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Using a Humanoid Robot to Distract Children With Cancer or Chronic Immune Deficiency Undergoing Painful Procedures

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ClinicalTrials.gov Identifier: NCT04003701
Recruitment Status : Not yet recruiting
First Posted : July 1, 2019
Last Update Posted : July 3, 2019
Sponsor:
Collaborators:
Universitair Ziekenhuis Brussel
University Ghent
Information provided by (Responsible Party):
Emma Rheel, Vrije Universiteit Brussel

Brief Summary:

The aim of this study is to examine the effect of using a humanoid robot during a portal catheter (PAC) puncture in children with cancer and peripheral venous cannulation (PVC) in children with chronic immune deficiency (CID), on the pain and fear memory of child and parent in comparison to usual care. The use of a humanoid robot has proven to be effective on reducing healthy children's pain and distress towards vaccinations. Still, whether these benefits generalize to clinically ill children, such as children with cancer or CID, to pain memories and to the parents needs to be examined.

The current research proposal is the first one to examine the use of a humanoid robot to distract children with cancer or CID who undergo repeated painful procedures and, compared to usual care, its effectiveness in reducing negative pain and fear experience and reducing negative pain and fear memory biases.

Children aged 8-12y with cancer undergoing PAC-punctures weekly or every 2 weeks, or with CID having PVC every 2 to 6 weeks, and their parents will be recruited at the University Hospital Brussels. Baseline assessments include child's anticipated pain, pain-related fear and self-efficacy by child's self-report and parent proxy report, child's attention control, attention bias, pressure hyperalgesia, energy-balance related behavior, child's and parent's catastrophizing about the child's pain, parental behavioral responses to their child's pain and parent's emotions towards the child's painful procedure. Stratified block randomization will be used to assign the children to the control group (usual care) or intervention group (robot distraction). Immediately after the puncture procedure, experienced pain, pain-related fear, self-efficacy and pain catastrophizing (state) will be assessed again by child and parent, as well as emotions of the parent. One week post-procedure the participants will be contacted by telephone for a short interview in order to assess child's and parent's pain and pain-related fear memory, as well as child's and parent's future pain, pain-related fear and self-efficacy expectancies using the same scales as administered before and immediately after the procedure, with in addition a free recall and prompted recall about contextual details about the day of the procedure. Recalled pain and pain-related fear ratings that are higher compared to initial reports are considered indicative of negative memory biases.


Condition or disease Intervention/treatment Phase
Childhood Cancer Behavioral: Usual care Behavioral: Robot-assisted puncture procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Using a Humanoid Robot to Distract Children With Cancer or Chronic Immune Deficiency Undergoing Painful Procedures: a Pilot Randomized Controlled Trial Looking at Alterations of Children's and Parents' Pain and Fear Memories
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: Usual care group (control group)
Within the usual care, no one of the attendees in the room will have specific interaction with the child during this procedure, with the exception of normal/necessary interaction by the nurse and/or parent. Only minimal distraction is allowed. The child will sit down on the treatment table with the legs stretched out in front of him and the puncture-side arm in a 90-90 position next to the head supported by the table (cancer patients) or stretched out and lying down along the body (CID patients), with the nurse at the puncture side and the parent at the other side standing next to him. The researcher is also present in the room, within the child's field of vision. At the end of the procedure, the nurse tells the child that he/she did very well.
Behavioral: Usual care
Control group: minimal distraction

Experimental: Robot-assisted puncture procedure (experimental group)
During the experimental intervention, the child, a nurse, one of the parents/guardians, a researcher and the humanoid robot NAO (H25 Academic Edition, Aldebaran Robotics, Paris, France) will be present in the same room. The child will sit down in the same position as with the usual care. Next to the patient a humanoid robot of three-foot tall will sit on eye level on a slanted reading table, at the non-puncture side. The nurse will carry out the puncture procedure as performed as usual. The robot is programmed to distract the child during the entire procedure (before, during and after the puncture) by playing a game with the child based on his/her interests. The child can therefore choose between a number of games in different themes. In the end the robot tells the child that he/she did very well. During the whole intervention, the robot will be re-activated for each phase only when the child and the nurse are ready.
Behavioral: Robot-assisted puncture procedure
Experimental group: distraction with robot




Primary Outcome Measures :
  1. Pain memory bias (numeric rating scale) (child) [ Time Frame: 1 week post-intervention (calculation method = T3-T1 and T3-T2) ]
    Pain rated by self-report on an 11-point numeric rating scale (NRS-11) reported 1 week post-intervention (T3) minus anticipated pain reported just before intervention (T1), and pain reported 1 week post-intervention (T3) minus experienced pain reported immediately after intervention (T2).

