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This was not a clinical trial.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline1-demographics | No Intervention | Baseline survey- demographics only | |
| Baseline1 w/genetics | Other | Genetics education, baseline interest in genome screening - 1 |
|
| Baseline2-demographics | Other | Baseline survey- demographics only |
|
| Baseline2 w/genetics | Other | Genetics education, baseline interest in genome screening - 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genetics education at baseline | Other |
| ||
| Hypothetical genomic scenarios at follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change between baseline and 3-24 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Stress | Parenting Stress Index- short form | 3-28 month follow-up |
| Postpartum bonding | Postpartum Bonding Questionnaire | 3-28 month follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert C. Green, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25474344 | Result | Waisbren SE, Back DK, Liu C, Kalia SS, Ringer SA, Holm IA, Green RC. Parents are interested in newborn genomic testing during the early postpartum period. Genet Med. 2015 Jun;17(6):501-4. doi: 10.1038/gim.2014.139. Epub 2014 Dec 4. |
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| Other |
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