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Respiratory morbidity, including respiratory distress syndrome (RDS), is a serious complication of preterm birth and the leading cause of early neonatal mortality and disability. The effects of antenatal corticosteroid administration on fetal lung maturation have been widely studied in order to counteract such adverse perinatal outcomes of preterm birth. The dexamethasone regimen will be evaluated at different administration frequencies, but at the same total dose. The hypothesis is: The type of dexamethasone regimen administered for fetal lung maturation influences the incidence of perinatal complications.
Prematurity is a major obstacle to achieving goal 4 of the Millennium Development Goals, given its high contribution to neonatal mortality. The survival chances of premature babies vary significantly depending on where they are born. Preterm birth has remained the major contributor to neonatal morbidity and mortality worldwide, accounting for 70% of neonatal deaths.
As a management to reduce neonatal morbidity and mortality secondary to preterm birth, corticosteroid regimens have been established to accelerate fetal lung maturation. The reduction in perinatal complication rates has been widely observed, however, no differentiation has been observed between the incidence of complications according to the scheme applied.
Neonatal complications of preterm birth include respiratory distress syndrome, bronchopulmonary dysplasia, cystic periventricular leukomalacia, patent ductus arteriosus, sepsis, intraventricular hemorrhage, necrotizing enterocolitis, hypothermia, hypoglycemia, hyperbilirubinemia, and feeding difficulties. Long-term morbidity includes retinopathy of prematurity, neurodevelopmental impairment, and cerebral palsy. Of these, respiratory morbidity, including respiratory distress syndrome (RDS), is a serious complication of preterm birth and the leading cause of early neonatal mortality and disability.
Preterm birth rates are highest in low- and lower-middle-income countries (11.8% and 11.3% on average, respectively), while rates are lowest in upper-middle- and high-income countries ( 9.4% and 9.3%, respectively). More than 60% of all premature births worldwide occur in low-resource, high-fertility countries. In Honduras, a study carried out from 1998-2000 at the Maternal and Child Hospital by Portillo M. et al, reported a prevalence of preterm birth of 4.7% (1929 premature births out of 40,786 births).
Experimental. Single-blind, parallel-group, non-inferiority randomized clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group intervention (shortened dexamethasone regimen) | Experimental | Dexamethasone 12 mg IM every day for 2 days. Total dose: 24 mg |
|
| Group control (conventional dexamethasone regimen) | Active Comparator | Dexamethasone 6 mg IM every 12 hours for 2 days. Total dose: 24 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 12 mg QD | Drug | Administration of dexamethasone to the mother as an inducer of fetal lung maturity. shortened scheme |
|
| Measure | Description | Time Frame |
|---|---|---|
| neonatal complications | Presence or absence of respiratory distress syndrome, necrotizing enterocolitis, intraventricular hemorrhage, cystic ventricular leukomalacia, or death after receiving any of the different antenatal corticosteroid regimens | from the first intervention to Newborn discharge. on average less than 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal complications | Signs of maternal or neonatal infection determined clinically and laboratory after administration of corticosteroids. Maternal hyperglycemia or arterial hypertension. Fetal hypoglycemia. | rom the first intervention to birth. on average less than 28 days |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo A Gutierrez Ramirez, MD, MSc | Universidad Nacional Autonoma de Honduras | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Escuela | Tegucigalpa | Francisco Morazán Department | 11101 | Honduras |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32233700 | Background | Kastanek M, Frommlet F, Linsenmeier L, Helmer H. Influence of antenatal corticosteroid lung maturation on maternal inflammatory parameters. J Matern Fetal Neonatal Med. 2022 Mar;35(6):1210-1212. doi: 10.1080/14767058.2020.1743653. Epub 2020 Mar 31. | |
| 29779863 | Result | Vogel JP, Chawanpaiboon S, Moller AB, Watananirun K, Bonet M, Lumbiganon P. The global epidemiology of preterm birth. Best Pract Res Clin Obstet Gynaecol. 2018 Oct;52:3-12. doi: 10.1016/j.bpobgyn.2018.04.003. Epub 2018 Apr 26. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Experimental. Single-blind, parallel-group, non-inferiority randomized clinical trial.
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Both the patient and the principal investigator will know the intervention, the data analyst researcher does not know the group to which the patients have been assigned.
| Dexamethasone 6 mg BID | Drug | Administration of dexamethasone to the mother as an inducer of fetal lung maturity. standard Scheme |
|
| 23990333 | Result | Brownfoot FC, Gagliardi DI, Bain E, Middleton P, Crowther CA. Different corticosteroids and regimens for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2013 Aug 29;(8):CD006764. doi: 10.1002/14651858.CD006764.pub3. |
| D000091642 | Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |