Neonatal Respiratory Distress Syndrome Clinical Trial
Official title:
Effect of Antenatal Corticosteroids on Neonatal Morbidity.
Verified date | December 2019 |
Source | Ahmadu Bello University Teaching Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | May 31, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Nigeria | Ahmadu Bello University Teaching Hospital Shika-Zaria | Zaria | Kaduna |
Lead Sponsor | Collaborator |
---|---|
Ahmadu Bello University Teaching Hospital |
Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neonatal Respiratory distress syndrome | Tachypnoea with grunting, recession, or nasal flaring with diffuse reticulogranular infiltrate on X-ray and oxygen requirement. | Within the first 72 hours of life | |
Secondary | Transient tachypnoea of the newborn: | As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital | Within the first 72 hours after delivery/birth | |
Secondary | Admission into neonatal intensive care unit. | As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital | Within the first 72 hours after delivery/birth | |
Secondary | 2. Admission into neonatal intensive care unit. Apnoea. | As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital | Within the first 72 hours after delivery/birth |
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