Surveying Parents About Genome Screening of Newborns (BabySeq)
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ClinicalTrials.gov Identifier: NCT01736501 |
Recruitment Status
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Active, not recruiting
First Posted
: November 29, 2012
Last Update Posted
: July 12, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | November 1, 2012 | |||
First Posted Date ICMJE | November 29, 2012 | |||
Last Update Posted Date | July 12, 2017 | |||
Study Start Date ICMJE | June 2012 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Interest in genome screening for newborn if this service were available through a research study [ Time Frame: Change between baseline and 3-24 month follow-up ] 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.
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Original Primary Outcome Measures ICMJE |
Interest in genome screening for newborn if this service were available through a research study [ Time Frame: Change between baseline and 3-month follow-up ] 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.
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Change History | Complete list of historical versions of study NCT01736501 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Rate of refusal of newborn screening [ Time Frame: baseline ] 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.
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE |
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Original Other Outcome Measures ICMJE |
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Descriptive Information | ||||
Brief Title ICMJE | Surveying Parents About Genome Screening of Newborns | |||
Official Title ICMJE | Surveying Parents About Genome Screening of Newborns | |||
Brief Summary | 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:
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE | Parents of Healthy Newborns | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Waisbren SE, Bäck 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
1101 | |||
Original Estimated Enrollment ICMJE |
1000 | |||
Estimated Study Completion Date | August 2017 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01736501 | |||
Other Study ID Numbers ICMJE | 2012-P-001197 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Robert C. Green, MD, MPH, Brigham and Women's Hospital | |||
Study Sponsor ICMJE | Brigham and Women's Hospital | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Brigham and Women's Hospital | |||
Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |