts suggest that if clamping is delayed, it should not be for more than 2 minutes. 17 The cord between the clamp and the placenta that will be the needle insertion site is cleaned with an antiseptic that is provided in most cord blood collection kits. There will be a clamp on the tubing between the needle and the collection bag that should be closed at this time. The needle attached to the tubing and the collection bag should then be placed into an umbilical vein. The clamp previously closed to occlude the tubing needs to be opened to allow blood to flow into the collection bag. The collection bag should be lowered to allow gravity to aid in collecting as much umbilical cord blood as possible in 3 to 5 minutes. It is important to allow for as much cord blood as feasible to flow into the collection bag. One of the most common reasons donated cord blood is deemed unusable for transplantation is inadequate volume and therefore insufficient stem cell dose. 21 If blood stops flowing from the umbilical cord, it is acceptable to milk the umbilical cord or move the needle to a more proximal part of the umbilical cord, but always remember to sterilize the area of collection before needle insertion. In studies analyzing cord blood volume, the average volume reported ranges from approximately 75 to 125 ml Factors affecting cord blood volume include placental weight, fetal weight, and therefore gestational age. 23,24 Patients should be aware that it might be difficult to collect enough volume from a preterm umbilical cord, and as previously discussed, timing of umbilical cord clamping should not be altered for the purpose of collecting umbilical cord blood for banking for preterm babies. 20 Therefore, women delivering preterm should be made aware of these limitations to make an educated decision on whether to participate. When the collection is complete, close the clamp on the tubing while the needle is still in the vein, and then remove the needle from the cord. Several companies also recommend tying knots in the tubing to prevent any spillage of cord blood during transport. Remember to fill out the label on the collection bag, which should be included in both public and private cord blood banking kits. Cord blood collections should be kept at room temperature. 25,26 Finally, remember to send a maternal venous blood sample with the collected cord blood to allow for testing for diseases that would render the cord blood ineligible for donation. The materials for this maternal blood draw and instructions for the provider should be included in collection kits. The process of collection typically takes 5 minutes or less, but each collection kit may vary slightly and provider instructions should be read before collection. ViaCord and Cord Blood Registry, 2 private cord blood banks, have posted helpful YouTube videos that walk you through the collection of cord blood. 25,26 Conclusion Umbilical cord blood stem cells can be used for a variety of purposes, most commonly for transplantation and treatment of leukemia, lymphoma, a hemoglobinopathy, or a bone marrow failure syndrome. Donations to public banks are free and accessible to anyone in need of stem cell transplantation. Private banks cost from $2000 to $5000 for 20 years of storage and can only be used by the family in the rare event that a family member develops a disease that can be treated with an autologous or allogeneic transplantation. Currently, ACOG, the AAP, and the ASBMT do not advocate private cord blood collection and storage unless there is an identified need in the family such that banked cord blood would offer a benefit. If a patient chooses to donate or store umbilical cord blood, the collection process in the delivery room can be relatively quick and easy, as long as the provider is made aware ahead of time and takes the time to review the kit instructions beforehand. Practice Pearls Most common uses: transplantation and treatment of leukemia, lymphoma, a hemoglobinopathy, or a bone marrow failure syndrome. Public banks: free and accessible to anyone in need of a stem cell transplantation. Private banks: usually $2000; store cord blood exclusively for use by the baby s family. Professional societies: American College of Obstetricians and Gynecologists, American Academy of Pediatrics, American Society for Blood and Marrow Transplantation do not advocate private cord blood collection and storage unless there is an identified need in the family such that banked cord blood would offer a benefit. Cord blood banking for the use of a sibling: storing is recommended if the sibling of the expected child has a disease known to be successfully treated with stem cells. In the delivery or operating room: takes about 5 minutes after the cord is cut with placenta in vivo or after placental delivery Resources for patients: REFERENCES 1. Herlihy M, Delpapa H. Obstetricians and their role in cord blood banking promoting a public model. Obstet Gynecol. 