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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone sodium phosphate injection | Experimental | Intervention: Drug: Dexamethasone sodium phosphate injection Two doses Intramuscular Dexamethasone sodium phosphate 12mg given12 hours apart. (produced by Taizhou Overseas International Ltd. 126-128 Qingnian Road Jiaojiang, Taizhou, Zhejiang, China) |
|
| Betamethasone sodium phosphate injection | Experimental | Intervention: Drug: Betamethasone sodium phosphate injection Two doses of intramuscular betamethasone sodium phosphate 12mg given 12 hours apart. (obtained from Twinbrook pkwy, Rockville, MD Singapore. CAT No 1068004, Lot: R004e0) |
|
| Water for injection | Placebo Comparator | Intervention. Drug: Water for injection. Two doses of intramuscular water for injection given 12 hours apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Sodium Phosphate Injection | Drug | Dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Admission into neonatal intensive care unit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anisah Yahya, MBBS | Ahmadu Bello University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmadu Bello University Teaching Hospital Shika-Zaria | Zaria | Kaduna State | PMB 06 | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38952884 | Derived | Yahya A, Sulayman HU, Abdulkadir I, Lawal BB. Effect of Antenatal Corticosteroids in Late Preterm Delivery on Neonatal Respiratory Morbidity: A Randomized Controlled Trial. Niger Med J. 2023 Oct 21;64(4):532-544. doi: 10.60787/NMJ-64-4-297. eCollection 2023 Jul-Aug. |
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The outcome will be shared
Data will be made available 6 months after completion and will be made available for 6 months
It will be shared on request
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| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| C004180 | dexamethasone 21-phosphate |
| C028994 | betamethasone sodium phosphate |
| D004304 | Dosage Forms |
| D014867 | Water |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D006878 | Hydroxides |
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Randomised controlled trial
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double blind
|
| Betamethasone Sodium Phosphate Injection (Medication) | Drug | betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart |
|
| Water for injection | Drug | Two doses of intramuscular injection of water for injection given 12 hours apart |
|
|
As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital
| Within the first 72 hours after delivery/birth |
| 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 |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |