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This study aims to determine the effectiveness of antenatal corticosteroid therapy in late preterm babies. The investigators hypothesis is corticoid accelerates fetal lung maturation even after 34 weeks and reduces risk of respiratory distress syndrome and other neonatal morbidities.
Late preterm babies have important morbidity when compared with term babies, with oxygen requirement and more days of hospitalization. If antenatal corticosteroid therapy is necessary for fetal lung maturation after 34 weeks, it remains to be established. The systematic review with metanalysis in Cochrane Library includes a small number of late preterm babies and no conclusion about effectiveness of corticoid therapy in this setting could be drawn. Our hypothesis is that antenatal corticosteroid therapy is effective to prevent respiratory disease and morbidity in late preterm babies and this study will be carried out to evaluate this question.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Antenatal corticoid therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethasone | Drug | IM administration of 12mg of betamethasone each 24 hours (total dose=24mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| neonatal respiratory distress | neonatal period (28 days of life) |
| Measure | Description | Time Frame |
|---|---|---|
| during of neonatal hospitalization | neonatal period (28 days of life) | |
| neonatal oxygen requirement | neonatal period (28 days of life) | |
| neonatal sepsis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melania Amorim, MD, PhD | Instituto Materno Infantil Prof. Fernando Figueira | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Materno Infantil Prof. Fernando Figueira | Recife | Pernambuco | 50070550 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21487057 | Derived | Porto AM, Coutinho IC, Correia JB, Amorim MM. Effectiveness of antenatal corticosteroids in reducing respiratory disorders in late preterm infants: randomised clinical trial. BMJ. 2011 Apr 12;342:d1696. doi: 10.1136/bmj.d1696. |
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| ID | Term |
|---|---|
| D006819 | Hyaline Membrane Disease |
| D012128 | Respiratory Distress Syndrome |
| D066087 | Perinatal Death |
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| C018230 | betamethasone acetate phosphate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| neonatal period (28 days of life) |
| neonatal death | neonatal period (28 days of life) |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |