Respiratory Distress of NewbornPhase 1NCT05841121
Antenatal Dexamethasone for Late Preterm Deliveries
A Phase 1 study testing Dexamethasone in people with Respiratory Distress of Newborn and Preterm Birth, run by Chulalongkorn University at 1 site in Vietnam.
Trial summary
The goal of this clinical trial is to compare dexamethasone in late preterm deliveries. The main questions it aims to answer are: Does antenatal dexamethasone reduce the need for respiratory support in late preterm infants? Does antenatal dexamethasone reduce neonatal morbidities and mortality? Does antenatal… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Respiratory Distress of Newborn, Preterm Birth
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteVietnam
- Study dates
- 25 Aug 2023to 30 Apr 2024
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 34+0/7 to 36+6/7 weeks
- Expected preterm delivery for any indications in the next 7 days.
Who cannot join
- Fetal death
- Severe fetal malformation
- Twin or multiple pregnancy
- Maternal contraindication to dexamethasone: hypersensitive with steroids, any infection
- Severe maternal conditions such as eclampsia, cardiac arrest, antepartum hemorrhage due to placenta previa or abruption
- Delivery estimated within 2 hours: total cervical dilation
- Received steroids within 1 week
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Danang HOspital for Women and Children
Da Nang, 550000
Danang HOspital for Women and Children, +84236 3957 777, benhvienphusannhi@danang.gov.vn
About this study
Official title: Antenatal Dexamethasone for Late Preterm Deliveries: a Randomized Controlled Trial
The goal of this clinical trial is to compare dexamethasone in late preterm deliveries. The main questions it aims to answer are: Does antenatal dexamethasone reduce the need for respiratory support in late preterm infants? Does antenatal dexamethasone reduce neonatal morbidities and mortality? Does antenatal dexamethasone reduce admission to Neonatal Intensive Care Unit and length of hospital stay? Participants will be allocated into 2 groups: intervention with dexamethasone IM and control (standard care). Investigators will compare these two groups to see if antenatal dexamethasone reduces the need for respiratory support in late preterm infants, neonatal morbidities and mortality, admission to NICU and length of hospital stay.
Read the detailed description
Study design: The study is a double-blinded randomized controlled trial, parallel group. The sequence of randomization will be generated by using an online tool (https://www.sealedenvelope.com/simple-randomiser/v1/lists) with 2 groups of treatments with ratio 1:1, block of variable size (2,4,6), list length 302, no stratification. After having a randomization sequence, the symbol of group (control or intervention) will be kept in a sealed envelope. These envelops will be also put in the order as the allocation sequence. Assessors and investigators will be blinded to the group allocation.
Participants: Participants are women with singleton pregnancy, from 18 to 45 years old, at 34+0/7 to 36+6/7 weeks of gestation and at high risk for delivery during the late preterm period in the next 7 days.
Intervention: Antenatal dexamethasone. Participants in the intervention group will be given a course of four intramuscular injections of dexamethasone 6 mg (1.2 milliliter), 12 hours apart.
Comparison: Standard care. Outcomes: Primary outcome: Need for any respiratory support in first 72 hours, which is determined when babies need to be supported with continuous positive airway pressure (CPAP), high-flow nasal cannula (HFNC), supplemental oxygen, or mechanical ventilation in first 72 hours to keep the saturation in a proper range (90-95%).
Sample size is 300 participants in 2 groups: intervention group and control group.
Place: The study will be conducted at Danang Hospital for Women and Children, Danang, Vietnam.
Eligibility of participants will be assessed at admission area of delivery department. One senior obstetrician will introduce the study to the patient by using the study information sheet. If the pregnant woman agrees to join in the research, the writen consent will be delivered to her and she will sign on it. When participants agrees, one sealed envelope with a number inside will be opened to allocate which group she involves. At that time, Eligibility criteria and Part 1 of the CRF will also be filled.
After randomization, pregnant women will be monitored at delivery rooms until delivery or c-section. After birth, both mother and baby will be closed monitored and assessed until transferred to post-natal wards or neonatal unit. Part 2. Labour and at birth Part 3. Newborn outcomes Part 4: Maternal outcomes will be collected.
If infants discharge before 28 days old, the follow-up section will be done at follow-up clinic of neonatal unit. Information about outcome (alive or death), any re-admission to hospital (number of time and reasons), and nutrition (types of milk (breast milk, formula milk or mix), feeding methods (breast feeding, bottle, tube/cup/spoon) will be collected for Part 5 of CRF.