2013;121: National Research Council. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press; General Accounting Office: National Cord Blood Inventory. Practices for Increasing Availability for Transplants and Related Challenges. Washington. DC: General Accounting Office; Harris DT, Rogers I. Umbilical cord blood: a unique source of pluripotent stem cells for regenerative medicine. Curr Stem Cell Res Ther. 2007;2: National Institutes of Health. Bethesda, MD. Clinicaltrials.gov. 6. Zarrabi M, Mousavi SH, Abroun S, et al. Potential uses for cord blood mesenchymal stem cells. Cell J. 2014;15: Broder S, Ponsaran R, Goldenberg A. US public cord blood banking practices: recruitment, donation, and the timing of consent. Transfusion. 2013;53:

5 August 15, 2014 Postgraduate Obstetrics & Gynecology 8. Carlo P. Ethical issues in umbilical cord blood banking: a comparative analysis of documents from national and international institutions. Transfusion. 2013;53: Sun J, Allison J, McLaughlin C, et al. Differences in quality between privately and publicly banked umbilical cord blood units: a pilot study of autologous cord blood infusion in children with acquired neurologic disorders. Transfusion. 2010;50: Bordet S, Minh NT, Knoppers B, et al. Use of umbilical cord blood for stem cell research. J Obstet Gynaecol Can. 2010;32: Parazzi V, Lazzari L, Rebulla P. Platelet gel from cord blood: a novel tool for tissue engineering. Platelets 2010;21: Annas GJ. Waste and longing. The legal status of placental-blood banking. N Engl J Med. 1999;340: Ballen K, Barker J, Stewart S, et al. ASBMT Committee Report. Collection and Preservation of cord blood for personal use. Biol Blood Marrow Transplant. 2008;14: Kaimal A, Smith C, Laros R, et al. Cost-effectiveness of private umbilical cord blood banking. Obstet Gynecol. 2009;114: Umbilical cord blood banking. ACOG Committee Opinion No Obstet Gynecol. 2008;111: Lubin BH, Shearer WT. American Academy of Pediatrics Section on Hematology/Oncology; American Academy of Pediatrics Section on Allergy/Immunology. Cord blood banking for potential future transplantation. Pediatrics. 2007;119: Parent s Guide to Cord Blood Foundation. How to donate cord blood, Accessed January 27, Timing of umbilical cord clamping after birth. Committee Opinion No American College of Obstetricians and Gynecologists. Obstet Gynecol. 2012;120: Kaempf JW, Tomlinson MW, Kaempf AJ, et al. Delayed umbilical cord clamping in premature neonates. Obstet Gynecol. 2012;120(2 Pt 1): Umbilical cord blood banking. ACOG Committee Opinion No American College of Obstetricians and Gynecologists. Obstet Gynecol. 2008;111: Ballen K. New trends in umbilical cord blood transplantation. Blood. 2005; 105: Aufderhaar U, Holzgreve W, Danzer E, et al. The impact of intrapartum factors on umbilical cord blood stem cell banking. J Perinat Med. 31: Yamada T, Okamoto Y, Kasamatsu H, et al. Factors affecting the volume of umbilical cord blood collections. Acta Obstet Gynecol Scand. 2000;79: Mancinelli F, Tamburini A, Spagnoli A, et al. Optimizing umbilical cord blood collection: impact of obstetric factors versus quality of cord blood units. Transplant Proc. 2006;38: Cord Blood Registry. Innovative Collection Kit for Umbilical Cord Blood Banking. Online video clip. YouTube, July 6, Web, January 24, ViaCordVideos. Cord Blood Collection: What Is the Process? Online video clip. YouTube, August 13, Web, January 24, CME Quiz: Volume 34, Number 15 To earn CME credit, you must read the CME article and complete the quiz and evaluation on the enclosed answer form, answering at least seven of the 10 quiz questions correctly. Select the best answer and use a blue or black pen to completely fill in the corresponding box on the enclosed answer form. Please indicate any name and address changes directly on the answer form. If your name and address do not appear on the answer form, please print that information in the blank space at the top left of the page. Make a photocopy of the completed answer form for your own files and mail the original answer form in the enclosed postage-paid business reply envelope. Your answer form must be received by Lippincott CME Institute by August 14, Only two entries will be considered for credit. At the end of each quarter, all CME participants will receive individual issue certificates for their CME participation in that quarter. Participants will receive CME certificates quarterly in April, July, October, and the fourth quarter in January of the following year. For more information, call (800) Online quiz instructions: To take the quiz online, log on to your account at and click on the CME tab at the top of the page. Then click on