Health Condition 1: P221- Transient tachypnea of newborn
Conditions
Interventions
Intervention1: IV Furosemide: Participants will be randomized into one of three study arms. The three arms IV furosemide, oral furosemide, and placebo will be coded as A, B, or C, and all neonates wil
the oral arm receives oral furosemide (1 mg/kg in expressed breast milk) with IV normal saline placebo (1 ml/kg/dose)
and the placebo arm receives both oral breast-milk placebo and IV normal saline placebo, with equivalent volumes adjusted from maintenance fluids. Study drugs and placebos will be prepared by independ
if tachypnea persists 12 hours after the first dose, a second dose of the assigned intervention will be administered (maximum two doses). The study endpoint will be sustained resolution of respiratory
the oral arm
Sponsors
Dr S Thanigainathan
Eligibility
Inclusion criteria
Inclusion criteria: All neonates born in AIIMS Bibinagar more than or equal to 34 weeks of gestation admitted to NICU with clinical diagnosis of TTNB
Exclusion criteria
Exclusion criteria: Suspected Early onset sepsis (risk factors including Maternal infection or chorioamnionitis, Prolonged rupture of membranes more than 24h, Preterm Premature rupture of membranes, Unsterile Vaginal examination, Prolonged labor stage 1 and 2 more thabn 24h, severe perinatal asphyxia Major Congenital malformations Meconium aspiration or significant parenchymal disease on CXR Polycythemia, Hypoglycemia Parents denied consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to resolution, in hours of tachypnea or respiratory distress sustained for 24h.Timepoint: Outcome will be assessed at the time point when respiratory distress resolves | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the highest level of respiratory support required (room air, nasal cannula, HFNC, CPAP, or mechanical ventilation) among study groups .Timepoint: till discharge;To compare the total duration of respiratory support (in hours) required by neonates in each study group from randomizationTimepoint: Until complete resolution of respiratory distress;To compare changes in serum electrolytes (sodium and potassium) and renal function parameters (serum urea and creatinine)Timepoint: 24h and 48h of life;To compare the duration of hospital stay (in days) among study groupsTimepoint: At Discharge;To compare the cumulative percentage weight loss every dayTimepoint: At 72h of life or discharge;To compare the maximum fraction of inspired oxygen FiO2 requirement among study groupsTimepoint: During Hospital Stay | — |
Countries
India
Contacts
Public ContactDr Gurarsh Singh
All India Institute of Medical Sciences, Bibinagar
Outcome results
None listed