CompletedNot Applicable

Genomic Sequencing for Childhood Risk and Newborn Illness

United States1,205 participantsStarted 2015-05

Plain-language summary

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 from the Brigham and Women's Hospital (BWH) Well Newborn Nursery and 240 sick infants and their parents at Boston Children's Hospital (BCH) or the BWH 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Infants born at BWH and admitted to the Well Newborn Nursery
✓. 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.
✓. Mother (either rearing or biological) carried the pregnancy

Exclusion criteria

✕. Parents are non-English speaking
✕. Parents are unwilling to have genomic reports placed in the medical record or sent to their primary care pediatrician
✕. Mother or father younger than 18 years of age
✕. Mother or father with impaired decisional capacity
✕. Age of infant is older than 30 days
✕. One of a multiple gestation

What they're measuring

Downstream Health Care Costs Attributable to BabySeq Project Disclosure: Days of Inpatient Care

Timeframe: From disclosure through 10 Months post-disclosure (approx. 15 months after baseline).

Parents' Distress

Timeframe: From baseline through 10 post-disclosure, with time points varying by measure. (Post-disclosure approx. 5 months after baseline; 3-months approx. 8 months after baseline; 10-months approx. 15 months after baseline)

Parent-Child Relationship

Parents' Relationship

Timeframe: From baseline through 10 post-disclosure, with time points varying by measure. Post-disclosure approx. 5 months after baseline; 3-months approx. 8 months after baseline; 10-months approx. 15 months after baseline.

Downstream Health Care Utilization Attributable to BabySeq Project Disclosure: Number of Health Care Provider Visits

Timeframe: From disclosure through 10 Months post-disclosure (approx. 15 months after baseline)

Downstream Health Care Utilization Attributable to BabySeq Project Disclosure: Number of Current Medications at 10 Months

Timeframe: From disclosure through 10 Months post-disclosure (approx. 15 months after baseline)

Trial details

NCT IDNCT02422511

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04

Results submitted2021-04-13

View on ClinicalTrials.gov More Hereditary Disease trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Infants born at BWH and admitted to the Well Newborn Nursery
✓. 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.
✓. Mother (either rearing or biological) carried the pregnancy

Exclusion criteria

✕. Parents are non-English speaking
✕. Parents are unwilling to have genomic reports placed in the medical record or sent to their primary care pediatrician
✕. Mother or father younger than 18 years of age
✕. Mother or father with impaired decisional capacity
✕. Age of infant is older than 30 days
✕. One of a multiple gestation

What they're measuring

Downstream Health Care Costs Attributable to BabySeq Project Disclosure: Days of Inpatient Care

Timeframe: From disclosure through 10 Months post-disclosure (approx. 15 months after baseline).

Parents' Distress

Parent-Child Relationship

Parents' Relationship

Downstream Health Care Utilization Attributable to BabySeq Project Disclosure: Number of Health Care Provider Visits

Timeframe: From disclosure through 10 Months post-disclosure (approx. 15 months after baseline)

Downstream Health Care Utilization Attributable to BabySeq Project Disclosure: Number of Current Medications at 10 Months

Timeframe: From disclosure through 10 Months post-disclosure (approx. 15 months after baseline)