Trial Outcomes & Findings for Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach (NCT NCT05387564)

NCT ID: NCT05387564

Last Updated: 2026-01-07

Results Overview

The number of newborns with newborn screen results visible in the electronic healthcare record and presence of documentation of abnormal newborn screen results. By chart review.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 114 participants
• Primary outcome timeframe: Chart review for retrospective patients was done before intervention roll-out. Chart review for prospective patients was done on a rolling basis at 2 months of age for any newborn patient seen during the 18 week intervention period
• Results posted on: 2026-01-07

Participant Flow

Invitations were sent to the "physician in charge" of 20 pediatric primary care sites within one hospital system in the mid-Atlantic region. Seven (7) sites were interested in participating in the pilot project and randomized to intervention arms. Clinicians and caregivers at each site were then recruited via email. Each group of participants is designated as a separate time period below: Clinicians, Caregivers from the retrospective period, caregivers from the prospective time.

Unit of analysis: Clinic Location

Participant milestones

Measure	"All-in" In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once.	"Add-in" In the "add-in" arm, pediatric primary care physicians will have sequential addition of toolkit components in 6 week increments
Clinician STARTED	16 4	12 3
Clinician COMPLETED	16 4	12 3
Clinician NOT COMPLETED	0 0	0 0
Caregiver Survey From Retrospective Time STARTED	22 4	22 3
Caregiver Survey From Retrospective Time COMPLETED	22 4	22 3
Caregiver Survey From Retrospective Time NOT COMPLETED	0 0	0 0
Caregiver Survey From Intervention Time STARTED	15 4	27 3
Caregiver Survey From Intervention Time COMPLETED	15 4	27 3
Caregiver Survey From Intervention Time NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Physician population only

