A study on efficacy of Dexamethasone in prevention of transient tachypnoea of newbor
- Registration Number
- CTRI/2023/06/053731
- Lead Sponsor
- KMCT MEDICAL COLLEGE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Mothers with age between 18 years and 45 years are selected and those satisfying the inclusion criteria are enrolled
Inclusion criteria
1 Early term babies (37+0 to 38+6 weeks)
2 Appropriate for gestational age (AGA) babies (It refers to a baby who is born with a weight between 10th and 90th percentile on the intergrowth 21 chart for gestational age and sex)
3 No antenatal risk factors for respiratory morbidity.
Exclusion criteria
1 All preterm babies ( <37 weeks)
2 All term babies (=39 weeks)
3 All babies who have already received a course of antenatal steroids
4 All women who don’t have their gestational age confirmed via a first trimester’s dating scan
5 Multiple gestations
6 Risk factors like
Preeclampsia
Gestational diabetes mellitus (GDM) or pre-existing diabetes mellitus.
Maternal chorioamnionitis
Chronic hypertension, chronic renal disease, liver disease.
Prenatal ultrasonographic findings, such as oligohydramnios and structural lung disorders
Suspected intrauterine infections and fetus with major congenital anomalies or intrauterine growth restrictions
Meconium stained amniotic fluid (Grade I meconium stained liquor is translucent, light yellow green in colour, grade II MSL is opalescent with deep green and light yellow in colour, Grade III is opaque and deep green in colour)
Women who had hypersensitivities to dexamethasone/betamethasone or if the women came in labour prior to their scheduled elective CS date.
Perinatal asphyxia
7 General anesthesia and intraoperative maternal hypoxia
8 SGA and LGA babies
Small for gestational age (SGA) refers to a baby who is born with a weight below the 10th percentile on the intergrowth 21 chart for gestational age and sex.
Large for gestational age (LGA) refers to a baby who is born with a weight above the 90th percentile on the intergrowth 21 chart for gestational age and sex.
9 Mothers who have not given consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Any form of respiratory distress assessed in the form of APGAR score 7, Downes score 2 or more <br/ ><br>Timepoint: Apgar scores at 1 and 5 min of life calculated. <br/ ><br>oxygen saturation monitored at 5 and 10 min and general physical examination done. Downes score will be calculated. <br/ ><br>Repeated assessment will be done at 2, 4,6, 12, 24 hours of life. Neonates are kept under observation for a total of 24 hours.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are severity of respiratory distress, hypoglycemia and level of care in response. <br/ ><br> <br/ ><br>Timepoint: Neonates will be assessed at 0, 2, 4, 6, 12, 24, 48 hours of life.