Infant, PrematurePhase 3NCT07052201
Dexamethasone Regimens for BPD Prevention in Preterm Infants
A Phase 3 study testing Dexamethasone. Dart and Dexametasone. Medium in people with Infant, Premature and Bronchopulmonary Dysplasia (BPD), run by The Children's Hospital of Zhejiang University School of Medicine at 24 sites in China.
Trial summary
The goal of this clinical trial is to compare the effectiveness of two different dexamethasone treatment regimens (the DART regimen and the medium-dose tapering regimen) in reducing the incidence of Bronchopulmonary Dysplasia (BPD) or death by 36 weeks of postmenstrual age in premature infants. Read more about this study
- Who is it for?
- Ages 14 to 28 days
- Conditions the study is for
- Infant, Premature, Bronchopulmonary Dysplasia (BPD)
- What is being tested?
- Dexamethasone. Dart and Dexametasone. Medium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 970 participants
- Where
- 24 sitesChina
- Study dates
- 1 Feb 2026to 31 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 14 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age 24+0 to 29+6 weeks; requires invasive mechanical ventilation for ≥14 days after birth; within 14-28 days of age at first receive of dexamethasone.
- FiO₂ > 40% and MAP > 8 cmH₂O (maintained for at least 24 hours prior to enrollment).
- Parent/Legal guardian has provided signed informed consent.
- No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria.
- Exclusion Criteria (Will be excluded if they meet ANY of the following)
- Presence of ventilator-associated pneumonia at the time of enrollment.
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- Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency.
- Suffering from other severe life-threatening illnesses with a short-expected survival time.
- Parent/Legal guardian refuses to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites
Chengdu Maternal and Children's Health Care Hospital
Chengdu
Rong Ju, 8618080103629, jurong123@126.com
Children's Hospital of Chongqing Medical University
Chongqing
Yuan Shi, 8613508300283, shiyuan@hospital.cqmu.edu.cn
Huan Wei
Women and Children's Hospital of Chongqing Medical University
Chongqing
Qian Xie, 8615340515641, 377048376@qq.com
Guangdong Women and Children Hospital
Guangdong
Chuan Nie, 8613682270294, chuannie@sina.com
Guangxi Maternal and Child Health Hospital
Guangxi
Yan Mo, 8615296545640, 76443688@qq.com
Guiyang Maternity and Child Health Care Hospital
Guiyang
Binzheng Shi, 8613595009325, gzsbz1972@aliyun.com
Guizhou Provincial People's Hospital
Guizhou
Rong Chen, 8618185119705, chenronggy@foxmail.com
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 0571
Zheng Chen, 0571-13857151000, chenz@zju.edu.cn
Zheng Chen
The First Hospital of Jilin University
Jilin City
Hui Wu, 8613134318877, wuhui@jlu.edu.cn
First Affiliated Hospital of Kunming Medical University
Kunming
Qinghua Zhong, 8613888340131, zqh114@126.com
Jiangxi Maternal and Child Health Hospital
Nanchang
Wenjun Zhou, 8613879187050, zwj200606@qq.com
Nanjing Maternity and Child Health Care Hospital
Nanjing
Xiaohui Chen, 8613851793158, chenxiaohui@njmu.edu.cn
Ningbo Women & Children's Hospital
Ningbo
Yanhong Li, 8615825558759, freesail2002@126.com
QuanZhou Women and Children's Hospital
Quanzhou
Qinjun Zhang, 8615160338150, 773168699@qq.com
Qujing Maternal and Child Health Hospital
Qujing
chuanfeng Li, 8613988970311, qjfyxselcf@163.com
Shanghai Children's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Chongbin Yan, 8613818648004, yancb@shchildren.com.cn
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Yongjun Zhang, 8613651736760, zhangyongjun@sjtu.edu.cn
Yongjun Zhang
Shengjing Hospital
Shengyang
Ana Hou, 8618940256568, sunnyhou_815@126.com
Shenzhen Maternal and Child Health Hospital
Shenzhen
Yongping Fu, 8615989868527, fypapple1234@163.com
Fourth Hospital of Shijiazhuang City
Shijiazhuang
Haiyan Ge, 8615833993362, gehaiyanhedy@126.com
Xiamen Women's and Children's Hospital
Xiamen
Zhi Zheng, 8613799748358, 1565950772@qq.com
First Affiliated Hospital of Xinjiang Medical University
Xinjiang
Ting Zhao, 8615809912084, lingxiao2029716@126.com
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou
Liping Xu, 8613607591899, zzsyxlp@163.com