Baseline characteristics by cohort

Measure	"All-in" n=53 Participants In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once.	"Add-in" n=61 Participants In the "add-in" arm, pediatric primary care physicians will have sequential addition of toolkit components in 6 week increments	Total n=114 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=16 Participants • Physician population only	0 Participants n=12 Participants • Physician population only	0 Participants n=28 Participants • Physician population only
Age, Categorical Between 18 and 65 years	16 Participants n=16 Participants • Physician population only	12 Participants n=12 Participants • Physician population only	28 Participants n=28 Participants • Physician population only
Age, Categorical >=65 years	0 Participants n=16 Participants • Physician population only	0 Participants n=12 Participants • Physician population only	0 Participants n=28 Participants • Physician population only
Sex: Female, Male Physicians · Female	13 Participants n=16 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	8 Participants n=12 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	21 Participants n=28 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Sex: Female, Male Physicians · Male	3 Participants n=16 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	4 Participants n=12 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	7 Participants n=28 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Sex: Female, Male Caregivers who completed surveys · Female	36 Participants n=37 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	49 Participants n=49 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	85 Participants n=86 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Sex: Female, Male Caregivers who completed surveys · Male	1 Participants n=37 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	0 Participants n=49 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	1 Participants n=86 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Physicians · American Indian or Alaska Native	0 Participants n=16 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	0 Participants n=12 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	0 Participants n=28 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Physicians · Asian	2 Participants n=16 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	2 Participants n=12 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	4 Participants n=28 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Physicians · Native Hawaiian or Other Pacific Islander	0 Participants n=16 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	0 Participants n=12 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	0 Participants n=28 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Physicians · Black or African American	0 Participants n=16 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	2 Participants n=12 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	2 Participants n=28 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Physicians · White	13 Participants n=16 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	8 Participants n=12 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	21 Participants n=28 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Physicians · More than one race	0 Participants n=16 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	0 Participants n=12 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	0 Participants n=28 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Physicians · Unknown or Not Reported	1 Participants n=16 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	0 Participants n=12 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	1 Participants n=28 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Caregivers who completed surveys · American Indian or Alaska Native	1 Participants n=37 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	1 Participants n=49 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	2 Participants n=86 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Caregivers who completed surveys · Asian	2 Participants n=37 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	1 Participants n=49 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	3 Participants n=86 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Caregivers who completed surveys · Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	0 Participants n=49 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	0 Participants n=86 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Caregivers who completed surveys · Black or African American	8 Participants n=37 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	27 Participants n=49 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	35 Participants n=86 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Caregivers who completed surveys · White	21 Participants n=37 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	17 Participants n=49 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	38 Participants n=86 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Caregivers who completed surveys · More than one race	2 Participants n=37 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	1 Participants n=49 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	3 Participants n=86 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Race (NIH/OMB) Caregivers who completed surveys · Unknown or Not Reported	3 Participants n=37 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	2 Participants n=49 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.	5 Participants n=86 Participants • Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
Confidence regarding hemoglobinopathies Confidence to interpret the hemoglobinopathy newborn screen results	7.33 units on a scale (1-10, 10 'extremely') STANDARD_DEVIATION 2.2 • n=16 Participants • Based on physicians enrolled (not caregivers)	7.33 units on a scale (1-10, 10 'extremely') STANDARD_DEVIATION 2.0 • n=12 Participants • Based on physicians enrolled (not caregivers)	7.33 units on a scale (1-10, 10 'extremely') STANDARD_DEVIATION 2.1 • n=28 Participants • Based on physicians enrolled (not caregivers)
Confidence regarding hemoglobinopathies Confidence to discuss hemoglobinopathy results with family	8.08 units on a scale (1-10, 10 'extremely') STANDARD_DEVIATION 1.83 • n=16 Participants • Based on physicians enrolled (not caregivers)	7.5 units on a scale (1-10, 10 'extremely') STANDARD_DEVIATION 1.7 • n=12 Participants • Based on physicians enrolled (not caregivers)	7.75 units on a scale (1-10, 10 'extremely') STANDARD_DEVIATION 1.76 • n=28 Participants • Based on physicians enrolled (not caregivers)
Confidence regarding hemoglobinopathies Confidence to discuss inheritance of hemoglobinopathies	7.19 units on a scale (1-10, 10 'extremely') STANDARD_DEVIATION 2.07 • n=16 Participants • Based on physicians enrolled (not caregivers)	8.50 units on a scale (1-10, 10 'extremely') STANDARD_DEVIATION 2.20 • n=12 Participants • Based on physicians enrolled (not caregivers)	7.75 units on a scale (1-10, 10 'extremely') STANDARD_DEVIATION 2.19 • n=28 Participants • Based on physicians enrolled (not caregivers)
Confidence regarding hemoglobinopathies Confidence to discuss reproductive options for hemoglobinopathies	5.8 units on a scale (1-10, 10 'extremely') STANDARD_DEVIATION 2.21 • n=16 Participants • Based on physicians enrolled (not caregivers)	6.25 units on a scale (1-10, 10 'extremely') STANDARD_DEVIATION 2.99 • n=12 Participants • Based on physicians enrolled (not caregivers)	6.00 units on a scale (1-10, 10 'extremely') STANDARD_DEVIATION 2.54 • n=28 Participants • Based on physicians enrolled (not caregivers)

PRIMARY outcome

Timeframe: At conclusion of study: 18 weeks after initial roll-out of interventions

Population: At conclusion of study: 18 weeks after initial roll-out of interventions.

Acceptability of toolkit components by pediatric primary care providers by survey at the end of the study (i.e. 18 weeks after initial roll-out of interventions). Reported as the number who answered Agree or Strongly Agree on a 4-point Likert scale that they liked the toolkit component. Likert scale options included strong disagree, disagree, agree, strongly agree.

Outcome measures

Measure	"All-in" n=13 Participants In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once.	"Add-in" n=10 Participants In the "add-in" arm, pediatric primary care physicians will have sequential addition of toolkit components in 6 week increments
Acceptability Liked the newborn screen EPIC prompt	11 Participants	8 Participants
Acceptability Liked the educational module	11 Participants	8 Participants
Acceptability Liked the reference materials	10 Participants	5 Participants

PRIMARY outcome

Timeframe: At conclusion of study (18 weeks after initial roll-out of interventions)

Population: Based on participants who answered final survey at 18 weeks post intervention

Confidence to document/discuss SCT result by pediatric primary care providers by survey. Scale 1 to 10: 1 = not confident at all, 10 = extremely confident.

