Family Centred Early Intervention of Infants With Congenital Heart Disease

NCT04666857 | Completed

• 1 other identifier: EMI
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators aim to test the feasibility for therapists and acceptability to parents of an early motor intervention for infants with congenital heart disease (CHD) after open heart surgery. This intervention will be compared to the standard care of treatment that is recommended for infants with congenital heart disease at the University Children Hospital Zurich.

Conditions

Congenital Heart Disease in Children

Keywords

congenital heart diseases; open heart surgery; motor development; early intervention; family centred; physiotherapy

Outcome Measures

Primary Outcomes (1)

• Dropout rate

  The primary outcome will test the procedure for its acceptability, estimation the likely rates of recruitment and retention of subjects and the calculation of appropriate sample size. Further objectives are the usefulness of the outcome assessment measures.

  "3 up to 6 months of age" (baseline) and at "12 months of age"

Other Outcomes (11)

• Hammersmith Infant Neurological Examination

  "3 up to 6 months of age" (baseline) and at "12 months of age"

• General Movements

  "3 up to 6 months of age" (baseline)

• Infant Motor Profile

  "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention), at "12 months of age"

Study Arms (2)

standard care

NO INTERVENTION

Control subject will receive standard care of treatment

intervention group

EXPERIMENTAL

intervention group will receive early intervention

Other: early motor intervention

Interventions

early motor intervention OTHER

infants with CHD after open heart surgery will receive early intervention

intervention group

Eligibility Criteria

• Age: 2 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born with severe cyanotic and acyanotic congenital heart disease (e.g. tetralogy of Fallot, pulmonary atresia, transposition of the great arteries, atrial/ventricular septal defects, double outlet right ventricle, ...) who undergo open-heart surgery once before the first 3-6 months of their life
• Parents able to comprehend the patient information linguistically and cognitively
• Informed consent of parents as documented by signature

You may not qualify if:

• Infants with hypoplastic left heart syndrome as they need to undergo several open-heart surgeries within the first period of their life.
• Infants with trisomy 21 and other syndromes like 22q11 microdeletion syndrome, CHARGE syndrome that are often associated with CHD. These infants often show additional cognitive impairments that might confound the effect of our intervention.

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital

Zurich, 8032, Switzerland

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

• Bea Latal, Dr. med.

  University Children's Hospital, Zurich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded to the allocation of participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective monocentric single-blinded, two-arm feasibility randomised controlled interventional pilot trial

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 14, 2020
• Study Start: May 31, 2021
• Primary Completion: December 19, 2022
• Study Completion: February 20, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CH (1)