An interventional study of Genetics education at baseline and Hypothetical genomic scenarios at follow-up in Parents of Healthy Newborns, sponsored by Brigham and Women's Hospital. Withdrawn at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-11-12.
Sponsored by Brigham and Women's Hospital · Not applicable and Interventional
A 10 minute baseline survey will be administered to parents of healthy newborn infants while in the hospital after delivery at Brigham and Women's Hospital, to be followed by a 25 minute survey 3-24 months later. We will measure parents' attitudes and preferences related to genome screening of newborns. The specific aims of this study are:
To investigate whether parents' opinions regarding genome screening of newborns change between the first 48 hours post-partum and 3-24 months post-partum.
a. We hypothesize that there will not be significant differences between interest in genome screening results in the 48 hours post-partum compared to 3-24 months post-partum.
To determine whether seeing hypothetical genome screening results affects parents' decisions regarding whether they would want genome screening for their newborn.
Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Baseline survey- demographics only
Genetics education, baseline interest in genome screening - 1
Other: Genetics education at baseline
Baseline survey- demographics only
Other: Hypothetical genomic scenarios at follow-up
Genetics education, baseline interest in genome screening - 2
Other: Genetics education at baseline · Other: Hypothetical genomic scenarios at follow-up
Interest in genome screening for newborn if this service were available through a research study
This is a question created by the investigators. It uses a 5-point Likert scale to measure parents' self-reported interest in genome screening for their newborn.
Time frame: Change between baseline and 3-24 month follow-up
Rate of refusal of newborn screening
Newborn screening refusals are very rare. When they occur, they are tracked by nurses on the postpartum inpatient unit. At the start of all shifts for study recruitment, the research assistant will ask the nurse-in-charge if any patients refused newborn screening since the previous study recruitment shift.
Time frame: baseline
Parental Stress
Parenting Stress Index- short form
Time frame: 3-28 month follow-up
Postpartum bonding
Postpartum Bonding Questionnaire
Time frame: 3-28 month follow-up
This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital