The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant
Primary Purpose
Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Necrotizing Enterocolitis
Status
Recruiting
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Azithromycin Powder
Sponsored by
About this trial
This is an interventional prevention trial for Bronchopulmonary Dysplasia
Eligibility Criteria
Inclusion Criteria:
- premature infant 25-31 weeks 6 days with respiratory distress,
Exclusion Criteria:
- multiple congenital anomaly
Sites / Locations
- University of IndonesiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Intervention group will give azithromycin for 14 days, 7 days 10 mg/body weight/24 hours, 7 days 5 mg/bw/hours
No intervention
Outcomes
Primary Outcome Measures
Bronchopulmonaty Dysplasia
Use of oxygen suplemantation at least 28 days until 36 weeks PMA
Secondary Outcome Measures
Intraventricular hemorrhage
Sign of IVH from head ultrasonography from USG we can found the sign of IVH grade 1 if we perform head USG and we found bleeding in germinal matriks grade 2 if we perform head USG and we found bleeding intaventricular without ventricle dilatation grade 3 if we perform head USG we found bleeding intraventrucular with dilatation of ventricle grade 4 if we perform head USG and we found bleeding in parenchime
Head USG perform at 1-7 days and then in 6 weeks
Necrotizing Enterocolitis
Sign and symptoms of NEC from clinical, laboratory, and radiology
If we found :
From clinical sign : temperature < 36.5 degree C or > 37.5 degree C, Respiratory rate > 60/min with retraction, abdominal distention Laboratory examination : trombocyte < 100.000/mm3, natrium <135 meq/L, pH < 7.1, BE > -12, CRP > 5 IU Radiology examination : sign of pneumatosis intestinalis
NEC : clinically + laboratory + radiology
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05311228
Brief Title
The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant
Official Title
The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was to see the effectiveness of azithromycin in preventing the incidence of bronchopulmonary dysphasia in extremely preterm and very premature infants. Inclusion criteria were infants with a gestational age of 25-31 weeks 6 days who experienced respiratory distress and their families had agreed to participate in the study, then randomized. The intervention was in the form of giving azithromycin in the intervention group and no intervention was carried out in the control group and then followed up to 36 weeks PMA
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Necrotizing Enterocolitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Two groups, one group intervention and one group control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention group will give azithromycin for 14 days, 7 days 10 mg/body weight/24 hours, 7 days 5 mg/bw/hours
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Azithromycin Powder
Intervention Description
Azithromicyn intravena for 14 days
Primary Outcome Measure Information:
Title
Bronchopulmonaty Dysplasia
Description
Use of oxygen suplemantation at least 28 days until 36 weeks PMA
Time Frame
BPD mild room air until 36 weeks PMA, BPD moderate use of oxygen <30% until 36 weeks PMA, BPD severe use of oxygen >30% until 36 weeks PMA
Secondary Outcome Measure Information:
Title
Intraventricular hemorrhage
Description
Sign of IVH from head ultrasonography from USG we can found the sign of IVH grade 1 if we perform head USG and we found bleeding in germinal matriks grade 2 if we perform head USG and we found bleeding intaventricular without ventricle dilatation grade 3 if we perform head USG we found bleeding intraventrucular with dilatation of ventricle grade 4 if we perform head USG and we found bleeding in parenchime
Head USG perform at 1-7 days and then in 6 weeks
Time Frame
1 days-7 days, and 6 weeks
Title
Necrotizing Enterocolitis
Description
Sign and symptoms of NEC from clinical, laboratory, and radiology
If we found :
From clinical sign : temperature < 36.5 degree C or > 37.5 degree C, Respiratory rate > 60/min with retraction, abdominal distention Laboratory examination : trombocyte < 100.000/mm3, natrium <135 meq/L, pH < 7.1, BE > -12, CRP > 5 IU Radiology examination : sign of pneumatosis intestinalis
NEC : clinically + laboratory + radiology
Time Frame
1 days-36 weeks PMA
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
25 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
premature infant 25-31 weeks 6 days with respiratory distress,
Exclusion Criteria:
multiple congenital anomaly
Facility Information:
Facility Name
University of Indonesia
City
Jakarta
State/Province
DKI Jakarta
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Besse Sarmila
Phone
081342540966
Email
prajautama.84@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Maybe i will share IPD with other researcher
Learn more about this trial
The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant
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