Bronchopulmonary DysplasiaNCT04555889
The Impact of Lung Recruitment Maneuver in 24-32 Weekers, and the Incidence of Bronchopulmonary Dysplasia
A study testing lung recruitment maneuver (LRM) with DrageerVN500 in people with Bronchopulmonary Dysplasia, run by Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K).
Trial summary
hypothesis : 1. The incident of dysplasia bronchopulmonary and/or death in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control. 2. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- lung recruitment maneuver (LRM) with DrageerVN500
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2020to 30 Dec 2022
- Phase
- Interventional
- 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 Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 24-32 weeks preterm babies.
- Babies on assist-control volume guarantee ventilation with FiO2 > 30% to reach oxygen saturations within 90-95%.
- Age less than 48 hours.
- Born in Cipto Mangunkusumo Hospital and Bunda Menteng Hospital.
- Parents/guardians agreed to participate in this study with sign informed consent.
Who cannot join
- Weight birth <750 grams.
- APGAR score at 10 minutes are <5.
- Born with congenital heart disease except patent ductus arteriosus or presistence foramen ovale.
- Born with congenital disorder that need surgery intervention (for example :
- diaphragmatic hernia, atresia ani, esophageal atresia, duodenal atresia.
- Born with congenital disorder that worsening of the respiratory distress (for example
- hydrops fetalis, phrenic nerve paralysis, abnormality of chest wall, abnormality of air way (for example : Choanal atresia, Laryngeal stenosis, cleft palate.
- Born inborn error metabolism disease.
Trial locations and contacts
No sites are listed yet.
DR.Dr. Risma K Kaban, Sp.A (K) contact
About this study
Official title: The Impact of Lung Recruitment Maneuver in 24-32 Weeks Preterm Babies With Assist-control Volume Guarantee Mode to Their Hemodynamic Status and the Incidence of Bronchopulmonary Dysplasia
hypothesis :
- The incident of dysplasia bronchopulmonary and/or death in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
- The serum levels of surfactant protein-D in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
- The serum concentration of CD-31+ and CD-42b- in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
- The right and left cardiac output in 24-32 weekers babies on assist-control volume guarantee mode are more higher in lung recruitment maneuver (LRM) group, than group that did not get LRM
- The incident Patent Ductus Arteriosus in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
- The difference tc-pCO2 - PaCO2 , tcO2 index , and strong ion difference (SID) in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
Read the detailed description
description of the protocol :
- All Babies that meet inclusion criteria would immediately given surfactan. Babies will do echocardiography, blood gas analize, blood sample, transcutaneous monitor. After that babies will be randomized, the intervention group will get standart protocol + lung recruitment maneuver (LRM) and another group get standart protocol only.
- The lung recruitment maneuver (LRM) will be done by increasing of PEEP 0,2 cm H2O every 3 minutes, until reach the opening pressure. After that PEEP decrease gradually until get the closing pressure. Than the investigators will back to the opening pressure for 3 minutes, and the final PEEP will be put back 0,2 above closing pressure.
- After 3rd days (72 hours) babies, the investigators will exime serum levels of surfactan protein-D, CD-31+ and CD-42b- , blood gas , tc-pCO2 - PaCO2 , tcO2 index.
- After that babies will observe within 28 days to detect Bronchopulmonary dysplasia
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- lung recruitment maneuver (LRM) with DrageerVN500
- Keywords
- lung recruitment maneuver, preterm babies, Bronchopulmonary dysplasia
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung recruitment maneuver (LRM) with DrageerVN500Device
interventions involving device that may help to gradually lung development
| Study group | Role | What they receive |
|---|---|---|
| lung recruitment maneuver (LRM) group | Experimental | The lung recruitment maneuver (LRM) will be done by increasing of PEEP 0,2 cm H2O every 3 minutes, until reach the opening pressure. After that PEEP decrease gradually until get the closing pressure. Than the investigators will back to the opening pressure for 3 minutes, and the final PEEP will be put backo 0,2 above closing pressure. Receives: Device: lung recruitment maneuver (LRM) with DrageerVN500 |
| without lung recruitment maneuver (LRM) group | No intervention | Another group get standart protocol only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with the incidence of Bronchopulmonary dysplasia
Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower incidence of Bronchopulmonary dysplasia compare to control.
