Preterm BirthPhase 2UNODEXANCT06569251
Adverse Neonatal Outcomes With a Shortened Clinical Regimen of Dexamethasone.
A Phase 2 study testing Dexamethasone 12 mg QD and Dexamethasone 6 mg BID in people with Preterm Birth and Distress Respiratory Syndrome, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 1 site in Honduras.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Distress Respiratory Syndrome
- What is being tested?
- Dexamethasone 12 mg QD and Dexamethasone 6 mg BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteHonduras
- Study dates
- 1 Mar 2024to 24 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Delivery of a signed and dated informed consent form.
- Declared willingness to comply with all study procedures and availability during the duration of the study.
- 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).
- Pregnant patient admitted and birth in the Maternal and Child Hospital, Labor and Delivery room. Part.
- Delivery carried out at the Teaching Hospital.
- Patient with a diagnosis of premature rupture of membranes under conservative management.
Show all 9Show fewer
- patient must know how to read and write
- Possess a cell phone or some other means of communication.
- Residing in the city of Tegucigalpa, Honduras.
Who cannot join
- Patients under 18 years of age.
- Patient with diagnosed psychiatric illnesses.
- Pregnant patient with threat of preterm birth who is also diagnosed with preeclampsia with data of severity and intrauterine growth restriction.
- Pregnant patient with threat of preterm birth who is also diagnosed with premature rupture of membranes.
- Pregnant patient with threat of preterm birth who is also diagnosed con corioamnionitis.
- Pregnant patient with threat of preterm birth who is also diagnosed with acute abdomen.
- Major fetal malformations
- Fetal death
Trial locations and contacts
1 site in 1 country.
Honduras1 site
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, 11101
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Birth, Distress Respiratory Syndrome
- Being tested
- Dexamethasone 12 mg QD, Dexamethasone 6 mg BID
- Keywords
- preterm birth, Dexamethasone
- Medical subject headings
- Premature Birth, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 12 mg QDDrug
Administration of dexamethasone to the mother as an inducer of fetal lung maturity. shortened scheme
Dexamethasone 6 mg BIDDrug
Administration of dexamethasone to the mother as an inducer of fetal lung maturity. standard Scheme
| Study group | Role | What they receive |
|---|---|---|
| Group intervention (shortened dexamethasone regimen) | Experimental | Dexamethasone 12 mg IM every day for 2 days. Total dose: 24 mg Receives: Drug: Dexamethasone 12 mg QD |
| Group control (conventional dexamethasone regimen) | Active comparator | Dexamethasone 6 mg IM every 12 hours for 2 days. Total dose: 24 mg. Receives: Drug: Dexamethasone 6 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from the first intervention to Newborn discharge. on average less than 28 days
Secondary outcomes (1)
Maternal complications
Signs of maternal or neonatal infection determined clinically and laboratory after administration of corticosteroids. Maternal hyperglycemia or arterial hypertension. Fetal hypoglycemia.
Measured: rom the first intervention to birth. on average less than 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Mar 2024
- Primary completion24 Nov 2024
- Study completion24 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental. Single-blind, parallel-group, non-inferiority randomized clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
- Investigators
- Ricardo A Gutierrez Ramirez, MD, MSc, Study director, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569251
- Sponsor's protocol ID
- PGO-UNAH-47-1-2024
- Acronym
- UNODEXA
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kastanek M, Frommlet F, Linsenmeier L, Helmer H. Influence of antenatal corticosteroid lung maturation on maternal inflammatory parameters. J Matern Fetal Neonatal Med. 2022 Mar;35(6):1210-1212. doi: 10.1080/14767058.2020.1743653. Epub 2020 Mar 31.
PubMed 32233700Vogel JP, Chawanpaiboon S, Moller AB, Watananirun K, Bonet M, Lumbiganon P. The global epidemiology of preterm birth. Best Pract Res Clin Obstet Gynaecol. 2018 Oct;52:3-12. doi: 10.1016/j.bpobgyn.2018.04.003. Epub 2018 Apr 26.
PubMed 29779863Brownfoot FC, Gagliardi DI, Bain E, Middleton P, Crowther CA. Different corticosteroids and regimens for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2013 Aug 29;(8):CD006764. doi: 10.1002/14651858.CD006764.pub3.
PubMed 23990333
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Neonatal Outcomes With a Shortened Clinical Regimen of Dexamethasone: Single-blind Randomized Clinical Trial: UNODEXA Trial
- ClinicalTrials.gov ID
- NCT06569251
- Acronym / sponsor ID
- UNODEXA / PGO-UNAH-47-1-2024
- Conditions
- Preterm Birth, Distress Respiratory Syndrome
- Keywords
- preterm birth, Dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOGUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 24 Nov 2024 (actual)
- Study completion
- 24 Nov 2024 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental. Single-blind, parallel-group, non-inferiority randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Group intervention (shortened dexamethasone regimen) | Experimental | Drug: Dexamethasone 12 mg QDDexamethasone 12 mg IM every day for 2 days. Total dose: 24 mg |
| Group control (conventional dexamethasone regimen) | Active comparator | Drug: Dexamethasone 6 mg BIDDexamethasone 6 mg IM every 12 hours for 2 days. Total dose: 24 mg. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Delivery of a signed and dated informed consent form.
- Declared willingness to comply with all study procedures and availability during the duration of the study.
- 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).
- Pregnant patient admitted and birth in the Maternal and Child Hospital, Labor and Delivery room. Part.
- Delivery carried out at the Teaching Hospital.
Key exclusion criteria (8 listed)
- Patients under 18 years of age.
- Patient with diagnosed psychiatric illnesses.
- Pregnant patient with threat of preterm birth who is also diagnosed with preeclampsia with data of severity and intrauterine growth restriction.
- Pregnant patient with threat of preterm birth who is also diagnosed with premature rupture of membranes.
- Pregnant patient with threat of preterm birth who is also diagnosed con corioamnionitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 12 mg QDAdministration of dexamethasone to the mother as an inducer of fetal lung maturity. shortened scheme | Drug | Group intervention (shortened dexamethasone regimen) |
| Dexamethasone 6 mg BIDAdministration of dexamethasone to the mother as an inducer of fetal lung maturity. standard Scheme | Drug | Group control (conventional dexamethasone regimen) |
Primary outcome
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
1 secondary outcome
Maternal complications
Time frame: rom the first intervention to birth. on average less than 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 32233700Kastanek M, Frommlet F, Linsenmeier L, Helmer H. Influence of antenatal corticosteroid lung maturation on maternal inflammatory parameters. J Matern Fetal Neonatal Med. 2022 Mar;35(6):1210-1212. doi: 10.1080/14767058.2020.1743653. Epub 2020 Mar 31.
- Results publication: PubMed 29779863Vogel JP, Chawanpaiboon S, Moller AB, Watananirun K, Bonet M, Lumbiganon P. The global epidemiology of preterm birth. Best Pract Res Clin Obstet Gynaecol. 2018 Oct;52:3-12. doi: 10.1016/j.bpobgyn.2018.04.003. Epub 2018 Apr 26.
- Results publication: PubMed 23990333Brownfoot FC, Gagliardi DI, Bain E, Middleton P, Crowther CA. Different corticosteroids and regimens for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2013 Aug 29;(8):CD006764. doi: 10.1002/14651858.CD006764.pub3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo A Gutierrez Ramirez, MD, MSc study director
Universidad Nacional Autonoma de Honduras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone 12 mg QD and Dexamethasone 6 mg BID in people with Preterm Birth and Distress Respiratory Syndrome, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neonatal complications (time frame: from the first intervention to Newborn discharge. on average less than 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06569251, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.