Outcome measures

Measure	"All-in" n=16 Participants In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once.	"Add-in" n=12 Participants In the "add-in" arm, pediatric primary care physicians will have sequential addition of toolkit components in 6 week increments
Self-efficacy Confidence to interpret the hemoglobinopathy newborn screen results	8.55 units on a scale (1-10) Standard Deviation 1.37	8.20 units on a scale (1-10) Standard Deviation 1.32
Self-efficacy Confidence to discuss hemoglobinopathy results	8.27 units on a scale (1-10) Standard Deviation 1.35	8.8 units on a scale (1-10) Standard Deviation 0.78
Self-efficacy Confidence to discuss inheritance of hemoglobinopathies	8.73 units on a scale (1-10) Standard Deviation 1.42	8.89 units on a scale (1-10) Standard Deviation 0.92
Self-efficacy Confidence to discuss reproductive options of hemoglobinopathies	6.18 units on a scale (1-10) Standard Deviation 2.48	7.0 units on a scale (1-10) Standard Deviation 2.36

PRIMARY outcome

Timeframe: Survey at end of study: 18 weeks after roll-out of interventions

Number of pediatric primary care providers who used individual toolkit components in the last 6 weeks of the study (week 12-18) as indicated by answering "yes" to questions about whether individual toolkit components were used on a survey at the end of the study (18 weeks after roll-out of interventions).

Outcome measures

Measure	"All-in" n=16 Participants In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once.	"Add-in" n=12 Participants In the "add-in" arm, pediatric primary care physicians will have sequential addition of toolkit components in 6 week increments
Feasibility of Using Toolkit Components Reference Materials	11 Participants	8 Participants
Feasibility of Using Toolkit Components EHR Prompt	13 Participants	10 Participants
Feasibility of Using Toolkit Components Educational video	12 Participants	9 Participants

PRIMARY outcome

Timeframe: Chart review for retrospective patients was done before intervention roll-out. Chart review for prospective patients was done on a rolling basis at 2 months of age for any newborn patient seen during the 18 week intervention period

Population: Number of newborn patients in the all-in and add-in arms who were seen at sites enrolled in the trial during the retrospective and prospective periods. Chart reviews completed on all patients. Chart review for retrospective patients was done before intervention roll-out. Chart review for prospective patients was done at 2 months of age.

The number of newborns with newborn screen results visible in the electronic healthcare record and presence of documentation of abnormal newborn screen results. By chart review.

Outcome measures

Measure	"All-in" n=881 Participants In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once.	"Add-in" n=825 Participants In the "add-in" arm, pediatric primary care physicians will have sequential addition of toolkit components in 6 week increments
Penetration Newborn screen available in EPIC - Retrospective	424 Participants	303 Participants
Penetration Newborn screen available in Careeverywhere - Retrospective	167 Participants	179 Participants
Penetration Sickle cell trait on newborn screen - Retrospective	9 Participants	13 Participants
Penetration Sickle cell trait on problem list - Retrospective	4 Participants	11 Participants
Penetration Sickle cell trait documented as disclosed - Retrospective	4 Participants	2 Participants
Penetration Newborn screen available in EPIC - Prospective	190 Participants	190 Participants
Penetration Newborn screen available in Careeverywhere - Prospective	54 Participants	70 Participants
Penetration Sickle cell trait on newborn screen - Prospective	4 Participants	9 Participants
Penetration Sickle cell trait on problem list - Prospective	3 Participants	9 Participants
Penetration Sickle cell trait documented as disclosed - Prospective	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Survey for retrospective patients was sent before intervention roll-out. Survey for prospective patients were sent on a rolling basis at 2 months of age for any newborn patient seen during the 18 week intervention period.

Population: Surveys completed

Knowledge of newborn screen results by caregivers via survey.

Outcome measures

Measure	"All-in" n=37 Participants In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once.	"Add-in" n=49 Participants In the "add-in" arm, pediatric primary care physicians will have sequential addition of toolkit components in 6 week increments
Knowledge Survey respondents who reported they received newborn screen results - Retrospective	14 Participants	15 Participants
Knowledge Survey respondents who reported they received newborn screen results - Prospective	6 Participants	18 Participants
Knowledge Survey respondents who reported sickle cell trait on their child's newborn screen -Retrospective	0 Participants	2 Participants
Knowledge Survey respondents who reported sickle cell trait on their child's newborn screen -Prospective	0 Participants	1 Participants

Adverse Events

"All-in"

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

"Add-in"

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Corinna Schultz

Nemours Children's Health

Phone: 302-651-5500

Email: corinna.schultz@nemours.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place