The Impact of Lung Recruitment Maneuver in 24-32 Weekers, and the Incidence of Bronchopulmonary Dysplasia
NCT ID: NCT04555889
Last Updated: 2020-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2020-10-31
2022-12-30
Brief Summary
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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. 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.
3. 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.
4. 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
5. 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.
6. 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.
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Detailed Description
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1. 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.
2. 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.
3. 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.
4. After that babies will observe within 28 days to detect Bronchopulmonary dysplasia
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
* Only The lab analyzer will be blind to the subject of study, other measurement can not be blind.
Study Groups
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lung recruitment maneuver (LRM) group
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.
lung recruitment maneuver (LRM) with DrageerVN500
interventions involving device that may help to gradually lung development
without lung recruitment maneuver (LRM) group
Another group get standart protocol only.
No interventions assigned to this group
Interventions
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lung recruitment maneuver (LRM) with DrageerVN500
interventions involving device that may help to gradually lung development
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
48 Hours
ALL
No
Sponsors
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Indonesia Medical Education and Research Institute
OTHER
Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K)
OTHER
Responsible Party
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Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K)
Principal Investigator of Perinatology Division
Principal Investigators
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Dr. R. Adhi T Perma Iskandar, Sp.A (K)
Role: PRINCIPAL_INVESTIGATOR
RSCMPerinatology
Central Contacts
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DR.Dr. Risma K Kaban, Sp.A (K)
Role: CONTACT
References
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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.
Liu 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.
Kumar A, Bhat BV. Epidemiology of respiratory distress of newborns. Indian J Pediatr. 1996 Jan-Feb;63(1):93-8. doi: 10.1007/BF02823875.
van 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.
Peng 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.
DiBlasi 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.
Haczku 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.
Eisner 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.
Reid 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.
Woodfin 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.
Cabrera-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.
Kluckow 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.
Bancalari 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.
Madurga 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.
Castoldi 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.
Related Links
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Heated, humidified high-flow nasal cannula vs. nasal CPAP in infants with moderate respiratory distress
Experimental Ventilator-induced Lung Injury: Exacerbation by Positive End-Expiratory Pressure
Transitional Hemodynamics in Preterm Neonates: Clinical Relevance
Other Identifiers
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Med. Fac. of Univ. Indonesia
Identifier Type: -
Identifier Source: org_study_id
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