The Role of Transthoracic Echocardiography in Diagnosis of Pulmonary Hypertension of Infants With Bronchopulmonary Dysplasia

NCT05082272 | Completed

• 1 other identifier: 6196
• Study Type: observational
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pulmonary hypertension may develop in premature newborn infants due to impaired lung development. The diagnosis of this disease can actually be made with interventional methods. In this study, we evaluated the importance of echocardiographic examination and blood laboratory tests in diagnosing this disease.

Conditions

Pulmonary Hypertension; Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary dysplasia; Pulmonary hypertension; Echocardiography

Outcome Measures

Primary Outcomes (2)

• Echocardiographic examination

  Echocardiographic examination is effective in diagnosing pulmonary hypertension in preterms with bronchopulmonary dysplasia and is consistent with the clinical findings of the patients.

  1 month

• Serum kallistatin level

  Serum kallistatin level is effective in diagnosing pulmonary hypertension in preterms with bronchopulmonary dysplasia and is consistent with the clinical findings of the patients.

  1 month

Study Arms (3)

Preterm neonates with bronchopulmonary dysplasia with pulmonary hypertension

Preterm neonates who continued need for respiratory support persisting at 36 weeks corrected postmenstrual age and diagnosed with pulmonary hypertension on echocardiographic examination

Preterm neonates with bronchopulmonary dysplasia and without pulmonary hypertension

Preterm neonates who continued need for respiratory support persisting at 36 weeks corrected postmenstrual age and whose echocardiographic examination were normal

Healty preterm neonates

preterm neonates with neither bronchopulmonary dysplasia nor pulmonary hypertension

Eligibility Criteria

• Age: 28 Days - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm newborns followed in the neonatal intensive care unit

You may qualify if:

• Born ≤ 28 postmenstrual weeks
• Respiratory support persisting at 36 weeks corrected postmenstrual age.
• Echocardiographic examination consistent with pulmonary hypertension
• BPD patients without PHT
• Born ≤ 28 postmenstrual weeks
• Respiratory support persisting at 36 weeks corrected postmenstrual age.
• Normal echocardiographic examination
• Healty preterms
• Born ≤ 28 postmenstrual weeks
• Do not need respiratory support persisting at 36 weeks corrected postmenstrual age
• Normal echocardiographic examination

You may not qualify if:

• Congenital heart disease (with the exception of patent ductus arteriosus or patent foramen ovale)
• Structural lung and airway malformations (including tracheobrochomalacia)
• Congenital diaphragmatic hernia
• Chromosome abnormality

Sponsors & Collaborators

• Kayseri City Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biomarkers like kallistatin, NT-ProBNP, gelsolin, homocysteine, cystatin C levels were measured. Serum was taken for Kallistatin, gelsolin and cystatin C Plasma was taken for NT-proBNP and homocysteine

MeSH Terms

Conditions

Hypertension, Pulmonary; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist (pediatric cardiolog)

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 18, 2021
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 18, 2021

Record last verified: 2021-10