Zhengzhou Children's Hospital, China
Zhengzhou
Wenqing Kang, 8613663862051, kwq_0608@163.com
About this study
Official title: The Outcomes of Different Dexamethasone Regimens for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants: A Multicenter Randomized Controlled Trial
The goal of this clinical trial is to compare the effectiveness of two different dexamethasone treatment regimens (the DART regimen and the medium-dose tapering regimen) in reducing the incidence of Bronchopulmonary Dysplasia (BPD) or death by 36 weeks of postmenstrual age in premature infants. This study will also assess the safety of these treatments. The main questions it aims to answer are: Does the DART regimen, compared to the medium-dose tapering regimen, lower the rate of BPD or BPD-related death by 36 weeks of postmenstrual age in eligible premature infants? How do the two regimens compare in terms of short-term respiratory outcomes (like time to come off the ventilator), complications at hospital discharge, and long-term neurodevelopmental outcomes at 18-24 months of corrected age?
Researchers will compare the DART regimen group (lower cumulative dose, given over 10 days) to the medium-dose tapering regimen group (higher cumulative dose, given over 7 days) to see which one is more effective and safer.
Read more
Participants will:
Inclusion Criteria (Must meet ALL of the following)
- Gestational age 24+0 to 29+6 weeks; requires invasive mechanical ventilation for ≥14 days after birth; within 14-28 days of age at first receive of dexamethasone.
- FiO₂ > 40% and MAP > 8 cmH₂O (maintained for at least 24 hours prior to enrollment).
- Parent/Legal guardian has provided signed informed consent.
- No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria.
- Exclusion Criteria (Will be excluded if they meet ANY of the following)
- Presence of ventilator-associated pneumonia at the time of enrollment.
- Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency.
- Suffering from other severe life-threatening illnesses with a short-expected survival time.
- Parent/Legal guardian refuses to participate in the study.
Read the detailed description
This study is a multicenter, prospective, randomized, parallel-controlled clinical trial.
Study Sites: Multiple hospitals across China with high-level Neonatal Intensive Care Units (NICUs) will participate.
Randomization:
A randomization method will be used to assign participants to one of two study groups in a 1:1 ratio. Subjects will receive a unique randomization number in the order of enrollment and will be assigned to one of the following treatment groups:
- DART regimen
- Moderate-dose tapering regimen
Blinding:
Blinding will be applied for the assessment of secondary outcomes (e.g., neurodevelopmental outcomes). Evaluators will be from an independent team and will not be involved in the routine clinical care of the infants.
- DART Regimen Group Cumulative dose: 0.89 mg/kg over 10 days Intravenous dexamethasone [17], administered as follows:
- 0.075 mg/kg/dose, every 12 hours for 3 days
- 0.05 mg/kg/dose, every 12 hours for 3 days
- 0.025 mg/kg/dose, every 12 hours for 2 days
- 0.01 mg/kg/dose, every 12 hours for 2 days, then discontinue If extubation is not successful more than or equal to two weeks after completing the treatment (FiO2 > 40% and MAP > 8 cmH2O), the DART regimen may be repeated. The number of repeated courses, reasons, and specific timing must be documented. (Note: According to reference [13], if the infant meets respiratory criteria again at least 72 hours after completing the initial 9-day course, a second 9-day course may be administered. If the infant meets the criteria again during the 42-day observation period, a third course may be considered.) Rationale for design: Due to the rapid physiological changes in preterm infants, early responses to interventions are often evident within short timeframes. The shorter assessment intervals aim to capture early treatment effects more sensitively and dynamically. Previous exploratory observations indicated that two-week intervals are feasible and safe for evaluating parameters such as weight gain and lab changes, with no significant adverse effects observed.
