Adverse Neonatal Outcomes with a Shortened Clinical Regimen of Dexamethasone.

NCT06569251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-11-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dexamethasone 12 mg QD

Administration of dexamethasone to the mother as an inducer of fetal lung maturity. shortened scheme

DRUG

Dexamethasone 6 mg BID

Administration of dexamethasone to the mother as an inducer of fetal lung maturity. standard Scheme

Sponsors & Collaborators

  • Ricardo A Gutierrez Ramirez, MD, MSc, FACOG

    lead OTHER

Principal Investigators

  • Ricardo A Gutierrez Ramirez, MD, MSc · Universidad Nacional Autonoma de Honduras

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-11-24
Completion
2024-11-24

Countries

  • Honduras

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06569251 on ClinicalTrials.gov