Corticosteroid Use in Premature Babies and Lung Ultrasonografi Use in the Progression to Bronchopulmonary Dysplasia

NCT05621785 | Unknown

• 1 other identifier: Kırıkkale University Faculty
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Bronchopulmonary dysplasia (BPD) is one of the most common morbidities in premature infants and is associated with poor neurodevelopmental outcomes . Although mechanical ventilation and oxygen requirements in premature infants have been identified as triggering mechanisms for the development of inflammation and BPD over time, data now support that a number of perinatal events that may stimulate the inflammatory cascade before birth also have important effects. Corticosteroids such as dexamethasone and hydrocortisone have proven to be beneficial for the prevention and management of postpartum BPD due to their anti-inflammatory properties . With this study, the effects of corticosteroid use on lung ultrasound findings in BPD will be investigated, and acute and chronic lung ultrasonography scores will be recorded. A prospective observational study was planned in the neonatal intensive care unit between 2022 and 2024 in premature infants below 32 weeks of gestational age. Demographic data and Lung Ultrasonography findings of these babies will be recorded. Among the patients who are predicted to go to BPD, in the group using corticosteroids, Lung Ultrasonographic imaging will be performed and the effect of corticosteroids on pulmonary findings will be recorded. It is planned to investigate whether postnatal steroid use has an effect on lung ultrasound findings in preterm infants with BPD.

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Outcome Measures

Primary Outcomes (1)

• Bronkopulmoner Displazi under the corticosteroid

  Although the use of corticosteroids in the course of BPD has a positive effect on lung ultrasound findings in the acute period in premature newborn babies, long-term beneficial effects cannot be observed.

  2 years

Interventions

Lung Ultrasonografi DEVICE

All babies under 32 weeks of gestation will be included in the study. All data of postnatal corticosteroid users will be recorded using lung USG

Also known as: corticosteroid

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Gestational age below 32/7 weeks, both sex premature infants

You may qualify if:

• Those who were born in Kırıkkale University Faculty of Medicine Hospital or who were born in other hospitals and were admitted to Kırıkkale University Faculty of Medicine Neonatal Intensive Care Unit within the first 48 hours of life.
• Gestational age below 32/7 weeks
• Those who will be administered postnatal corticosteroids with the decision of the consultant by meeting the diagnostic criteria for going to BPD
• Informed consent was obtained from the family

You may not qualify if:

• Those with cyanotic congenital heart disease
• Those with lung and thorax malformations,
• Those with major congenital anomalies
• Newborns who do not meet the criteria for postnatal corticosteroid therapy or who are not given postnatal corticosteroids by the consultant
• The family's refusal to give informed consent

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kırıkkale University Faculty of Medicine

Kırıkkale, 71000, Turkey (Türkiye)

Location

Related Publications (1)

• Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.

  PMID: 11401896 BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sevde Nur Vural, Asistant Dr

  KIRIKKALE UNİVERSİTY FACULTY OF MEDİCİNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Doctor

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 18, 2022
• Study Start: March 1, 2022
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

TU (1)