- Conditions
- Respiratory Distress of Newborn, Preterm Birth
- Being tested
- Dexamethasone
- Keywords
- Late preterm infants, Respiratory distress
- Medical subject headings
- Pulmonary Atelectasis, Premature Birth, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Antenatal dexamethasone will be given a course of four intramuscular injections of dexamethasone 6 mg (1.2 milliliter), 12 hours apart.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone group | Experimental | The intervention is antenatal dexamethasone. Participants in the intervention group will be given a course of four intramuscular injections of dexamethasone 6 mg (1.2 milliliter), 12 hours apart. Receives: Drug: Dexamethasone |
| Control group | No intervention | Participants in the control group will be received standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of respiratory support
Rate of babies requiring any respiratory support such as continuous positive airway pressure (CPAP), high-flow nasal cannula (HFNC), supplemental oxygen, or mechanical ventilation in first 72 hours to keep the saturation in a proper range (90-95%).
Measured: First 72 hours of life
Secondary outcomes (5)
Neonatal respiratory morbidities
Rate of respiratory morbidities: RDS, TTN, Surfactant administration, Need for mechanical ventilation, Apnea, BPD
Measured: From birth to 28 days of life or death
Neonatal co-morbidities
Rate of co-morbidities: resuscitation after birth, other morbidities: Hypoglycemia, Hypothermia, Early onset infection, Late onset infection, Jaundice need phototherapy, IVH, NEC, Admission to NICU, Neonatal mortality; average hospital days
Measured: From birth to 28 days of life or death
Neonatal treatment outcomes
Rate of admission to NICU, Neonatal mortality rate, average hospital days
Measured: From birth to 28 days of life or death
Maternal secondary outcomes
Rate of maternal post-partum infection, rate of c-section
Measured: First week after delievery
Maternal outcomes
Average hospital days
Measured: First week after delievery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start25 Aug 2023
- Primary completion28 Mar 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress of NewbornStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are women with singleton pregnancy, from 18 to 45 years old, at 34+0/7 to 36+6/7 weeks of gestation and at high risk for delivery during the late preterm period in the next 7 days.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chau Hoang Minh Le, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841121
- Sponsor's protocol ID
- 49/2566
- Status last verified
- Feb 2024
- First submitted
- 3 Apr 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Le CHM, Tran HT, Huynh QK, Chaithongwongwatthana S. Impact of Antenatal Dexamethasone on Respiratory Outcomes in Late Preterm Infants in a Vietnamese Tertiary Hospital: A Randomised Controlled Trial. Acta Paediatr. 2026 Apr;115(4):887-893. doi: 10.1111/apa.70417. Epub 2025 Dec 26.
PubMed 41452963
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Dexamethasone for Late Preterm Deliveries: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05841121
- Acronym / sponsor ID
- 49/2566
- Conditions
- Respiratory Distress of Newborn, Preterm Birth
- Keywords
- Late preterm infants, Respiratory distress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 28 Mar 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 3 May 2023 (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.
The goal of this clinical trial is to compare dexamethasone in late preterm deliveries. The main questions it aims to answer are: Does antenatal dexamethasone reduce the need for respiratory support in late preterm infants? Does antenatal dexamethasone reduce neonatal morbidities and mortality? Does antenatal dexamethasone reduce admission to Neonatal Intensive Care Unit and length of hospital stay? Participants will be allocated into 2 groups: intervention with dexamethasone IM and control (standard care). Investigators will compare these two groups to see if antenatal dexamethasone reduces the need for respiratory support in late preterm infants, neonatal morbidities and mortality, admission to NICU and length of hospital stay.
Detailed description
Study design: The study is a double-blinded randomized controlled trial, parallel group. The sequence of randomization will be generated by using an online tool (https://www.sealedenvelope.com/simple-randomiser/v1/lists) with 2 groups of treatments with ratio 1:1, block of variable size (2,4,6), list length 302, no stratification. After having a randomization sequence, the symbol of group (control or intervention) will be kept in a sealed envelope. These envelops will be also put in the order as the allocation sequence. Assessors and investigators will be blinded to the group allocation.