- Moderate-Dose Tapering Regimen Group
Cumulative dose: 2.35 mg/kg over 7 days Intravenous dexamethasone [19], administered as follows:
- 0.5 mg/kg/d for 3 days
- 0.25 mg/kg/d for 3 days
- 0.1 mg/kg/d for 1 day
If extubation is not successful more than or equal to two weeks after completing the treatment (FiO2 > 40% and MAP > 8 cmH2O), the same regimen may be repeated. The number of repeated courses, reasons, and specific timing must be documented.
Definition of BPD Severity (based on 2019 consensus criteria):
Clinically, BPD is defined as oxygen and/or respiratory support dependency for at least 28 days or continuing until 36 weeks corrected gestational age in preterm infants born at <32 weeks gestation.
- Being tested
- Dexamethasone. Dart, Dexametasone. Medium
- Medical subject headings
- Premature Birth, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone. DartDrug
DART regimen group (cumulative dose 0.89 mg/kg over 10 days): intravenous dexamethasone administered as follows:
0.075 mg/kg/dose every 12 hours for 3 days 0.05 mg/kg/dose every 12 hours for 3 days 0.025 mg/kg/dose every 12 hours for 2 days 0.01 mg/kg/dose every 12 hours for 2 days, then discontinue.
If extubation is not successful more than or equal to 2 weeks after completing the treatment, the regimen may be repeated.
Dexametasone. MediumDrug
Medium-dose tapering regimen group (cumulative dose 2.35 mg/kg over 7 days): intravenous dexamethasone administered as follows:
0.5 mg/kg/d for 3 days 0.25 mg/kg/d for 3 days 0.1 mg/kg/d for 1 day If extubation is not successful more than or equal to 2 weeks after completing the treatment, the regimen may be repeated.
| Study group | Role | What they receive |
|---|---|---|
| DART regimen | Experimental | DART regimen group (cumulative dose 0.89 mg/kg over 10 days) Receives: Drug: Dexamethasone. Dart |
| Medium-dose tapering regimen | Experimental | Medium-dose tapering regimen group (cumulative dose 2.35 mg/kg over 7 days) Receives: Drug: Dexametasone. Medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Bronchopulmonary dysplasia (BPD) and/or death at 36 weeks corrected age
Two different dexamethasone treatment regimens (DART regimen and moderate-dose tapering regimen) on the incidence of Bronchopulmonary dysplasia (BPD) and/or death at 36 weeks corrected age in preterm infants meeting inclusion criteria
BPD severity will be assessed at 36 weeks postmenstrual age (PMA) using the Jensen Criteria for BPD Severity, a categorical classification system. The Jensen Criteria define BPD severity based on the mode of respiratory support required at 36 weeks PMA:
Grade 0: No BPD (no respiratory support) Grade 1: Nasal cannula ≤2 L/min Grade 2: Nasal cannula >2 L/min or non-invasive positive airway pressure (e.g., continuous positive airway pressure (CPAP)), or noninvasive intermittent positive pressure ventilation (NIPPV) Grade 3: Invasive mechanical ventilation Higher grades represent worse outcomes (i.e., more severe BPD).
Measured: 36 weeks PMA
Secondary outcomes (10)
Extubation Rate (72 hours)
Weaning from the ventilator for more than 72 hours after the first course of dexamethasone
Measured: 72 hours
Extubation Rate (7 days)
Weaning from the ventilator for more than 7 days after the first course of dexamethasone.
Measured: 7 days
Incidence of Adverse Events Including Intestinal Perforation, Hyperglycemia, Hypertension, Infection, and Gastrointestinal Bleeding Following Dexamethasone Administration
Assessment of the number and type of adverse events related to dexamethasone administration, specifically monitoring for intestinal perforation, hyperglycemia, hypertension, infection, and gastrointestinal bleeding.
Measured: Within 72 hours and 7 days after dexamethasone administration
Oxygenation index
OI= (MAP × FiO₂ ×100 / PaO₂)
Measured: Baseline (Day 0) and on Days 3, 7, 10, 14, 28 Following Dexamethasone Therapy
Total Duration of Invasive Mechanical Ventilation During Initial Hospitalization
This outcome measures the cumulative number of days each participant receives invasive mechanical ventilation (via endotracheal tube) during the initial hospitalization from birth until discharge. This includes all consecutive and non-consecutive days on invasive respiratory support. The data will be reported in days.
