Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Necrotizing Enterocolitis
Conditions
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
Interventions
Azithromicyn intravena for 14 days
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Two groups, one group intervention and one group control
Eligibility
Sex/Gender
ALL
Age
25 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* premature infant 25-31 weeks 6 days with respiratory distress,
Exclusion criteria
* multiple congenital anomaly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bronchopulmonaty Dysplasia | 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 | Use of oxygen suplemantation at least 28 days until 36 weeks PMA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraventricular hemorrhage | 1 days-7 days, and 6 weeks | 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 | 1 days-36 weeks PMA | 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 |
Countries
Indonesia
Outcome results
None listed