Neonatal Respiratory Distress Syndrome
Conditions
Keywords
Antenal corticosteroids, Late preterm delivery, Neonatal morbidity
Brief summary
It will be a randomized controlled trial. There will be two study groups. Study group 1 will be given dexamethasone while study group 2 will be given betamethasone. The control group will be given placebo.
Detailed description
The study will be a double blind randomised controlled trial. There will be two study groups and one control group. The first study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular dexamethasone sodium phosphate. The second study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular betamethasone sodium phosphate. The control group will be pregnant women at risk of late preterm birth that will be given intramuscular water for injection.
Interventions
Dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart
DRUGBetamethasone Sodium Phosphate Injection (Medication)
betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart
Two doses of intramuscular injection of water for injection given 12 hours apart
Sponsors
Ahmadu Bello University Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
double blind
Intervention model description
Randomised controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation and a probability of delivery in the late preterm period irrespective of diagnosis who give consent. * Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation scheduled for elective/emergency delivery in the late preterm period irrespective of indication and route of delivery who give consent.
Exclusion criteria
* Evidence of Chrioamnionitis. * Evidence of foetal distress. * History of use of antenatal corticosteroids in index pregnancy. * Women who do not give consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Respiratory distress syndrome | Within the first 72 hours of life | Tachypnoea with grunting, recession, or nasal flaring with diffuse reticulogranular infiltrate on X-ray and oxygen requirement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transient tachypnoea of the newborn: | Within the first 72 hours after delivery/birth | As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital |
| Admission into neonatal intensive care unit. | Within the first 72 hours after delivery/birth | As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital |
| 2. Admission into neonatal intensive care unit. Apnoea. | Within the first 72 hours after delivery/birth | As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital |
Countries
Nigeria
Outcome results
None listed