The Impact of Lung Recruitment Maneuver in 24-32 Weekers, and the Incidence of Bronchopulmonary Dysplasia

NCT04555889 | Unknown

• 1 other identifier: Med. Fac. of Univ. Indonesia
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

hypothesis :

1. 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. 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. 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. 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. 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. 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.

Conditions

Bronchopulmonary Dysplasia

Keywords

lung recruitment maneuver; preterm babies; Bronchopulmonary dysplasia

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  12 weeks

• Knowing the relationship between lung recruitment maneuver in 24-32 weekers, with their lung endothel intergrity (serum levels of CD-31+)

  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-)

  12 weeks

• Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their micro circulation (oxygen index)

  12 weeks

• Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their their micro circulation (tc-pCO2 - PaCO2 index)

  12 weeks

Study Arms (2)

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.

Device: lung recruitment maneuver (LRM) with DrageerVN500

without lung recruitment maneuver (LRM) group

NO INTERVENTION

Another group get standart protocol only.

Interventions

lung recruitment maneuver (LRM) with DrageerVN500 DEVICE

interventions involving device that may help to gradually lung development

lung recruitment maneuver (LRM) group

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K): lead
• Indonesia Medical Education and Research Institute: collaborator

Related Publications (15)

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  PMID: 12538782 RESULT

• 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.

  PMID: 24277660 RESULT

• 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.

  PMID: 21944681 RESULT

• 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.

  PMID: 19000577 RESULT

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  PMID: 14586055 RESULT

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  PMID: 17872453 RESULT

• 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.

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  PMID: 24213917 RESULT

• 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.

  PMID: 21380992 RESULT

Related Links

• 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

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

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

Study Officials

• Dr. R. Adhi T Perma Iskandar, Sp.A (K)

  RSCMPerinatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. R. Adhi T Perma Iskandar, Sp.A (K)

CONTACT

+62 85779153162; adhitpi@gmail.com

DR.Dr. Risma K Kaban, Sp.A (K)

CONTACT

+62 816902051

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: * All babies wether they experience the intervention ofr not they can not tell to other peoples. * Only The lab analyzer will be blind to the subject of study, other measurement can not be blind.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator of Perinatology Division

Model Details: 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

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: September 21, 2020
• Study Start: October 31, 2020
• Primary Completion: October 31, 2022
• Study Completion: December 30, 2022
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share