Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT06569251
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT06569251
Study Brief:
Protocol Section:
NCT06569251