A Phase 2 interventional study of Dexamethasone 12 mg QD and Dexamethasone 6 mg BID in Preterm Birth and Distress Respiratory Syndrome, sponsored by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG. Completed at 1 site in Honduras. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG · Phase 2, Interventional, and Treatment
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.
2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's enrollment of 68 is below the median of 84 across 1,722 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Ricardo A Gutierrez Ramirez, MD, MSc, FACOG is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Dexamethasone 12 mg IM every day for 2 days. Total dose: 24 mg
Drug: Dexamethasone 12 mg QD
Dexamethasone 6 mg IM every 12 hours for 2 days. Total dose: 24 mg.
Drug: Dexamethasone 6 mg BID
Administration of dexamethasone to the mother as an inducer of fetal lung maturity. shortened scheme
Administration of dexamethasone to the mother as an inducer of fetal lung maturity. standard Scheme
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
Time frame: from the first intervention to Newborn discharge. on average less than 28 days
Maternal complications
Signs of maternal or neonatal infection determined clinically and laboratory after administration of corticosteroids. Maternal hyperglycemia or arterial hypertension. Fetal hypoglycemia.
Time frame: rom the first intervention to birth. on average less than 28 days
Plan to share: No
Ran from Mar 2024 to primary completion in Nov 2024, 8 months.
Of 32 non-industry phase 2 interventional studies under Premature Birth, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 45. This study's 8 months is below that.
Counting every sponsor, half of 40 studies reached it within 34 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dexamethasone
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG