Bronchopulmonary DysplasiaNCT05152316
The Baby Lung Study
An observational study of Bronchopulmonary Dysplasia and Neonatal Disease, run by University College, London at 1 site in United Kingdom.
Trial summary
The introduction of exogenous surfactant therapy has significantly improved the mortality in preterm infants born between 23- and 28-weeks of gestation. However, the therapy has not affected the prevalence of sequelae such as bronchopulmonary dysplasia [BPD] and it may be argued that it has actually increased. Read more about this study
- Who is it for?
- Ages 23 to 30 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia, Neonatal Disease
- What is being tested?
- Observational study
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Sep 2021to 31 May 2023
- 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 23 to 30 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants born between 23 + 0 weeks post menstrual age and 30 weeks post menstrual age.
Who may be able to join
- . Preterm infants born between 23 weeks and 0 days and 30 weeks and 0 days gestation.
Who cannot join
- Congenital anomalies i.e any major antenatal diagnosed congenital abnormalities such as congenital heart disease, suspected or known chromosomal abnormalities.
- Infants not born at UCLH where baseline data and samples cannot be collected
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospital
London, NW1 2PG
About this study
Official title: Inflammatory Markers and Surfactant Proteins in Preterm Infants at Risk of Developing Chronic Lung Disease: an Observational Study
The introduction of exogenous surfactant therapy has significantly improved the mortality in preterm infants born between 23- and 28-weeks of gestation. However, the therapy has not affected the prevalence of sequelae such as bronchopulmonary dysplasia [BPD] and it may be argued that it has actually increased. BPD is a lung condition that affects up to 40% of premature babies born between 23 and 28 weeks gestational age. The prevalence of BPD decreases with increasing gestational age but can affect infants born at term who have required mechanical ventilation. It is most commonly defined based on the need for oxygen past 36 weeks post-menstrual age [PMA]. The pathogenesis of BPD is multifactorial and involves a complex balance between the underdeveloped lungs, infection, inflammation, oxygen toxicity and ventilator induced injury.
In this study the investigators aim to develop a greater understanding of the interactions between the inflammatory markers present in endotracheal aspirates [ETA] and serum of preterm infants and surfactant components (including surfactant protein D-SP-D levels) in the lungs and in the serum of preterm ventilated infants.
Read more
The investigators aim to recruit infants born between 23+0 and 29+6 weeks of gestation at University College London Hospital admitted to the neonatal unit, who are at risk of developing respiratory distress syndrome [RDS] and progression to BPD. The investigators plan to study the correlation between the concentrations of surfactant components (in particular SP-D) and inflammatory markers in infants across the range of gestations specified. In order to do this, the investigators will obtain gastric aspirates, endotracheal aspirates [ETA] and blood samples at birth, 24hrs and days 2 through to day 7 from participants. ETA will only be obtained if the infants are intubated and ventilated, collected by a standard technique routinely used in nursing care of ventilated babies using 1-2mls of saline.ETA and blood samples will then be analysed for levels of surfactant proteins in particular SP-D and inflammatory and immunological markers [cell counts of neutrophils, macrophages, MMPs, neutrophil elastase, IL-8, IL-6, IL 11 and IL-1]. This will allow us to map the influence of SP-D on pro and anti-inflammatory markers that have a role in the inflammatory component of BPD in these infants.
Clinical data will also be collected at specified time points correlating with the plasma, gastric aspirates and endotracheal aspirates. The investigators aim to correlate clinical ventilatory parameters, infection factors and maternal factors with the inflammatory and surfactant protein profiles. In addition, the investigators will apply the international neonatal consortium Neonatal Adverse severity scores to gain a better understanding of the baseline incidence of adverse events in premature infants that are admitted to a neonatal unit.
