Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569251
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Adverse Neonatal Outcomes With a Shortened Clinical Regimen of Dexamethasone
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adverse Neonatal Outcomes With a Shortened Clinical Regimen of Dexamethasone Single-blind Randomized Clinical Trial UNODEXA Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UNODEXA
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 118 and 113 on average respectively while rates are lowest in upper-middle- and high-income countries 94 and 93 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 47 1929 premature births out of 40786 births
Experimental Single-blind parallel-group non-inferiority randomized clinical trial
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 118 and 113 on average respectively while rates are lowest in upper-middle- and high-income countries 94 and 93 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 47 1929 premature births out of 40786 births
Experimental Single-blind parallel-group non-inferiority randomized clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None