Participants: Participants are women with singleton pregnancy, from 18 to 45 years old, at 34+0/7 to 36+6/7 weeks of gestation and at high risk for delivery during the late preterm period in the next 7 days.
Intervention: Antenatal dexamethasone. Participants in the intervention group will be given a course of four intramuscular injections of dexamethasone 6 mg (1.2 milliliter), 12 hours apart.
Comparison: Standard care. Outcomes: Primary outcome: Need for any respiratory support in first 72 hours, which is determined when babies need to be supported with continuous positive airway pressure (CPAP), high-flow nasal cannula (HFNC), supplemental oxygen, or mechanical ventilation in first 72 hours to keep the saturation in a proper range (90-95%).
Sample size is 300 participants in 2 groups: intervention group and control group.
Place: The study will be conducted at Danang Hospital for Women and Children, Danang, Vietnam.
Eligibility of participants will be assessed at admission area of delivery department. One senior obstetrician will introduce the study to the patient by using the study information sheet. If the pregnant woman agrees to join in the research, the writen consent will be delivered to her and she will sign on it. When participants agrees, one sealed envelope with a number inside will be opened to allocate which group she involves. At that time, Eligibility criteria and Part 1 of the CRF will also be filled.
After randomization, pregnant women will be monitored at delivery rooms until delivery or c-section. After birth, both mother and baby will be closed monitored and assessed until transferred to post-natal wards or neonatal unit. Part 2. Labour and at birth Part 3. Newborn outcomes Part 4: Maternal outcomes will be collected.
If infants discharge before 28 days old, the follow-up section will be done at follow-up clinic of neonatal unit. Information about outcome (alive or death), any re-admission to hospital (number of time and reasons), and nutrition (types of milk (breast milk, formula milk or mix), feeding methods (breast feeding, bottle, tube/cup/spoon) will be collected for Part 5 of CRF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are women with singleton pregnancy, from 18 to 45 years old, at 34+0/7 to 36+6/7 weeks of gestation and at high risk for delivery during the late preterm period in the next 7 days.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone group | Experimental | Drug: DexamethasoneThe intervention is antenatal dexamethasone. Participants in the intervention group will be given a course of four intramuscular injections of dexamethasone 6 mg (1.2 milliliter), 12 hours apart. |
| Control group | No intervention | –Participants in the control group will be received standard care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 34+0/7 to 36+6/7 weeks
- Expected preterm delivery for any indications in the next 7 days.
Key exclusion criteria (7 listed)
- Fetal death
- Severe fetal malformation
- Twin or multiple pregnancy
- Maternal contraindication to dexamethasone: hypersensitive with steroids, any infection
- Severe maternal conditions such as eclampsia, cardiac arrest, antepartum hemorrhage due to placenta previa or abruption
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 |
|---|---|---|
| DexamethasoneAntenatal dexamethasone will be given a course of four intramuscular injections of dexamethasone 6 mg (1.2 milliliter), 12 hours apart. | Drug | Dexamethasone group |
Primary outcome
Rate of respiratory support
Time frame: First 72 hours of life
Rate of babies requiring any respiratory support such as continuous positive airway pressure (CPAP), high-flow nasal cannula (HFNC), supplemental oxygen, or mechanical ventilation in first 72 hours to keep the saturation in a proper range (90-95%).
5 secondary outcomes
Neonatal respiratory morbidities
Time frame: From birth to 28 days of life or death
Neonatal co-morbidities
Time frame: From birth to 28 days of life or death
Neonatal treatment outcomes
Time frame: From birth to 28 days of life or death
Maternal secondary outcomes
Time frame: First week after delievery
Maternal outcomes
Time frame: First week after delievery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 41452963Le CHM, Tran HT, Huynh QK, Chaithongwongwatthana S. Impact of Antenatal Dexamethasone on Respiratory Outcomes in Late Preterm Infants in a Vietnamese Tertiary Hospital: A Randomised Controlled Trial. Acta Paediatr. 2026 Apr;115(4):887-893. doi: 10.1111/apa.70417. Epub 2025 Dec 26.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone in people with Respiratory Distress of Newborn and Preterm Birth, run by Chulalongkorn University at 1 site in Vietnam.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Feb 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 Vietnam. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chau Le, PhD (+84905983797, lhmchau@dhktyduocdn.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of respiratory support (time frame: First 72 hours of life). 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 NCT05841121, which also lists 1 linked publication.
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 8 Feb 2024.