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

September 14, 2020 updated by: Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K)

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 days (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
interventions involving device that may help to gradually lung development
NO_INTERVENTION: without lung recruitment maneuver (LRM) group
Another group get standart protocol only.

What is the study measuring?

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
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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+)
Time Frame: 12 weeks
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-)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will make right and left cardiac output higher compare to control.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Indonesian Medical Education and Research Institute

Investigators

  • Principal Investigator: Dr. R. Adhi T Perma Iskandar, Sp.A (K), RSCMPerinatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 31, 2020

Primary Completion (ANTICIPATED)

October 31, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (ACTUAL)

September 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Med. Fac. of Univ. Indonesia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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