Clinical trial NCT04555889: The Impact of Lung Recruitment Maneuver in 24-32 Weekers, and the Incidence of Bronchopulmonary Dysplasia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Keywords: lung recruitment maneuver
preterm babies
Bronchopulmonary dysplasia
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
Collaborators: name: Indonesia Medical Education and Research Institute
First posted: 2020-09-21
Enrollment: 110
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with the incidence of Bronchopulmonary dysplasia
timeFrame: 12 weeks
Secondary outcomes:
measure: Knowing the relationship between lung recruitment maneuver in 24-32 weekers, with their alveolar intergrity (serum levels of surfactan protein-D)
timeFrame: 12 weeks
measure: Knowing the relationship between lung recruitment maneuver in 24-32 weekers, with their lung endothel intergrity (serum levels of CD-31+)
timeFrame: 12 weeks
measure: Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their lung endothel intergrity (serum levels of CD-42b-)
timeFrame: 12 weeks
measure: Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their micro circulation (oxygen index)
timeFrame: 12 weeks
measure: Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their their micro circulation (tc-pCO2 - PaCO2 index)
timeFrame: 12 weeks
measure: Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their incidence patent ductus arteriosus (PDA) significant
timeFrame: 12 weeks
measure: Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their macro circulation
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: RSCMPerinatology
name: Dr. R. Adhi T Perma Iskandar, Sp.A (K)
role: PRINCIPAL_INVESTIGATOR
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