Health Condition 1: null- Asymptomatic or symptomatic preterm neonates less than 34 weeks gestation
Conditions
Interventions
None listed
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1) Gestational age from 260/7 weeks to 33 6/7 weeks 2) Less than 24 hours old at time of enrollment 3) Either infant of a mother with PIH or infant who has a platelet count for a clinical indication and reported within 24 hours of life. 4) Echocardiographic evidence of patent ductus arteriosus done at 24±4 hours of age.
Exclusion criteria
Exclusion criteria: 1) Perinatal asphyxia (APGAR 2) Suspected congenital TORCH infection group; or proven congenital rubella infection, Cytomegalovirus51 infections 3) Echocardiographically proven congenital heart disease. Subjects with symptoms suggestive of congenital heart disease will undergo an echocardiogram by treating team. If this echocardiogram or the echocardiogram done as part of this research study shows a structural congenital heart disease, the subject will be excluded. 4) Clinical syndrome of early onset neonatal sepsis in the presence of risk factors and a chest x-ray consistent with pneumonia or a positive blood culture. 5) Major life-threatening malformation. 6) Clinically suspected syndromes that are known to have PDA- Char syndrome, Trisomy 21 and 18, CHARGE syndrome, Cri-du-chat syndrome, Noonan syndrome, and Holt-Oram syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable will be time to closure of the ductus for the first time.Timepoint: day 1 to 14 on daily basis | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. the proportion in whom the duct is open at 72 hoursTimepoint: 72 hours of life;2. the proportion in whom the duct is open at 7 daysTimepoint: 7 days of life;3. the proportion in whom the duct is haemodynamically significant at 72 hoursTimepoint: 72 hours of life;5. the proportion who need treatment for PDATimepoint: day 1 to 14 of life;among those treated with an NSAID, time to closure of the ductus after treatmentTimepoint: Day 1 to 14 of life;among those who receive a platelet transfusion, time to closure of the ductus after platelet transfusion for thrombocytopeniaTimepoint: Day 1 to 14 of life;the proportion in whom the duct is haemodynamically significant at 7 daysTimepoint: 7 days of life | — |
Countries
India
Contacts
Public ContactDrSourabh Dutta
PGIMER Chandigarh
Outcome results
None listed