  2. Pain memory bias (faces pain scale - revised) (child) [ Time Frame: 1 week post-intervention (calculation method = T3-T1 and T3-T2) ]
    Pain rated by self-report using the Faces Pain Scale Revised (FPS-R) reported 1 week post-intervention (T3) minus anticipated pain reported just before intervention (T1), and pain reported 1 week post-intervention (T3) minus experienced pain reported immediately after intervention (T2).

  3. Pain-related fear memory bias (numeric rating scale) (child) [ Time Frame: 1 week post-intervention (calculation method = T3-T1 and T3-T2) ]
    Pain-related fear rated by self-report on an 11-point numeric rating scale (NRS-11) reported 1 week post-intervention (T3) minus anticipated pain-related fear reported just before intervention (T1), and pain-related fear reported 1 week post-intervention (T3) minus experienced pain-related fear reported immediately after intervention (T2).

  4. Pain-related fear memory bias (children's fear scale) (child) [ Time Frame: 1 week post-intervention (calculation method = T3-T1 and T3-T2) ]
    Pain-related fear rated by self-report using the Children's Fear Scale (CFS) reported 1 week post-intervention (T3) minus anticipated pain-related fear reported just before intervention (T1), and pain-related fear reported 1 week post-intervention (T3) minus experienced pain-related fear reported immediately after intervention (T2).


Secondary Outcome Measures :
  1. pain intensity (numeric rating scale) (self-report child) [ Time Frame: Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3) ]
    Pain intensity by self-report on an 11-point numeric rating scale (NRS-11) with the anchors of 0 (no pain) and 10 (extremely painful). The higher the score, the higher the pain intensity.

  2. pain intensity (numeric rating scale) (proxy report parent) [ Time Frame: Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3) ]
    Pain intensity of the child on an 11-point numeric rating scale (NRS-11) with the anchors of 0 (no pain) and 10 (extremely painful). The higher the score, the higher the pain intensity.

  3. pain intensity (faces pain scale - revised) (self-report child) [ Time Frame: Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3) ]
    pain intensity by self-report using the Faces Pain Scale-Revised (FPS-R). This revised scale consists of 6 sex-neutral line drawings illustrating an increasing level of pain intensity from the most left face to the most right face.The participant responds by indicating which of the 6 faces corresponds to his or her level of pain. Scores ranges from 0 to 5 (0-1-2-3-4-5), with 5 being the highest possible pain intensity.

  4. pain intensity (faces pain scale - revised) (proxy report parent) [ Time Frame: Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3) ]
    pain intensity of the child using the Faces Pain Scale-Revised (FPS-R). This revised scale consists of 6 sex-neutral line drawings illustrating an increasing level of pain intensity from the most left face to the most right face.The parent responds by indicating which of the 6 faces corresponds to his or her child's level of pain. Scores ranges from 0 to 5 (0-1-2-3-4-5), with 5 being the highest possible pain intensity.

  5. pain-related fear (numeric rating scale) (self-report child) [ Time Frame: Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3) ]
    pain-related fear by self-report on a numeric rating scale (NRS-11) with the anchors of 0 (not scared) and 10 (extremely scared). The higher the score, the higher the pain intensity.

  6. pain-related fear (numeric rating scale) (proxy report parent) [ Time Frame: Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3) ]
    pain-related fear of the child on a numeric rating scale (NRS-11) with the anchors of 0 (not scared) and 10 (extremely scared). The higher the score, the higher the pain intensity.

  7. pain-related fear (children's fear scale) (self-report child) [ Time Frame: Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3) ]
    pain-related fear by self-report using the Children's Fear Scale (CFS). This one-item scale consists of a row of 5 sex-neutral faces varying from a not afraid (neutral) face on the left to a face that shows extreme fear on the right. The participant responds by indicating which of the 5 faces corresponds to his or her level of pain-related fear. Scores range from 0 to 4 (0-1-2-3-4) with 4 being the highest possible fear.

  8. pain-related fear (children's fear scale) (proxy report parent) [ Time Frame: Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3) ]
    pain-related fear of the child using the Children's Fear Scale (CFS). This one-item scale consists of a row of 5 sex-neutral faces varying from a not afraid (neutral) face on the left to a face that shows extreme fear on the right. The parent responds by indicating which of the 5 faces corresponds to his or her child's level of pain-related fear. Scores range from 0 to 4 (0-1-2-3-4) with 4 being the highest possible fear.