Measured: 12 weeks
Secondary outcomes (7)
Knowing the relationship between lung recruitment maneuver in 24-32 weekers, with their alveolar intergrity (serum levels of surfactan protein-D)
Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower serum levels of surfactan protein -D compare to control.
Measured: 12 weeks
Knowing the relationship between lung recruitment maneuver in 24-32 weekers, with their lung endothel intergrity (serum levels of CD-31+)
Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower serum concentrarion of CD-31+ compare to control.
Measured: 12 weeks
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their lung endothel intergrity (serum levels of CD-42b-)
Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower serum concentrarion of CD-42b- compare to control.
Measured: 12 weeks
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their micro circulation (oxygen index)
Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have higher oxygen index compare to control.
Measured: 12 weeks
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their their micro circulation (tc-pCO2 - PaCO2 index)
preterm babies ( 24-32 weeks) with Lung Recrutment manuver will have transcutaneous-arterial partial carbon dioxide gap lower than control ( less than 6 mmHg ). babies with better microcirculation status will show less than 6 mmHg transcutaneous-arterial partial carbon dioxide gap.
Measured: 12 weeks
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their incidence patent ductus arteriosus (PDA) significant
Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will make lower incident of Patent Ductus Arteriosus compare to control.
Measured: 12 weeks
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their macro circulation
Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will make right and left cardiac output higher compare to control.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start31 Oct 2020 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The impact of lung recruitment maneuver in 24-32 weekers with assist-control volume guarantee mode to their hemodynamic status and the incidence of Bronchopulmonary dysplasia
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K)
- Sponsor type
- University, hospital or other
- Collaborators
- Indonesia Medical Education and Research Institute
- Responsible party
- Sponsor-investigator, Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K), Dr Cipto Mangunkusumo General Hospital
- Investigators
- Dr. R. Adhi T Perma Iskandar, Sp.A (K), Principal investigator, RSCMPerinatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555889
- Sponsor's protocol ID
- Med. Fac. of Univ. Indonesia
- Status last verified
- Sep 2020
- First submitted
- 12 Aug 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, Adler A, Vera Garcia C, Rohde S, Say L, Lawn JE. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012 Jun 9;379(9832):2162-72. doi: 10.1016/S0140-6736(12)60820-4.
PubMed 22682464Liu L, Oza S, Hogan D, Chu Y, Perin J, Zhu J, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of under-5 mortality in 2000-15: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet. 2016 Dec 17;388(10063):3027-3035. doi: 10.1016/S0140-6736(16)31593-8. Epub 2016 Nov 11.
PubMed 27839855Kumar A, Bhat BV. Epidemiology of respiratory distress of newborns. Indian J Pediatr. 1996 Jan-Feb;63(1):93-8. doi: 10.1007/BF02823875.
PubMed 10829971van Kaam AH, de Jaegere A, Haitsma JJ, Van Aalderen WM, Kok JH, Lachmann B. Positive pressure ventilation with the open lung concept optimizes gas exchange and reduces ventilator-induced lung injury in newborn piglets. Pediatr Res. 2003 Feb;53(2):245-53. doi: 10.1203/01.PDR.0000047520.44168.22.
PubMed 12538782Peng W, Zhu H, Shi H, Liu E. Volume-targeted ventilation is more suitable than pressure-limited ventilation for preterm infants: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F158-65. doi: 10.1136/archdischild-2013-304613. Epub 2013 Nov 25.
PubMed 24277660DiBlasi RM. Neonatal noninvasive ventilation techniques: do we really need to intubate? Respir Care. 2011 Sep;56(9):1273-94; discussion 1295-7. doi: 10.4187/respcare.01376.
