Neonatal Complex Congenital Heart Disease
Conditions
Interventions
Experimental Group:Surgical operation is performed on neonates aged 7 days (postnatal age).
Sponsors
Central China Fuwai Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
No minimum to 48 Hours
Inclusion criteria
Inclusion criteria: Part One: 1. Neonates diagnosed with TAPVC, CoA/IAA, TGA, PA/IVS, or severe PS via pre-admission cardiac echocardiography; 2. Patients and families demonstrating high compliance, willing to sign informed consent forms and agree to complete one year of follow-up and related examinations. Part Two: 1. Preterm infants (gestational age <36 weeks at birth) and low birth weight infants (<2.5kg) diagnosed postnatally with TAPVC, CoA, TGA, PA/IVS, or severe PS; 2. Neonates requiring emergency surgery due to persistent instability following medical management postnatally.
Exclusion criteria
Exclusion criteria: Part One: 1. Neonatal age > 48 hours (at admission); 2. Preterm infant (gestational age < 36 weeks at birth); 3. Low birth weight (weight < 2.5 kg); 4. Concurrent severe extracardiac anomalies or complex cardiac malformations; 5. Preoperative respiratory or circulatory instability requiring emergency surgery. Part Two: 1. Concurrent severe extracardiac anomalies or complex cardiac malformations; 2. Incomplete clinical documentation; 3. Legal guardian refuses consent for study enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative Mortality and Non-Rehabilitation Discharge Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of surgical age < 7 days due to disease necessity in the control group;Postoperative Intensive Care Unit (ICU) Length of Stay;Postoperative Mechanical Ventilation Time;Postoperative Hospital Length of Stay;Incidence of Adverse Events at 12 Months Postoperatively (All-cause Death, Cardiovascular Death, Residual Structural Lesions, Cardiopulmonary Resuscitation, Heart Failure, and Malignant Arrhythmia); | — |
Countries
China
Contacts
Public ContactTaibing Fan
Central China Fuwai Hospital of Zhengzhou University
Outcome results
None listed