Parents of Healthy NewbornsBabySeqNCT01736501
Surveying Parents About Genome Screening of Newborns
A study testing Genetics education at baseline and Hypothetical genomic scenarios at follow-up in people with Parents of Healthy Newborns, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parents of Healthy Newborns
- What is being tested?
- Genetics education at baseline and Hypothetical genomic scenarios at follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent of a healthy newborn in the BWH Department of Obstetrics
- English-speaking
Who cannot join
- Impaired decision-making capacity
- Newborn with life-threatening health concerns in the 48 hours post-partum
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
- 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.
- We expect many parents to state initially (in the 48 hours post-partum) that they would elect to have genome screening for their newborn if it were available. In the follow-up survey, half of study participants will receive hypothetical scenarios in which they will need to struggle with the probabilistic and ambiguous nature of the information that could be derived from genome sequencing. We will examine whether this alters their preferences. We will also explore whether parents who receive hypothetical genome screening results scenarios are more likely to alter their preferences than parents who do not receive hypothetical scenarios.
- Conditions
- Parents of Healthy Newborns
- Being tested
- Genetics education at baseline, Hypothetical genomic scenarios at follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetics education at baselineOther
Hypothetical genomic scenarios at follow-upOther
| Study group | Role | What they receive |
|---|---|---|
| Baseline1-demographics | No intervention | Baseline survey- demographics only |
| Baseline1 w/genetics | Other | Genetics education, baseline interest in genome screening - 1 Receives: Other: Genetics education at baseline |
| Baseline2-demographics | Other | Baseline survey- demographics only Receives: Other: Hypothetical genomic scenarios at follow-up |
| Baseline2 w/genetics | Other | Genetics education, baseline interest in genome screening - 2 Receives: Other: Genetics education at baseline; Other: Hypothetical genomic scenarios at follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between baseline and 3-24 month follow-up
Secondary outcomes (1)
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
Why it stopped: This was not a clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parents of Healthy NewbornsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert C. Green, MD, MPH, Brigham and Women's Hospital
- Investigators
- Robert C. Green, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736501
- Sponsor's protocol ID
- 2012-P-001197
- Acronym
- BabySeq
- Status last verified
- Nov 2025
- First submitted
- 1 Nov 2012
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25474344
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveying Parents About Genome Screening of Newborns
- ClinicalTrials.gov ID
- NCT01736501
- Acronym / sponsor ID
- BabySeq / 2012-P-001197
- Conditions
- Parents of Healthy Newborns
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This was not a clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- We expect many parents to state initially (in the 48 hours post-partum) that they would elect to have genome screening for their newborn if it were available. In the follow-up survey, half of study participants will receive hypothetical scenarios in which they will need to struggle with the probabilistic and ambiguous nature of the information that could be derived from genome sequencing. We will examine whether this alters their preferences. We will also explore whether parents who receive hypothetical genome screening results scenarios are more likely to alter their preferences than parents who do not receive hypothetical scenarios.
Study design
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baseline1-demographics | No intervention | –Baseline survey- demographics only |
| Baseline1 w/genetics | Other | Other: Genetics education at baselineGenetics education, baseline interest in genome screening - 1 |
| Baseline2-demographics | Other | Other: Hypothetical genomic scenarios at follow-upBaseline survey- demographics only |
| Baseline2 w/genetics | Other | Other: Genetics education at baseline, Other: Hypothetical genomic scenarios at follow-upGenetics education, baseline interest in genome screening - 2 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parent of a healthy newborn in the BWH Department of Obstetrics
- English-speaking
Key exclusion criteria (2 listed)
- Impaired decision-making capacity
- Newborn with life-threatening health concerns in the 48 hours post-partum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetics education at baseline | Other | Baseline1 w/genetics, Baseline2 w/genetics |
| Hypothetical genomic scenarios at follow-up | Other | Baseline2 w/genetics, Baseline2-demographics |
Primary outcome
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.
1 secondary outcome
Rate of refusal of newborn screening
Time frame: baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Results publication: PubMed 25474344Waisbren 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C. Green, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetics education at baseline and Hypothetical genomic scenarios at follow-up in people with Parents of Healthy Newborns, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01736501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.