PubMed 21944681Haczku A. Protective role of the lung collectins surfactant protein A and surfactant protein D in airway inflammation. J Allergy Clin Immunol. 2008 Nov;122(5):861-79; quiz 880-1. doi: 10.1016/j.jaci.2008.10.014.
PubMed 19000577Eisner MD, Parsons P, Matthay MA, Ware L, Greene K; Acute Respiratory Distress Syndrome Network. Plasma surfactant protein levels and clinical outcomes in patients with acute lung injury. Thorax. 2003 Nov;58(11):983-8. doi: 10.1136/thorax.58.11.983.
PubMed 14586055Reid VL, Webster NR. Role of microparticles in sepsis. Br J Anaesth. 2012 Oct;109(4):503-13. doi: 10.1093/bja/aes321. Epub 2012 Sep 4.
PubMed 22952169Woodfin A, Voisin MB, Nourshargh S. PECAM-1: a multi-functional molecule in inflammation and vascular biology. Arterioscler Thromb Vasc Biol. 2007 Dec;27(12):2514-23. doi: 10.1161/ATVBAHA.107.151456. Epub 2007 Sep 13.
PubMed 17872453Cabrera-Benitez NE, Valladares F, Garcia-Hernandez S, Ramos-Nuez A, Martin-Barrasa JL, Martinez-Saavedra MT, Rodriguez-Gallego C, Muros M, Flores C, Liu M, Slutsky AS, Villar J. Altered Profile of Circulating Endothelial-Derived Microparticles in Ventilator-Induced Lung Injury. Crit Care Med. 2015 Dec;43(12):e551-9. doi: 10.1097/CCM.0000000000001280.
PubMed 26308427Kluckow M, Evans N. Superior vena cava flow in newborn infants: a novel marker of systemic blood flow. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F182-7. doi: 10.1136/fn.82.3.f182.
PubMed 10794783Bancalari E, Claure N. Definitions and diagnostic criteria for bronchopulmonary dysplasia. Semin Perinatol. 2006 Aug;30(4):164-70. doi: 10.1053/j.semperi.2006.05.002.
PubMed 16860155Madurga A, Mizikova I, Ruiz-Camp J, Morty RE. Recent advances in late lung development and the pathogenesis of bronchopulmonary dysplasia. Am J Physiol Lung Cell Mol Physiol. 2013 Dec;305(12):L893-905. doi: 10.1152/ajplung.00267.2013. Epub 2013 Nov 8.
PubMed 24213917Castoldi F, Daniele I, Fontana P, Cavigioli F, Lupo E, Lista G. Lung recruitment maneuver during volume guarantee ventilation of preterm infants with acute respiratory distress syndrome. Am J Perinatol. 2011 Aug;28(7):521-8. doi: 10.1055/s-0031-1272970. Epub 2011 Mar 4.
PubMed 21380992
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Lung Recruitment Maneuver in 24-32 Weeks Preterm Babies With Assist-control Volume Guarantee Mode to Their Hemodynamic Status and the Incidence of Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT04555889
- Acronym / sponsor ID
- Med. Fac. of Univ. Indonesia
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- lung recruitment maneuver, preterm babies, Bronchopulmonary dysplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K)University, hospital or other
- Collaborators
- Indonesia Medical Education and Research Institute
- Study start
- 31 Oct 2020 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 21 Sep 2020 (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.
hypothesis :
- The incident of dysplasia bronchopulmonary and/or death in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
- The serum levels of surfactant protein-D in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
- The serum concentration of CD-31+ and CD-42b- in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
- The right and left cardiac output in 24-32 weekers babies on assist-control volume guarantee mode are more higher in lung recruitment maneuver (LRM) group, than group that did not get LRM
- The incident Patent Ductus Arteriosus in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
- The difference tc-pCO2 - PaCO2 , tcO2 index , and strong ion difference (SID) in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
Detailed description
description of the protocol :
- All Babies that meet inclusion criteria would immediately given surfactan. Babies will do echocardiography, blood gas analize, blood sample, transcutaneous monitor. After that babies will be randomized, the intervention group will get standart protocol + lung recruitment maneuver (LRM) and another group get standart protocol only.