- Conditions
- Bronchopulmonary Dysplasia, Neonatal Disease
- Being tested
- Observational study
- Medical subject headings
- Bronchopulmonary Dysplasia, Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
This is an observational study and no additional interventions will be done except for those that are standard care. Blood and tracheal aspirates will be taken to assess the surfactant protein levels and inflammatory markers including cell counts and cytokine levels.
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyses the profile of surfactant protein D in preterm infants at risk of bronchopulmonary dysplasia.
To measure the surfactant protein D levels in gastric and tracheal aspirates and plasma samples taken at birth, 24hrs, 48hrs, 72hrs, 96hrs, D7 of life and 36weeks post menstrual age if still intubated.
Measured: 24 months
Characterise the inflammatory cell profile in preterm infant at high risk of developing bronchopulmonary dysplasia.
To analyse the gastric and tracheal aspirates and plasma samples taken at birth, 24hrs, 48hrs, 72hrs, 96hrs, D7 of life and 36weeks post menstrual age if still intubated for cell counts (macrophages and neutrophils) to better understand the correlation with SP-D over a period of time.
Measured: 24 months
Characterise the cytokine profile in preterm infants at high risk of developing bronchopulmonary dysplasia.
To analyse the gastric and tracheal aspirates and plasma samples taken at birth, 24hrs, 48hrs, 72hrs, 96hrs, D7 of life and 36weeks post menstrual age if still intubated for pro- and anti-inflammatory cytokines to better understand the correlation with SP-D over a period of time.
Measured: 24 months
To understand the incidence of adverse events in preterm infants at risk of developing bronchopulmonary dysplasia.
To apply the Neonatal Adverse Events Severity Score developed by the International Neonatal Consortium to better evaluate the incidence of adverse events in this vulnerable population.
Measured: 24 months
Secondary outcomes (1)
Association of inflammatory profile and surfactant components with clinical parameters.
To study the association of the inflammatory profile and concentration of surfactant components with clinical factors comprising of baseline factors, such as infant sex, ethnicity, administration of antenatal steroids, evidence of maternal sepsis/chorioamnionitis, and treatment factors, such as ventilator settings and tracheal colonisation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start17 Sep 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Clark, Professor, Study chair, University College, LondonReena Bhatt, Dr, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152316
- Sponsor's protocol ID
- 138731
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data gathered will be the property of University College London and will not be shared with other research groups.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Markers and Surfactant Proteins in Preterm Infants at Risk of Developing Chronic Lung Disease: an Observational Study
- ClinicalTrials.gov ID
- NCT05152316
- Acronym / sponsor ID
- 138731
- Conditions
- Bronchopulmonary Dysplasia, Neonatal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 9 Dec 2021 (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.
The introduction of exogenous surfactant therapy has significantly improved the mortality in preterm infants born between 23- and 28-weeks of gestation. However, the therapy has not affected the prevalence of sequelae such as bronchopulmonary dysplasia [BPD] and it may be argued that it has actually increased. BPD is a lung condition that affects up to 40% of premature babies born between 23 and 28 weeks gestational age. The prevalence of BPD decreases with increasing gestational age but can affect infants born at term who have required mechanical ventilation. It is most commonly defined based on the need for oxygen past 36 weeks post-menstrual age [PMA]. The pathogenesis of BPD is multifactorial and involves a complex balance between the underdeveloped lungs, infection, inflammation, oxygen toxicity and ventilator induced injury.
In this study the investigators aim to develop a greater understanding of the interactions between the inflammatory markers present in endotracheal aspirates [ETA] and serum of preterm infants and surfactant components (including surfactant protein D-SP-D levels) in the lungs and in the serum of preterm ventilated infants.
