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A cohort study on bronchopulmonary dysplasia with pulmonary hypertension in premature infants

A cohort study on bronchopulmonary dysplasia with pulmonary hypertension in premature infants

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200056103
Enrollment
Unknown
Registered
2022-02-01
Start date
2022-02-01
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary hypertension associated with bronchopulmonary dysplasia

Interventions

Bronchopulmonary dysplasia/Bronchopulmonary dysplasia-Pulmonary hypertension:N/A

Sponsors

BaYi Children’s Hospital, The Seventh Medical Center of People’s Liberation Army (PLA) General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. The age of admission is less than 3 days; the hospitalization time is >= 28 days and the premature infants who are diagnosed with BPD at 24-32 weeks. 2. Diagnostic criteria and grading of BPD: (1) The time of oxygen inhalation must be above or equal 28 days; (2) Gestational age less than 32 weeks, evaluation should be carried out at 36 weeks corrected gestational age or at discharge, and those with gestational age above 32 weeks should be assessed at 56 days after birth or at the time of discharge, those who do not need oxygen are considered mild; those whose oxygen concentration is less than 0.3 are moderate; those whose oxygen concentration is >= 0.3 or who require positive pressure ventilation are considered severe. 3. According to whether they combined with PH, they were diagnosed into BPD with PH group and BPD without PH group. Diagnostic criteria for PH: 1. Right ventricular systolic pressure (RVSP)>35 mmHg; RVSP=(tricuspid valve flow rate) 2x4+Right atrial pressure (usually 5mmhg); 2. RVSP/systemic systolic pressure ratio>0.5; 3. Any bidirectional or Ventricular septal defect (VSD) or PDA with right-to-left shunt; 4. If there is no tricuspid regurgitation (TR) or shunt, two of the following three criteria: (1) Any degree of flattening of the ventricular septum; (2) Right ventricular dilatation; (3) Right ventricular hypertrophy.

Exclusion criteria

Exclusion criteria: 1. Exclude PH due to congenital heart disease or other anatomical abnormalities (eg, diaphragmatic hernia or thoracic deformity). 2. Children with congenital lung diseases and other congenital heart diseases except PDA, atrial septal defect, ventricular septal defect and patent foramen ovale are excluded. 3. Exclude children who need oxygen or use ventilator due to non-respiratory diseases. 4. Patients are unable to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Echocardiography;Growth and development assessment;Brain natriuretic peptide;

Countries

China

Contacts

Public ContactQiuping Li

BaYi Children’s Hospital, The Seventh Medical Center of People’s Liberation Army (PLA) General Hospital

zhjhospital@163.com+86 15117975597

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026