  9. self-efficacy (numeric rating scale) (self-report child) [ Time Frame: Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3) ]
    self-efficacy by self-report. All participants will score the same question about how they will deal/dealt with the puncture procedure on a standard 11-point numeric rating scale (NRS-11) from 0 (not good at all) to 10 (extremely good).

  10. self-efficacy (numeric rating scale) (proxy report parent) [ Time Frame: Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3) ]
    self-efficacy of the child. All parents will score the same question about how they think their child will deal/dealt with the puncture procedure on a standard 11-point numeric rating scale (NRS-11) from 0 (not good at all) to 10 (extremely good).

  11. Pain memory bias (numeric rating scale) (parent) [ Time Frame: 1 week post-intervention (calculation method = T3-T1 and T3-T2) ]
    Child pain intensity rated by proxy report by the parent on an 11-point numeric rating scale (NRS-11) reported 1 week post-intervention (T3) minus anticipated pain reported just before intervention (T1), and pain reported 1 week post-intervention (T3) minus experienced pain reported immediately after intervention (T2).

  12. Pain memory bias (faces pain scale - revised) (parent) [ Time Frame: 1 week post-intervention (calculation method = T3-T1 and T3-T2) ]
    Child pain intensity rated by proxy report of the parent on the Faces Pain Scale Revised (FPS-R) reported 1 week post-intervention (T3) minus anticipated pain reported just before intervention (T1), and pain reported 1 week post-intervention (T3) minus experienced pain reported immediately after intervention (T2).

  13. Pain-related fear memory bias (numeric rating scale) (parent) [ Time Frame: 1 week post-intervention (calculation method = T3-T1 and T3-T2) ]
    Child pain-related fear rated by proxy report by the parent on an 11-point numeric rating scale (NRS-11) reported 1 week post-intervention (T3) minus anticipated pain-related fear reported just before intervention (T1), and pain-related fear reported 1 week post-intervention (T3) minus experienced pain-related fear reported immediately after intervention (T2).

  14. Pain-related fear memory bias (children's fear scale) (parent) [ Time Frame: 1 week post-intervention (calculation method = T3-T1 and T3-T2) ]
    Child pain-related fear rated by proxy report by the parent on the Children's Fear Scale (CFS) reported 1 week post-intervention (T3) minus anticipated pain-related fear reported just before intervention (T1), and pain-related fear reported 1 week post-intervention (T3) minus experienced pain-related fear reported immediately after intervention (T2).

  15. Responses to the children's pain experience (parent) [ Time Frame: Day before the intervention (T0) ]
    To measure the responses of the parent to their child's pain episodes, a shortened version of the inventory of parent/caregiver responses to the children's pain experience (IRPEDNA) will be used. The original scale is a self-administered questionnaire with three subscales: (1) solicitousness, (2) discouragement, and (3) promotion of well-behaviors and coping. The shortened version will only include subscale 1 and 3. All 10 items of the shortened version reflect actions and behaviors that the parents may enact after seeing the children's pain behaviors. Participating parents rate each item using a five-point response scale (1, never; 2, hardly ever; 3, sometimes; 4, often; 5, always), with final scores ranging from 10 to 50.

  16. Emotions to children's pain experience (parent) [ Time Frame: Just before intervention (T1) and immediately after intervention (T2) ]
    A series of emotion adjectives is used to assess the emotions of the parents in response to the child's painful procedure. All emotion adjectives will be rated on an 11-point scale ranging from 0 (not at all) to 10 (extremely). Four adjectives will be presented (worried, upset, anxious and sad). The mean score of these 4 adjectives will be calculated, whereby higher scores represent higher levels of parental distress.

  17. Waist circumference (child) [ Time Frame: Just before intervention (T0) ]
    Waist circumference of the child in centimeters, measured at umbilical level and at 4 centimeters above the umbilicus.

  18. Body length (child) [ Time Frame: Just before intervention (T0) ]
    Body length of the child in centimeters.

  19. Body weight (child) [ Time Frame: Just before intervention (T0) ]
    Body weight of the child in kilograms, determined with the TANITA MC-780SMA (from Tanita Corporation).

  20. Body fat percentage (child) [ Time Frame: Just before intervention (T0) ]
    Body fat percentage of the child, determined with the TANITA MC-780SMA (from Tanita Corporation).

  21. Fat mass (child) [ Time Frame: Just before intervention (T0) ]
    Fat mass of the child in kilograms, determined with the TANITA MC-780SMA (from Tanita Corporation).

