CClinicalTrials.gg
Status unknownNCT04555889Updated Sep 21, 2020

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

An interventional study of lung recruitment maneuver (LRM) with DrageerVN500 in Bronchopulmonary Dysplasia, sponsored by Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K). Status unknown. Open to participants aged Up to 48 Hours. Per ClinicalTrials.gov, last updated 2020-09-21.

Sponsored by Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K) · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
Up to 48 Hours
Sex
All
01

Study 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. 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.
Read the detailed description

description of the protocol :

  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
02

Conditions studied

  • Bronchopulmonary Dysplasia

Keywords

  • lung recruitment maneuver
  • preterm babies
  • Bronchopulmonary dysplasia
03

In context

Bronchopulmonary Dysplasia

339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.

This study's planned enrollment of 110 is above the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.

Browse Bronchopulmonary Dysplasia studies →

Lead sponsor

This is the only study on the registry with Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K) as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 48 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    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.

    Device: lung recruitment maneuver (LRM) with DrageerVN500

  • No intervention
    without lung recruitment maneuver (LRM) group

    Another group get standart protocol only.

Interventions

  • Devicelung recruitment maneuver (LRM) with DrageerVN500

    interventions involving device that may help to gradually lung development

06

What researchers measure

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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

  4. 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.

    Time frame: 12 weeks

  5. 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.

    Time frame: 12 weeks

  6. 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.

    Time frame: 12 weeks

  7. 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.

    Time frame: 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

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 22682464 ↗
  • 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. Erratum In: Lancet. 2017 May 13;389(10082):1884. doi: 10.1016/S0140-6736(17)31212-6. PubMed 27839855 ↗
  • Kumar A, Bhat BV. Epidemiology of respiratory distress of newborns. Indian J Pediatr. 1996 Jan-Feb;63(1):93-8. doi: 10.1007/BF02823875. PubMed 10829971 ↗
  • 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. PubMed 12538782 ↗
  • 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. PubMed 24277660 ↗
  • 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. PubMed 21944681 ↗
  • 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. PubMed 19000577 ↗
  • 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. PubMed 14586055 ↗
  • 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. PubMed 22952169 ↗
  • 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. PubMed 17872453 ↗
  • 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. Erratum In: Crit Care Med. 2016 Mar;44(3):e180. PubMed 26308427 ↗
  • 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. PubMed 10794783 ↗
  • 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. PubMed 16860155 ↗
  • 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. PubMed 24213917 ↗
  • 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. PubMed 21380992 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04555889
Lead sponsor
Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K)
Collaborators
Indonesian Medical Education and Research Institute
Responsible party
Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K) (Principal Investigator of Perinatology Division, Dr Cipto Mangunkusumo General Hospital) — Sponsor-investigator
First posted
Sep 21, 2020
Start date
Oct 31, 2020 (estimated)
Primary completion
Oct 31, 2022 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Sep 21, 2020

Study contacts

Dr. R. Adhi T Perma Iskandar, Sp.A (K)
Contact
adhitpi@gmail.com
+62 85779153162
DR.Dr. Risma K Kaban, Sp.A (K)
Contact
+62 816902051
Dr. R. Adhi T Perma Iskandar, Sp.A (K)
principal investigator · RSCMPerinatology

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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