Parenting After Infant Congenital Heart Defect Diagnosis

NCT01503307 | Completed

• 2 other identifiers: CHW 08/160GC 728
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to learn about parents' experiences following diagnosis of a fetal/neonatal Congenital Heart Defect (CHD). Nurses, physicians, and other health-care clinicians will benefit from an improved understanding of what the diagnosis means to parents and what they expect concerning the infant, being a parent, and caregiving tasks and responsibilities. The investigators expect that the knowledge gained will increase clinicians' ability to respond to parents' needs.

Conditions

Congenital Heart Disease

Keywords

prenatal chd diagnosis; postpartum chd diagnosis; parenting; internal working models

Outcome Measures

Primary Outcomes (1)

• Creation of a typology of perinatal internal working models of parenting in congenital heart disease.

  Qualitative analysis of interviews.

  1 year

Secondary Outcomes (1)

• Parent outcomes

  1 year

Study Arms (1)

Prenatal/Postpartum CHD Diagnosis

parent of a baby (prenatal or postpartum)who was recently found to have a heart defect.

Eligibility Criteria

• Age: Up to 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

In this year-long study, 12 to 16 families (mothers and fathers) will be recruited-6 to 8 of the families from the fetal diagnosis clinic at either Meriter Hospital or Children's Hospital of Wisconsin and 6 to 8 families whose infant is diagnosed soon after birth with a complex CHD at either Meriter Hospital or Children's Hospital of Wisconsin.

You may qualify if:

• at least 18 years old
• English speaking and reading
• not known to have a mental illness or cognitive deficit
• prenatal or postnatal diagnosis of a complex CHD that requires surgical repair or palliation early in the infant's life (i.e., tetralogy of Fallot, atrial-ventricular canal, ventricular septal defect, pulmonary stenosis, tricuspid atresia, hypoplastic right or left heart, or other complex condition). Infants will not be excluded if they also have congenital syndromes or extra-cardiac defects.

You may not qualify if:

• no CHD diagnosis

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Hospital and Health System Foundation, Wisconsin: collaborator
• University of Wisconsin, Madison: collaborator
• University of Minnesota: collaborator

Study Sites (2)

University of Wisconsin Madison

Madison, Wisconsin, 53792, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Karen Pridham, PhD, RN

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Anne C McKechnie, PhD, RN

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2011
• First Posted: January 4, 2012
• Study Start: January 1, 2009
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 25, 2019

Record last verified: 2019-10

Locations

US (2)