The Impact of Lung Recruitment Maneuver in 24-32 Weekers, & the Incidence

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04555889
Study type	Interventional
Source	Dr Cipto Mangunkusumo General Hospital
Contact	Dr. R. Adhi T Perma Iskandar, Sp.A (K)
Phone	+62 85779153162
Email	adhitpi@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	October 31, 2020
Completion date	December 30, 2022

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04506619` - Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Completed	`NCT04936477` - Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants	N/A
Recruiting	`NCT05285345` - Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Completed	`NCT03649932` - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing	Phase 1
Terminated	`NCT02524249` - Early Versus Late Caffeine for ELBW Newborns	N/A
Completed	`NCT02249143` - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants	N/A
Active, not recruiting	`NCT01632475` - Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Completed	`NCT01460576` - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt	N/A
Completed	`NCT00419588` - Growth of Airways and Lung Tissues in Premature and Healthy Infants
Unknown status	`NCT00254176` - Cysteine Supplementation in Critically Ill Neonates	Phase 2/Phase 3
Completed	`NCT00208039` - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates	N/A
Completed	`NCT00319956` - Trial II of Lung Protection With Azithromycin in the Preterm Infant	Phase 2
Completed	`NCT00006401` - Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants	Phase 3
Terminated	`NCT05030012` - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants	N/A
Completed	`NCT00006058` - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns	N/A
Completed	`NCT00005376` - Premature Birth and Its Sequelae in Women	N/A
Completed	`NCT00011362` - Dexamethasone Therapy in VLBW Infants at Risk of CLD	Phase 3
Completed	`NCT00004805` - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death	N/A
Completed	`NCT05152316` - The Baby Lung Study
Recruiting	`NCT04821453` - NAVA vs. CMV Crossover in Severe BPD	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms