Health Condition 1: null- Premature neonates at birth
Conditions
Interventions
Intervention1: Lower dose paracetamol group: This group will receive intravenous paracetamol in dosage of 10mg/kg/dose 4 times a day for 3 days
Control Intervention1: Higher dose paracetamol group: Th
Sponsors
Surya Childrens Medicare Private limited
Eligibility
Inclusion criteria
Inclusion criteria: Preterm infants with a) gestation age less than 28weeks or b) between 28-30 weeks on invasive mechanical ventilation or on CPAP with FiO2 requirements more than 35% AND having 2D echocardiographic evidence of hemodynamically significant PDA (duct size more than 1.5mm narrowest internal diameter, Left Atrium/Aorta more than 1.5, left to right flow across shunt, reversal of flow in distal aorta) diagnosed at 18-24 hours of life.
Exclusion criteria
Exclusion criteria: 1. Infants having complex cyanotic heart disease or duct dependent cardiac lesion. 2. Infants who were admitted to hospital after 72 hours of life. 3. Infants perceived unlikely to survive the first week of life. 4. Antenatal diagnosed serious congenital anomaly such as multicystic dysplastic kidney and polycystic disease of kidney) 5. maternal tocolytic therapy with indomethacin or another prostaglandin inhibitor within 72 hrs prior to delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PDA closure rate in low dose and high dose paracetamol group. PDA closure is defined as absence of flow through the ductus.Timepoint: Day 6 of life | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause Mortality.Timepoint: During NICU stay;Bronchopulmonary dysplasiaTimepoint: During NICU stay;Duct reopening rate.Timepoint: During NICU stay;Duration of hospital stayTimepoint: NICU stay;Intraventricular hemorrhage (all grades and grade 3 and grade 4)Timepoint: During NICU stay;NEC (grade 2 and 3)Timepoint: During NICU stay;Number of days on invasive mechanical ventilation/ NIV/ oxygen therapyTimepoint: During NICU stay;Periventricular leukomalaciaTimepoint: During NICU stay;Rate of adverse effects (increased S.creatinine {more than 1 mg%}, oliguria {urine output less than 0.5ml/kg/hr for 6 hours}, increased transaminases level {more than 2 times ULN}, thrombocytopenia {platelet count less than 100000/mm3}, gastrointestinal hemorrhage).Timepoint: end of first week of life;Requirement of ibuprofen/indomethacinTimepoint: During NICU stay;Requirement of multiple courses/higher dosesTimepoint: During NICU stay;Retinopathy of prematurity requiring treatment (injection avastin or laser)Timepoint: During NICU stay;Surgical ligation rate.Timepoint: During NICU stay | — |
Countries
India
Contacts
Public ContactDr Vaibhav Jain
Surya Childrens Medicare Pvt Ltd
Outcome results
None listed