Genomic Sequencing for Childhood Risk and Newborn Illness

Description

The Genomic Sequencing for Childhood Risk and Newborn Illness (the BabySeq Project) is a research study exploring the use of genomic sequencing in newborns. The National Institutes of Health is funding this study. The investigators will enroll 240 healthy infants and their parents at both the Brigham and Women's Hospital Well Newborn Nursery and the Boston Children's Hospital Neonatal Intensive Care Unit (NICU). A small blood sample will be collected from each infant and genome sequencing may be performed. Six weeks later, results are returned and explained. Over 12 months the investigators are studying the experiences of parents and pediatricians of infants who receive sequencing to help understand how best to use genomics in pediatric care.

Study Start Date

May 2015

Estimated Completion Date

August 2018

Interventions

  • Other: Family history report
  • Genetic: Genomic sequencing

Specialties

  • Pediatrics: Basic Science/Genetics,Neonatology
  • Physician Assistant: Pediatrics

MeSH Terms

  • Disease Susceptibility
  • Genetic
  • Hereditary Disease

Study ID

Brigham and Women's Hospital -- The BabySeq Project

Status

Unknown

Trial ID

NCT02422511

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

1440

Sponsor

Brigham and Women's Hospital

Newborns and Parents at Brigham and Women's Hospital (BWH) Well Newborn Nursery: Inclusion Criteria : 1. Infants born at BWH and admitted to the Well Newborn Nursery 2. At least one biological parent is physically available to have genetic counseling, donate DNA, and provide consent for testing the infant. If the second biological parent is known but not physically present, the second biological parent must be available to have genetic counseling by phone, return a signed consent form by mail, and donate DNA via a mailed saliva kit. If there is a "rearing parent" (an individual who is not biologically related to the infant, but who is dedicated to raising the child), that individual must also provide consent but will not be asked to submit a saliva sample.

Exclusion Criteria

    1. Parents are non-English speaking 2. Parents are unwilling to have genomic reports placed in the medical record or sent to their primary care pediatrician 3. Family has not identified a primary care pediatrician before infant is 30 days old 4. Mother or father younger than 18 years of age 5. Mother or father with impaired decisional capacity 6. Age of infant is older than 30 days 7. One of a multiple gestation 8. Any infant in which clinical considerations preclude drawing 1.0 ml of blood 9. Missing consent of either biological parent (if known) or rearing parent (if applicable) Newborns and Parents in the Boston Children's Hospital (BCH) NICU:

    Inclusion Criteria

      1. Infants admitted to the BCH NICU 2. At least one biological parent is physically available to have genetic counseling, donate DNA, and provide consent for testing the infant. If the second biological parent is known but not physically present, the second biological parent must be available to have genetic counseling by phone, return a signed consent form by mail, and donate DNA via a mailed saliva kit. If there is a "rearing parent" (an individual who is not biologically related to the infant, but who is dedicated to raising the child), that individual must also provide consent but will not be asked to submit a saliva sample.

    Exclusion Criteria

      1. Parents are non-English speaking 2. Parents are unwilling to have genomic reports placed in the medical record or sent to their primary care pediatrician 3. Family has not identified a primary care pediatrician before infant is 30 days old 4. Mother or father younger than 18 years of age 5. Mother or father with impaired decisional capacity 6. Age of infant is older than 30 days 7. One of a multiple gestation 8. Any infant in which clinical considerations preclude drawing 1.0 ml of blood 9. Clinical or molecular diagnosis of aneuploidy 10. Hospital admission expected to be less than 72 hours 11. Admission to the NICU for birth asphyxia related to perinatal issues 12. Premature neonates admitted for typical prematurity-related issues 13. Missing consent of either biological parent (if known) or rearing parent (if applicable)

Gender

Both

Ages

N/A

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Caroline M Weipert MS CGC 617-264-5880 cweipert@genetics.med.harvard.edu
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Meghan Towne MS CGC 617-919-4287 Meghan.Towne@childrens.harvard.edu

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