Measured: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Total Length of Initial Hospitalization (Days from Birth to Discharge)
This outcome measures the total number of days each participant remains hospitalized from birth until initial hospital discharge. The duration is counted in calendar days, including any days spent in transfer between hospitals if part of the initial hospitalization period. The expected maximum timeframe is up to approximately 44 weeks PMA, depending on gestational age at birth.
Measured: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age )
Incidence of Neonatal Complications Including ROP, IVH, Hemodynamically Significant PDA, Late-Onset Sepsis, PVL, NEC, SIP, Short Bowel Syndrome, and Pulmonary Hypertension
This measure will capture the incidence of various neonatal complications occurring from birth until the time of hospital discharge. Complications include:
Retinopathy of Prematurity (ROP) Intraventricular Hemorrhage (IVH) Hemodynamically Significant Patent Ductus Arteriosus (HsPDA) Late-Onset Sepsis Periventricular Leukomalacia (PVL) Necrotizing Enterocolitis (NEC) Spontaneous Intestinal Perforation (SIP) Short Bowel Syndrome Pulmonary Hypertension Each diagnosis is based on clinical evaluation and/or standardized diagnostic criteria during the neonatal hospitalization period. The maximum follow-up duration is expected to be approximately 44 weeks PMA.
Measured: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) - Cognitive Composite Score (MDI)
The Bayley-III Cognitive Composite Score (formerly referred to as the Mental Development Index, MDI) assesses cognitive development.
Score Range: 55 (minimum) to 145 (maximum) Mean: 100 Standard Deviation: 15 Interpretation: Higher scores indicate better cognitive outcomes.
Measured: At 18 to 24 months corrected age
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) - Motor Composite Score (PDI)
The Bayley-III Motor Composite Score (formerly referred to as the Psychomotor Development Index, PDI) assesses fine and gross motor development.
Score range: 55 (minimum) to 145 (maximum) Mean: 100, Standard Deviation: 15 Higher scores indicate better motor outcomes
Measured: At 18 to 24 months corrected age
Griffiths Mental Development Scales - General Development Score
The Griffiths Mental Development Scales assess multiple developmental domains in infants and toddlers.
Score range: Typically 50 to 150 (depending on version) Mean: 100, Standard Deviation: 15 Higher scores indicate better developmental outcomes
Measured: At 18 to 24 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Feb 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 970 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Children's Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Yanping Xu, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052201
- Sponsor's protocol ID
- 2025-IRB-0185-P-02
- Status last verified
- Nov 2025
- First submitted
- 11 Jun 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After the article was published
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcomes of Different Dexamethasone Regimens for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07052201
- Acronym / sponsor ID
- 2025-IRB-0185-P-02
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 970 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 4 Jul 2025 (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 the effectiveness of two different dexamethasone treatment regimens (the DART regimen and the medium-dose tapering regimen) in reducing the incidence of Bronchopulmonary Dysplasia (BPD) or death by 36 weeks of postmenstrual age in premature infants. This study will also assess the safety of these treatments. The main questions it aims to answer are: Does the DART regimen, compared to the medium-dose tapering regimen, lower the rate of BPD or BPD-related death by 36 weeks of postmenstrual age in eligible premature infants? How do the two regimens compare in terms of short-term respiratory outcomes (like time to come off the ventilator), complications at hospital discharge, and long-term neurodevelopmental outcomes at 18-24 months of corrected age?
Researchers will compare the DART regimen group (lower cumulative dose, given over 10 days) to the medium-dose tapering regimen group (higher cumulative dose, given over 7 days) to see which one is more effective and safer.
Participants will:
Inclusion Criteria (Must meet ALL of the following)
- Gestational age 24+0 to 29+6 weeks; requires invasive mechanical ventilation for ≥14 days after birth; within 14-28 days of age at first receive of dexamethasone.
- FiO₂ > 40% and MAP > 8 cmH₂O (maintained for at least 24 hours prior to enrollment).
