Health Condition 1: P53- Hemorrhagic disease of newborn
Conditions
Interventions
Intervention1: 0.3 mg intramuscular vitamin K: 0.3 mg intramuscular vitamin K is given within 1 hour of admission in the NICU
Intervention2: 1 mg intramuscular vitamin K: 1 mg intramuscular vitamin K
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: Preterm neonates less than 32 weeks of gestation and/or less than 1500 g born during the study period
Exclusion criteria
Exclusion criteria: Outborn neonates who already received vitamin K, those with antenatally diagnosed major congenital malformations and intracranial hemorrhage, neonates whose mothers had thrombophilia or platelet disorders, and who received drug treatment with known vitamin K antagonists.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of PIVKA-II levels among study groups on day 5 of life.Timepoint: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of PIVKA-II levels on day 28 of life, 2. Proportion of vitamin K sufficient infants on days 5 and 28. 3. Clinical morbidities: Cranial ultrasound abnormalities, peak bilirubin levels and duration of phototherapy, pulmonary haemorrhage, necrotizing enterocolitis (NEC), and mortalityTimepoint: Day 5, Day 28, Time of admission till discharge | — |
Countries
India
Contacts
Public ContactGiridhar S
Chettinad Hospital and Research Institute
Outcome results
None listed