Access the CME activity for this newsletter, which will take you to the log-in page for CME.lwwnewsletters.com. Enter your username and password for this screen as follows: Your CME username will be the letters LWW (case sensitive) followed by the 12-digit account number above your name on the paper answer form mailed with your issue. Your CME password will be 1234; this password may not be changed. Follow the instructions on the site. You may print your official certificate immediately. Please note: Lippincott CME Institute, Inc., will not mail certificates to online participants. Online quizzes expire at 11:59 pm Pacific Standard Time on the due date. 1. Your patient is 30 weeks pregnant and states she is planning to bank her baby s umbilical cord blood in a private bank because her father has Parkinson disease, and she is hopeful the stem cells will be used to cure him. Which one of the following describes an appropriate response to this request? A. There are some private banks that will store blood for family members of a person with Parkinson disease, which is known to be treated successfully with stem cell transplantation. B. Although treatment of Parkinson disease with stem cells is being investigated, the effectiveness of this treatment is not established. C. You should donate umbilical cord blood to a private bank and then retrieve the blood when your family needs it, as this would be less expensive than donating to a public bank. D. None of the above 5 2. Which of the following statements regarding public cord blood banks is/are true? A. Specimens in public cord blood banks are used more commonly than those in private banks. B. The public banks are free and accessible to anyone in need of a stem cell transplantation. C. Ethnic and racially diverse people in the United States are more likely to find a stem cell match using public cord blood registries. D. All the above 3. Which one of the following statements describes the most common reason that a cord blood bank cannot use the collected cord blood for transplantation? A. The delivery provider forgot to label the sample. B. The mother refused to consent to release the blood for transplantation. C. The sample was contaminated. D. There was not enough blood collected and therefore not enough stem cells.

6 Postgraduate Obstetrics & Gynecology August 15, Which of the following statements regarding cord blood banking is/are true? A. The likelihood that privately banked stem cells will be used for autologous purposes for an individual family is approximately 1 in 2500 or 0.04%. B. Transplantation of umbilical cord stem cells has saved the lives of more than 25,000 Americans. C. A donation to a public cord blood bank is free of charge. D. All of the above 5. Which of the following professional societies advocates for routine private cord blood storage? A. American College of Obstetricians and Gynecologists B. American Academy of Pediatrics C. American Society for Blood and Marrow Transplantation D. None of the above 6. Which of the following conditions is/are appropriate for cord blood banking, if the sibling of an expected child is affected? A. Lymphoma B. Hemoglobinopathy C. Leukemia D. All the above 7. Your patient is interested in donating her baby s umbilical cord blood to a public bank. However, the hospital at which she is planning to deliver does not participate in public cord blood donation. Which one of the following statements describes appropriate advice to this patient? A. Go online and register for a public bank that accepts mail-in donations. B. You should donate umbilical cord blood to a private bank instead. C. You cannot donate umbilical cord blood to a public bank because providers will not know how to collect the umbilical cord blood properly. D. None of the above 8. All of the following are exclusion criteria for umbilical cord donation to public and private cord blood banks except A. hepatitis C B. history of breast cancer C. previous cesarean section D. getting a tattoo within the past year 9. Which one of the following describes appropriate collection of umbilical cord blood? A. Only before placental separation B. At multiple cord sites if necessary C. Only after vaginal delivery D. Only to be attempted in term infants 10. Your patient is admitted for preterm delivery and is likely to deliver a 30-week infant. She asks you about her plan to collect and donate umbilical cord blood. Which one of the following statements provides appropriate advice to this patient? A. Collecting and banking should not be a problem. B. Public banks discard the blood if it is not from a full-term infant. C. The infant may benefit from delayed cord clamping, and this could make cord collection impossible. D. Despite the small infant and placental weight, the volume collected should be sufficient. 6