- The lung recruitment maneuver (LRM) will be done by increasing of PEEP 0,2 cm H2O every 3 minutes, until reach the opening pressure. After that PEEP decrease gradually until get the closing pressure. Than the investigators will back to the opening pressure for 3 minutes, and the final PEEP will be put back 0,2 above closing pressure.
- After 3rd days (72 hours) babies, the investigators will exime serum levels of surfactan protein-D, CD-31+ and CD-42b- , blood gas , tc-pCO2 - PaCO2 , tcO2 index.
- After that babies will observe within 28 days to detect Bronchopulmonary dysplasia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The impact of lung recruitment maneuver in 24-32 weekers with assist-control volume guarantee mode to their hemodynamic status and the incidence of Bronchopulmonary dysplasia
| Arm | Type | Receives |
|---|---|---|
| lung recruitment maneuver (LRM) group | Experimental | Device: lung recruitment maneuver (LRM) with DrageerVN500The lung recruitment maneuver (LRM) will be done by increasing of PEEP 0,2 cm H2O every 3 minutes, until reach the opening pressure. After that PEEP decrease gradually until get the closing pressure. Than the investigators will back to the opening pressure for 3 minutes, and the final PEEP will be put backo 0,2 above closing pressure. |
| without lung recruitment maneuver (LRM) group | No intervention | –Another group get standart protocol only. |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 24-32 weeks preterm babies.
- Babies on assist-control volume guarantee ventilation with FiO2 > 30% to reach oxygen saturations within 90-95%.
- Age less than 48 hours.
- Born in Cipto Mangunkusumo Hospital and Bunda Menteng Hospital.
- Parents/guardians agreed to participate in this study with sign informed consent.
Key exclusion criteria (8 listed)
- Weight birth <750 grams.
- APGAR score at 10 minutes are <5.
- Born with congenital heart disease except patent ductus arteriosus or presistence foramen ovale.
- Born with congenital disorder that need surgery intervention (for example :
- diaphragmatic hernia, atresia ani, esophageal atresia, duodenal atresia.
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 recruitment maneuver (LRM) with DrageerVN500interventions involving device that may help to gradually lung development | Device | lung recruitment maneuver (LRM) group |
Primary outcome
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with the incidence of Bronchopulmonary dysplasia
Time frame: 12 weeks
Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower incidence of Bronchopulmonary dysplasia compare to control.
7 secondary outcomes
Knowing the relationship between lung recruitment maneuver in 24-32 weekers, with their alveolar intergrity (serum levels of surfactan protein-D)
Time frame: 12 weeks
Knowing the relationship between lung recruitment maneuver in 24-32 weekers, with their lung endothel intergrity (serum levels of CD-31+)
Time frame: 12 weeks
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their lung endothel intergrity (serum levels of CD-42b-)
Time frame: 12 weeks
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their micro circulation (oxygen index)
Time frame: 12 weeks
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their their micro circulation (tc-pCO2 - PaCO2 index)
Time frame: 12 weeks
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their incidence patent ductus arteriosus (PDA) significant
Time frame: 12 weeks
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their macro circulation
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Results publication: PubMed 22682464Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, Adler A, Vera Garcia C, Rohde S, Say L, Lawn JE. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012 Jun 9;379(9832):2162-72. doi: 10.1016/S0140-6736(12)60820-4.
- Results publication: PubMed 27839855Liu L, Oza S, Hogan D, Chu Y, Perin J, Zhu J, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of under-5 mortality in 2000-15: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet. 2016 Dec 17;388(10063):3027-3035. doi: 10.1016/S0140-6736(16)31593-8. Epub 2016 Nov 11.
- Results publication: PubMed 10829971Kumar A, Bhat BV. Epidemiology of respiratory distress of newborns. Indian J Pediatr. 1996 Jan-Feb;63(1):93-8. doi: 10.1007/BF02823875.