The investigators aim to recruit infants born between 23+0 and 29+6 weeks of gestation at University College London Hospital admitted to the neonatal unit, who are at risk of developing respiratory distress syndrome [RDS] and progression to BPD. The investigators plan to study the correlation between the concentrations of surfactant components (in particular SP-D) and inflammatory markers in infants across the range of gestations specified. In order to do this, the investigators will obtain gastric aspirates, endotracheal aspirates [ETA] and blood samples at birth, 24hrs and days 2 through to day 7 from participants. ETA will only be obtained if the infants are intubated and ventilated, collected by a standard technique routinely used in nursing care of ventilated babies using 1-2mls of saline.ETA and blood samples will then be analysed for levels of surfactant proteins in particular SP-D and inflammatory and immunological markers [cell counts of neutrophils, macrophages, MMPs, neutrophil elastase, IL-8, IL-6, IL 11 and IL-1]. This will allow us to map the influence of SP-D on pro and anti-inflammatory markers that have a role in the inflammatory component of BPD in these infants.
Clinical data will also be collected at specified time points correlating with the plasma, gastric aspirates and endotracheal aspirates. The investigators aim to correlate clinical ventilatory parameters, infection factors and maternal factors with the inflammatory and surfactant protein profiles. In addition, the investigators will apply the international neonatal consortium Neonatal Adverse severity scores to gain a better understanding of the baseline incidence of adverse events in premature infants that are admitted to a neonatal unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 23 to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants born between 23 + 0 weeks post menstrual age and 30 weeks post menstrual age.
Key inclusion criteria (1 listed)
- . Preterm infants born between 23 weeks and 0 days and 30 weeks and 0 days gestation.
Key exclusion criteria (2 listed)
- Congenital anomalies i.e any major antenatal diagnosed congenital abnormalities such as congenital heart disease, suspected or known chromosomal abnormalities.
- Infants not born at UCLH where baseline data and samples cannot be collected
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 |
|---|---|---|
| Observational studyThis is an observational study and no additional interventions will be done except for those that are standard care. Blood and tracheal aspirates will be taken to assess the surfactant protein levels and inflammatory markers including cell counts and cytokine levels. | Other | – |
Primary outcome
To analyses the profile of surfactant protein D in preterm infants at risk of bronchopulmonary dysplasia.
Time frame: 24 months
To measure the surfactant protein D levels in gastric and tracheal aspirates and plasma samples taken at birth, 24hrs, 48hrs, 72hrs, 96hrs, D7 of life and 36weeks post menstrual age if still intubated.
Characterise the inflammatory cell profile in preterm infant at high risk of developing bronchopulmonary dysplasia.
Time frame: 24 months
To analyse the gastric and tracheal aspirates and plasma samples taken at birth, 24hrs, 48hrs, 72hrs, 96hrs, D7 of life and 36weeks post menstrual age if still intubated for cell counts (macrophages and neutrophils) to better understand the correlation with SP-D over a period of time.
Characterise the cytokine profile in preterm infants at high risk of developing bronchopulmonary dysplasia.
Time frame: 24 months
To analyse the gastric and tracheal aspirates and plasma samples taken at birth, 24hrs, 48hrs, 72hrs, 96hrs, D7 of life and 36weeks post menstrual age if still intubated for pro- and anti-inflammatory cytokines to better understand the correlation with SP-D over a period of time.
To understand the incidence of adverse events in preterm infants at risk of developing bronchopulmonary dysplasia.
Time frame: 24 months
To apply the Neonatal Adverse Events Severity Score developed by the International Neonatal Consortium to better evaluate the incidence of adverse events in this vulnerable population.
1 secondary outcome
Association of inflammatory profile and surfactant components with clinical parameters.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No. All data gathered will be the property of University College London and will not be shared with other research groups.
Related trials for Bronchopulmonary Dysplasia
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Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
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RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
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The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
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Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia
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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.
Howard Clark, Professor study chair
University College, London
Reena Bhatt, Dr principal investigator
University College, London
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 Neonatal Disease, run by University College, London at 1 site in United Kingdom.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 29 Nov 2023. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To analyses the profile of surfactant protein D in preterm infants at risk of bronchopulmonary dysplasia. (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2023.