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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Bronchopulmonary Dysplasia

Intervention / Treatment
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* Device: lung recruitment maneuver (LRM) with DrageerVN500


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lung recruitment maneuver (LRM) group<br>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<br>* interventions involving device that may help to gradually lung development<br>|
| No Intervention: without lung recruitment maneuver (LRM) group<br>Another group get standart protocol only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung recruitment maneuver, preterm babies, Bronchopulmonary dysplasia