Adverse Neonatal Outcomes with a Shortened Clinical Regimen of Dexamethasone. (UNODEXA)

November 24, 2024 updated by: Ricardo A Gutierrez Ramirez, MD, MSc, FACOG

Adverse Neonatal Outcomes with a Shortened Clinical Regimen of Dexamethasone: Single-blind Randomized Clinical Trial: UNODEXA Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Honduras
    • Francisco Morazan
      • Tegucigalpa, Francisco Morazan, Honduras, 11101
        • Hospital Escuela

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Delivery of a signed and dated informed consent form.
  2. Declared willingness to comply with all study procedures and availability during the duration of the study.
  3. Pregnant patient with 20 or more weeks of gestation determined by USG with clinically diagnosed threat of preterm labor (defined as uterine contractions with sufficient progressive frequency and intensity that allow dilation of the cervix before the 37th week of gestation).
  4. Pregnant patient admitted and birth in the Maternal and Child Hospital, Labor and Delivery room. Part.
  5. Delivery carried out at the Teaching Hospital.
  6. Patient with a diagnosis of premature rupture of membranes under conservative management.
  7. patient must know how to read and write
  8. Possess a cell phone or some other means of communication.
  9. Residing in the city of Tegucigalpa, Honduras.

Exclusion Criteria:

  1. Patients under 18 years of age.
  2. Patient with diagnosed psychiatric illnesses.
  3. Pregnant patient with threat of preterm birth who is also diagnosed with preeclampsia with data of severity and intrauterine growth restriction.
  4. Pregnant patient with threat of preterm birth who is also diagnosed with premature rupture of membranes.
  5. Pregnant patient with threat of preterm birth who is also diagnosed con corioamnionitis.
  6. Pregnant patient with threat of preterm birth who is also diagnosed with acute abdomen.
  7. Major fetal malformations
  8. Fetal death

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group intervention (shortened dexamethasone regimen)
Dexamethasone 12 mg IM every day for 2 days. Total dose: 24 mg
Drug: Dexamethasone 12 mg QD
Administration of dexamethasone to the mother as an inducer of fetal lung maturity. shortened scheme
Active Comparator: Group control (conventional dexamethasone regimen)
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. standard Scheme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neonatal complications
Time Frame: from the first intervention to Newborn discharge. on average less than 28 days
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal complications
Time Frame: rom the first intervention to birth. on average less than 28 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ricardo A Gutierrez Ramirez, MD, MSc, FACOG

Investigators

  • Study Director: Ricardo A Gutierrez Ramirez, MD, MSc, Universidad Nacional Autonoma de Honduras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

November 24, 2024

Study Completion (Actual)

November 24, 2024

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 24, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGO-UNAH-47-1-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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