- Results publication: PubMed 12538782van Kaam AH, de Jaegere A, Haitsma JJ, Van Aalderen WM, Kok JH, Lachmann B. Positive pressure ventilation with the open lung concept optimizes gas exchange and reduces ventilator-induced lung injury in newborn piglets. Pediatr Res. 2003 Feb;53(2):245-53. doi: 10.1203/01.PDR.0000047520.44168.22.
- Results publication: PubMed 24277660Peng W, Zhu H, Shi H, Liu E. Volume-targeted ventilation is more suitable than pressure-limited ventilation for preterm infants: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F158-65. doi: 10.1136/archdischild-2013-304613. Epub 2013 Nov 25.
- Results publication: PubMed 21944681DiBlasi RM. Neonatal noninvasive ventilation techniques: do we really need to intubate? Respir Care. 2011 Sep;56(9):1273-94; discussion 1295-7. doi: 10.4187/respcare.01376.
- Results publication: PubMed 19000577Haczku A. Protective role of the lung collectins surfactant protein A and surfactant protein D in airway inflammation. J Allergy Clin Immunol. 2008 Nov;122(5):861-79; quiz 880-1. doi: 10.1016/j.jaci.2008.10.014.
- Results publication: PubMed 14586055Eisner MD, Parsons P, Matthay MA, Ware L, Greene K; Acute Respiratory Distress Syndrome Network. Plasma surfactant protein levels and clinical outcomes in patients with acute lung injury. Thorax. 2003 Nov;58(11):983-8. doi: 10.1136/thorax.58.11.983.
- Results publication: PubMed 22952169Reid VL, Webster NR. Role of microparticles in sepsis. Br J Anaesth. 2012 Oct;109(4):503-13. doi: 10.1093/bja/aes321. Epub 2012 Sep 4.
- Results publication: PubMed 17872453Woodfin A, Voisin MB, Nourshargh S. PECAM-1: a multi-functional molecule in inflammation and vascular biology. Arterioscler Thromb Vasc Biol. 2007 Dec;27(12):2514-23. doi: 10.1161/ATVBAHA.107.151456. Epub 2007 Sep 13.
- Results publication: PubMed 26308427Cabrera-Benitez NE, Valladares F, Garcia-Hernandez S, Ramos-Nuez A, Martin-Barrasa JL, Martinez-Saavedra MT, Rodriguez-Gallego C, Muros M, Flores C, Liu M, Slutsky AS, Villar J. Altered Profile of Circulating Endothelial-Derived Microparticles in Ventilator-Induced Lung Injury. Crit Care Med. 2015 Dec;43(12):e551-9. doi: 10.1097/CCM.0000000000001280.
- Results publication: PubMed 10794783Kluckow M, Evans N. Superior vena cava flow in newborn infants: a novel marker of systemic blood flow. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F182-7. doi: 10.1136/fn.82.3.f182.
- Heated, humidified high-flow nasal cannula vs. nasal CPAP in infants with moderate respiratory distressLink provided by the sponsor.
- Experimental Ventilator-induced Lung Injury: Exacerbation by Positive End-Expiratory PressureLink provided by the sponsor.
- Transitional Hemodynamics in Preterm Neonates: Clinical RelevanceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
DR.Dr. Risma K Kaban, Sp.A (K) contact
Dr. R. Adhi T Perma Iskandar, Sp.A (K) principal investigator
RSCMPerinatology
Questions about this trial
What is this clinical trial studying?
A study testing lung recruitment maneuver (LRM) with DrageerVN500 in people with Bronchopulmonary Dysplasia, run by Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K).
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 5 inclusion and 8 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 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Dr. R. Adhi T Perma Iskandar, Sp.A (K) (+62 85779153162, adhitpi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with the incidence of Bronchopulmonary dysplasia (time frame: 12 weeks). 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 NCT04555889, which also lists 15 linked publications.
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 21 Sep 2020.