  22. Fat free mass (child) [ Time Frame: Just before intervention (T0) ]
    Fat free mass of the child in kilograms, determined with the TANITA MC-780SMA (from Tanita Corporation).

  23. Muscle mass (child) [ Time Frame: Just before intervention (T0) ]
    Muscle mass of the child in kilograms, determined with the TANITA MC-780SMA (from Tanita Corporation).

  24. Total body water (child) [ Time Frame: Just before intervention (T0) ]
    Total body water of the child in kilograms, determined with the TANITA MC-780SMA (from Tanita Corporation).

  25. Total body water percentage (child) [ Time Frame: Just before intervention (T0) ]
    Total body water percentage of the child, determined with the TANITA MC-780SMA (from Tanita Corporation).

  26. Intracellular water (child) [ Time Frame: Just before intervention (T0) ]
    Intracellular water (ICW) of the child in kilograms, determined with the TANITA MC-780SMA (from Tanita Corporation).

  27. Extracellular water (child) [ Time Frame: Just before intervention (T0) ]
    Extracellular water (ECW) of the child in kilograms, determined with the TANITA MC-780SMA (from Tanita Corporation).

  28. Body mass index (child) [ Time Frame: Just before intervention (T0) ]
    Body mass index of the child in kilograms/m^2, determined with the TANITA MC-780SMA (from Tanita Corporation).

  29. Visceral fat rating (child) [ Time Frame: Just before intervention (T0) ]
    Visceral fat rating of the child on a scale from 1 to 59, determined with the TANITA MC-780SMA (from Tanita Corporation).

  30. Basal metabolic rate (child) [ Time Frame: Just before intervention (T0) ]
    Basal metabolic rate of the child in kcal, determined with the TANITA MC-780SMA (from Tanita Corporation).

  31. Attention control (child) [ Time Frame: Day before the intervention (T0) ]
    Attention control is defined as an individual's capacity to choose what they pay attention to and what they ignore. Attention control will be assessed using the Attentional Control Scale for Children (ACS-C), which is a 20 item self-rating scale that assesses abilities to focus and shift attention. Ten statements assess the focusing component of attention (''When I concentrate myself, I do not notice what is happening in the room around me'') and the other ten statements assess the shifting of attentional resources (''When I am doing something, I can easily stop and switch to some other task''). A higher score on this scale indicates a better capacity of attentional control.

  32. Attention bias (child) [ Time Frame: Just before intervention (T0) ]
    Attention bias is defined as a selective attention to threat. All participating children will be asked to complete a dot-probe task, which is a well-investigated reaction time task designed to measure selective attention to threat. In this dot-probe task, a threatening (i.e., pain) and neutral stimulus are presented simultaneously (i.e., a painful child face paired with a neutral child face) at two different spatial locations on a screen for a short time. After the appearance of these stimuli, a dot probe emerges at the location of the threatening/pain stimulus (congruent presentation) or at the location of the neutral stimulus (incongruent presentation). The attentional bias is the response time to incongruent trials minus the response time to congruent trials: a positive index indicates more attention to pain; a negative index indicates attentional avoidance.

  33. Pressure hyperalgesia (child) [ Time Frame: Just before intervention (T0) ]
    Pain response to stimuli that are not normally painful, induced by the lowering of the nociceptor threshold level and assessed by evaluating pressure pain thresholds (PPTs) at the dominant tibialis anterior and trapezius muscle by means of a digital pressure algometer (FPX 50, Wagner Instruments, Greenwich, CT, USA). Per test site, 3 measurements are performed with 30 seconds between each measurement. The measurements take place alternately between the two test sites, the first test site being randomly determined by an independent blinded researcher. The pressure pain threshold in kgf per muscle (test site) is determined by the mean of the 2nd and 3rd measurement.

  34. Duration of procedure [ Time Frame: During intervention ]
    Total duration of the puncture procedure, starting at the point at which the door closes after arrival of each person concerned in the room and ending when the puncture procedure is totally finished (everything is fixated on the body with a bandage)

  35. Satisfaction with the robot-interaction [ Time Frame: Immediately after the intervention (T2) ]
    How much did the child like the game with the robot on a scale from 0 (did not like it at all) to 10 (extremely liked it) (NRS-11). Higher scores indicate more satisfaction with the robot-interaction.

  36. Desire for robot-interaction for future procedures [ Time Frame: Immediately after the intervention (T2) ]
    How much the child would like to have the robot with him/her again during a future similar procedure on a scale from 0 (does not want it at all) to 10 (extremely wants it) (NRS-11). Higher scores indicate a higher desire for robot-interaction during future similar procedures.


