Bronchopulmonary DysplasiaNCT05621785
Corticosteroid Use in Premature Babies and Lung Ultrasonografi Use in the Progression to Bronchopulmonary Dysplasia
An observational study of Bronchopulmonary Dysplasia and Premature Birth, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Bronchopulmonary Dysplasia, Premature Birth
- What is being tested?
- Lung Ultrasonografi
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 Mar 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- Child, Adult, Older adult
Study population: Gestational age below 32/7 weeks, both sex premature infants
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University Faculty of Medicine
Kirikkale, 71000
About this study
Official title: The Effect of Postnatal Corticosteroid Use on Lung Ultrasonography Scores in Preventing the Development of Bronchopulmonary Dysplasia in Premature Infants
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.
Read the detailed description
It is aimed to show the changes in lung ultrasound findings before, during and after steroid use in premature newborn babies born under 32/7 weeks. Thus, detailed new information will be obtained about the role and importance of corticosteroids in preventing the progression to BPD.
Postnatal corticosteroids are not routinely used to prevent BPD in our unit in our hospital. However, if premature babies meet the following criteria, postnatal low-dose corticosteroids are administered.
In the postnatal third week;
- Premature infants who are still not weaned from invasive mechanical ventilation.
- Those who continue to need non-invasive positive pressure ventilation
- Those who need more than 50% oxygen
Applied steroid protocols:
Dexomethasone:
Total cumulative dose 0.89 mg/kg
- 0.075 mg/kg/dose PO/IV (every 12 hours) for 3 days
- 0.05 mg/kg/dose PO/IV (every 12 hours) 3 days
- 0.025 mg/kg/dose PO/IV (every 12 hours) 2 days
- 0.01 mg/kg/dose PO/IV (every 12 hours) 2 days
Hydrocortisone:
- 1 mg/kg/dose IV/PO (every 12 hours) 7 days
- 0.5 mg/kg/dose IV/PO (every 12 hours) 3 days
Dexsometasone treatment is given in accordance with the DART protocol in infants who cannot wean from invasive mechanical ventilation in accordance with the protocols in use in our unit, which corticosteroid will be used. . In clinical follow-up, corticosteroid preference can be changed by the consultant neonatal specialist according to the general clinical condition of the patient and the accompanying spectrum. Which corticosteroid will be preferred in this observational study will not be known by the team that will conduct the study and will be recorded later.
If more than one corticosteroid use is required in the follow-up, pulmonary ultrasonography findings during the first corticosteroid use will be recorded.
- Conditions
- Bronchopulmonary Dysplasia, Premature Birth
- Being tested
- Lung Ultrasonografi
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasonografiDevice
Also called corticosteroid
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Mar 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevde Nur Vural, Kırıkkale University
- Investigators
- Sevde Nur Vural, Asistant Dr, Principal investigator, KIRIKKALE UNİVERSİTY FACULTY OF MEDİCİNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621785
- Sponsor's protocol ID
- Kırıkkale University Faculty
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
Publications
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.
PubMed 11401896
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postnatal Corticosteroid Use on Lung Ultrasonography Scores in Preventing the Development of Bronchopulmonary Dysplasia in Premature Infants
- ClinicalTrials.gov ID
- NCT05621785
- Acronym / sponsor ID
- Kırıkkale University Faculty
- Conditions
- Bronchopulmonary Dysplasia, Premature Birth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is aimed to show the changes in lung ultrasound findings before, during and after steroid use in premature newborn babies born under 32/7 weeks. Thus, detailed new information will be obtained about the role and importance of corticosteroids in preventing the progression to BPD.
Postnatal corticosteroids are not routinely used to prevent BPD in our unit in our hospital. However, if premature babies meet the following criteria, postnatal low-dose corticosteroids are administered.
In the postnatal third week;
- Premature infants who are still not weaned from invasive mechanical ventilation.
- Those who continue to need non-invasive positive pressure ventilation
- Those who need more than 50% oxygen
Applied steroid protocols:
Dexomethasone:
Total cumulative dose 0.89 mg/kg
- 0.075 mg/kg/dose PO/IV (every 12 hours) for 3 days
- 0.05 mg/kg/dose PO/IV (every 12 hours) 3 days
- 0.025 mg/kg/dose PO/IV (every 12 hours) 2 days
- 0.01 mg/kg/dose PO/IV (every 12 hours) 2 days
Hydrocortisone:
- 1 mg/kg/dose IV/PO (every 12 hours) 7 days
- 0.5 mg/kg/dose IV/PO (every 12 hours) 3 days
Dexsometasone treatment is given in accordance with the DART protocol in infants who cannot wean from invasive mechanical ventilation in accordance with the protocols in use in our unit, which corticosteroid will be used. . In clinical follow-up, corticosteroid preference can be changed by the consultant neonatal specialist according to the general clinical condition of the patient and the accompanying spectrum. Which corticosteroid will be preferred in this observational study will not be known by the team that will conduct the study and will be recorded later.
If more than one corticosteroid use is required in the follow-up, pulmonary ultrasonography findings during the first corticosteroid use will be recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Gestational age below 32/7 weeks, both sex premature infants
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung UltrasonografiAlso: corticosteroidAll babies under 32 weeks of gestation will be included in the study. All data of postnatal corticosteroid users will be recorded using lung USG | Device | – |
Primary outcome
Bronkopulmoner Displazi under the corticosteroid
Time frame: 2 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Background: PubMed 11401896Jobe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevde Nur Vural, Asistant Dr principal investigator
KIRIKKALE UNİVERSİTY FACULTY OF MEDİCİNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia and Premature Birth, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronkopulmoner Displazi under the corticosteroid (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05621785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.