NCT05891405

Brief Summary

Cardiac surgery in babies less than 6 kg of weight is a complex and high-risk procedure. Despite advances in medical technology, mortality and morbidity rates remain high. This study seeks to identify risk factors associated with mortality and morbidity in this population

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Status
unknown

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

First Submitted

Initial submission to the registry

May 28, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

May 28, 2023

Last Update Submit

May 28, 2023

Conditions

Cardiac Surgery in Neonates

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Death after surgery

    1 month postoperative

Secondary Outcomes (1)

  • Morbidity

    1 month postoperative

Interventions

Cardiac surgeryPROCEDURE

Operations for congenital heart diseases

Eligibility Criteria

Age1 Day - 2 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Neonates with congenital heart diseases undergoing surgery for complete or partial treatment with body weight less than 5 kg at time of surgery

You may qualify if:

  • neonates undergoing surgery for congenital heart diseases

You may not qualify if:

  • larger body weights than 5 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cardiac Surgical Procedures

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

May 28, 2023

First Posted

June 6, 2023

Study Start

July 1, 2023

Primary Completion

July 1, 2024

Study Completion

December 1, 2024

Last Updated

June 6, 2023

Record last verified: 2023-05