Other Outcome Measures:
  1. Pain catastrophizing (trait) (child) [ Time Frame: Day before the intervention (T0) ]
    Thoughts and feelings which the child may experience when they are in pain. Children's catastrophic thinking about pain will be assessed with the Dutch version of the Pain Catastrophizing Scale for Children (PCS-C). The scale consists of 13 items describing different thoughts and feelings that children may experience when they are in pain. Children are asked to rate how frequently they experience these thoughts and feelings on a 5-point Likert scale (0 = 'not at all', 4 = 'extremely'). The PCS-C results in a total score (ranging from 0 to 52), and three subscale scores for rumination, magnification and helplessness.

  2. Pain catastrophizing (state) (child) [ Time Frame: Just before the intervention (T1) and immediately after the intervention (T2) ]
    The extent of child state (i.e. situation-specific) catastrophizing thoughts about the procedure will be assessed using an adaptation of the PCS-C. Based on previous research, the investigators use a state version of the PCS-C, consisting of 1 adapted item from each of the 3 subscales. A mean score of these 3 items will be calculated ranging from 0 to 10.

  3. Pain catastrophizing (trait) (parent) [ Time Frame: Day before the intervention (T0) ]
    Thoughts and feelings that parents may experience in relation to their child's pain. Parent's catastrophic thinking about their child's pain will be assessed with the Dutch version of the Pain Catastrophizing Scale for Parents (PCS-P). Similar to the PCS-C, the PCS-P consists of 13 items describing different thoughts and feelings that parents may experience in relation to their child's pain. Parents are asked to rate how frequently they experience these thoughts and feelings on a 5-point Likert scale (0 = 'not at all', 4 = 'extremely'). The PCS-P results in a total score (ranging from 0 to 52), and three subscale scores for rumination, magnification and helplessness.

  4. Pain catastrophizing (state) (parent) [ Time Frame: Just before the intervention (T1) and immediately after the intervention (T2) ]
    The extent of parental state (i.e. situation-specific) catastrophizing thoughts about the puncture procedure will be assessed using an adaptation of the PCS-P. Based on previous research, the investigators use a PCS-P state, consisting of 1 adapted item from each of the 3 subscales. A mean score of these 3 items will be calculated ranging from 0 to 10.

  5. Energy-balance related behavior [ Time Frame: Day before the intervention (T0) ]
    Physical activity and screen behavior. A selection of questions regarding physical activity (E1-E12) and sedentary behavior (F1-F2) of the ENERGY Cross-Sectional Survey (ENERGY CSS child) will be assessed by the participating children.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All participants:

  • Willing to participate and comply with pre-determined interventions
  • 8-12y (children)
  • Child and parent(s)/guardian cohabited for the past 5 years or, in case of divided custody, for at least half of the child's lifetime

Cancer patients:

  • Established cancer diagnosis (any type)
  • First cancer diagnosis
  • Resident port-a-cath
  • Currently being treated for cancer (not necessarily hospitalized) in the University Hospital Brussels

CID patients:

  • Established CID diagnose (any type)
  • Having PVC every 2-6 weeks in the University Hospital Brussels

Exclusion Criteria:

  • Developmental disabilities (e.g.: autism spectrum disorder, Attention Deficit (Hyperactivity) Disorder)
  • Psychiatric disorders (e.g.: anxiety disorder, personality disorder)
  • Significant vision or hearing impairment
  • A primary chronic pain diagnosis (e.g.: fibromyalgia, chronic fatigue syndrome, chronic abdominal pain, migraine, etc.)
  • Not able to read and speak fluent Dutch (parent and child)
  • Already having undergone any kind of self-regulation and/or behavioral therapy for pain (i.e. relaxation, hypnosis, biofeedback, pain neuroscience education, cognitive behavioral therapy, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003701


Contacts
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Contact: Emma Rheel, MSc +32496908353 emma.rheel@vub.be
Contact: Kelly Ickmans, Dr. +32498483347 kelly.ickmans@vub.be

Sponsors and Collaborators
Vrije Universiteit Brussel
Universitair Ziekenhuis Brussel
University Ghent

Publications:
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Responsible Party: Emma Rheel, PhD student, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT04003701     History of Changes
Other Study ID Numbers: ROBOTDISTR_RCT_RE_2019-2020
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emma Rheel, Vrije Universiteit Brussel:
children
cancer
humanoid robot
distraction
pain
pain memory

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases