NCT02676245

Brief Summary

To address the content, timing, efficacy, and impact of prenatal education about newborn screening generally and sample retention specifically.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
664

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

1.1 years

First QC Date

November 17, 2015

Last Update Submit

February 3, 2016

Conditions

Neonatal Screening

Keywords

Prenatal EducationResidual Specimens

Outcome Measures

Primary Outcomes (2)

  • Factual knowledge about newborn screening as assessed through a survey instrument designed for the project

    Knowledge of key items about newborn screening that were conveyed in the educational interventions

    2-4 weeks after due date

  • Factual knowledge about newborn blood spots retention and use as assessed through a survey instrument designed for the project

    Knowledge of key items about newborn dried blood spots that were conveyed in the educational interventions

    2-4 weeks after due date

Secondary Outcomes (6)

  • Knowledge of partners of the pregnant women regarding newborn screening based on a survey instrument designed for the study

    2-4 weeks after due date

  • Knowledge of partners of the pregnant women regarding newborn dried blood spots retention and use based on a survey instrument designed for the study

    2-4 weeks after due date

  • An attitude assessment regarding support for newborn screening programs

    2-4 weeks after due date

  • An attitude assessment regarding support for retention and use of newborn residual dried blood spots

    2-4 weeks after due date

  • The clinical choices made by participants regarding participation in newborn screening

    2-4 weeks after due date

  • +1 more secondary outcomes

Study Arms (3)

Viewing NBS + DBS Educational Movies

EXPERIMENTAL

Group A: pregnant women who will view the NBS and residual specimen movies and printed materials during one visit between 30 and 40 weeks gestation.

Behavioral: Viewing Newborn Screening movieBehavioral: Viewing Residual Dried Blood Spot movie

Viewing NBS Educational Movie only

EXPERIMENTAL

Group B: pregnant women who will view the NBS movie only and printed materials at one visit between 30 and 40 weeks. The movies will be presented on a tablet PC.

Behavioral: Viewing Newborn Screening movie

No Educational Interventions

NO INTERVENTION

Control Group: pregnant women who will receive no experimental intervention during pregnancy or the postpartum period but will receive whatever information is routinely provided by their OB clinic and/or delivery center.

Interventions

Viewing Newborn Screening movieBEHAVIORAL

NBS Movie and printed brochure were viewed by the participants

Viewing NBS + DBS Educational MoviesViewing NBS Educational Movie only
Viewing Residual Dried Blood Spot movieBEHAVIORAL

DBS Movie and and printed brochure were viewed by the participants

Viewing NBS + DBS Educational Movies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (\> 18 years) women
  • Uncomplicated pregnancy
  • English and Spanish speaking
  • Partners of pregnant women who have give birth.

You may not qualify if:

  • Women younger than 18 years
  • Complicated pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Botkin JR, Rothwell E, Anderson RA, Goldenberg A, Kuppermann M, Dolan SM, Rose NC, Stark L. What parents want to know about the storage and use of residual newborn bloodspots. Am J Med Genet A. 2014 Nov;164A(11):2739-44. doi: 10.1002/ajmg.a.36694. Epub 2014 Aug 4.

    PMID: 25131714RESULT

  • Botkin JR, Rothwell E, Anderson RA, Rose NC, Dolan SM, Kuppermann M, Stark LA, Goldenberg A, Wong B. Prenatal Education of Parents About Newborn Screening and Residual Dried Blood Spots: A Randomized Clinical Trial. JAMA Pediatr. 2016 Jun 1;170(6):543-9. doi: 10.1001/jamapediatrics.2015.4850.

    PMID: 27043416DERIVED

Study Officials

  • Jeffrey R Botkin, MD, MPH

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics, Chief Division of Medical Ethics and Humanities, Associate Vice President for Research

Study Record Dates

First Submitted

November 17, 2015

First Posted

February 8, 2016

Study Start

September 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 8, 2016

Record last verified: 2016-02