- Parent/Legal guardian has provided signed informed consent.
- No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria.
- Exclusion Criteria (Will be excluded if they meet ANY of the following)
- Presence of ventilator-associated pneumonia at the time of enrollment.
- Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency.
- Suffering from other severe life-threatening illnesses with a short-expected survival time.
- Parent/Legal guardian refuses to participate in the study.
Detailed description
This study is a multicenter, prospective, randomized, parallel-controlled clinical trial.
Study Sites: Multiple hospitals across China with high-level Neonatal Intensive Care Units (NICUs) will participate.
Randomization:
A randomization method will be used to assign participants to one of two study groups in a 1:1 ratio. Subjects will receive a unique randomization number in the order of enrollment and will be assigned to one of the following treatment groups:
- DART regimen
- Moderate-dose tapering regimen
Blinding:
Blinding will be applied for the assessment of secondary outcomes (e.g., neurodevelopmental outcomes). Evaluators will be from an independent team and will not be involved in the routine clinical care of the infants.
- DART Regimen Group Cumulative dose: 0.89 mg/kg over 10 days Intravenous dexamethasone [17], administered as follows:
- 0.075 mg/kg/dose, every 12 hours for 3 days
- 0.05 mg/kg/dose, every 12 hours for 3 days
- 0.025 mg/kg/dose, every 12 hours for 2 days
- 0.01 mg/kg/dose, every 12 hours for 2 days, then discontinue If extubation is not successful more than or equal to two weeks after completing the treatment (FiO2 > 40% and MAP > 8 cmH2O), the DART regimen may be repeated. The number of repeated courses, reasons, and specific timing must be documented. (Note: According to reference [13], if the infant meets respiratory criteria again at least 72 hours after completing the initial 9-day course, a second 9-day course may be administered. If the infant meets the criteria again during the 42-day observation period, a third course may be considered.) Rationale for design: Due to the rapid physiological changes in preterm infants, early responses to interventions are often evident within short timeframes. The shorter assessment intervals aim to capture early treatment effects more sensitively and dynamically. Previous exploratory observations indicated that two-week intervals are feasible and safe for evaluating parameters such as weight gain and lab changes, with no significant adverse effects observed.
- Moderate-Dose Tapering Regimen Group
Cumulative dose: 2.35 mg/kg over 7 days Intravenous dexamethasone [19], administered as follows:
- 0.5 mg/kg/d for 3 days
- 0.25 mg/kg/d for 3 days
- 0.1 mg/kg/d for 1 day
If extubation is not successful more than or equal to two weeks after completing the treatment (FiO2 > 40% and MAP > 8 cmH2O), the same regimen may be repeated. The number of repeated courses, reasons, and specific timing must be documented.
Definition of BPD Severity (based on 2019 consensus criteria):
Clinically, BPD is defined as oxygen and/or respiratory support dependency for at least 28 days or continuing until 36 weeks corrected gestational age in preterm infants born at <32 weeks gestation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DART regimen | Experimental | Drug: Dexamethasone. DartDART regimen group (cumulative dose 0.89 mg/kg over 10 days) |
| Medium-dose tapering regimen | Experimental | Drug: Dexametasone. MediumMedium-dose tapering regimen group (cumulative dose 2.35 mg/kg over 7 days) |
Who may qualify
- Ages
- 14 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Gestational age 24+0 to 29+6 weeks; requires invasive mechanical ventilation for ≥14 days after birth; within 14-28 days of age at first receive of dexamethasone.
- FiO₂ > 40% and MAP > 8 cmH₂O (maintained for at least 24 hours prior to enrollment).
- Parent/Legal guardian has provided signed informed consent.
- No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria.
- Exclusion Criteria (Will be excluded if they meet ANY of the following)
Key exclusion criteria (0 listed)
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. DartDART regimen group (cumulative dose 0.89 mg/kg over 10 days): intravenous dexamethasone administered as follows: 0.075 mg/kg/dose every 12 hours for 3 days 0.05 mg/kg/dose every 12 hours for 3 days 0.025 mg/kg/dose every 12 hours for 2 days 0.01 mg/kg/dose every 12 hours for 2 days, then discontinue. If extubation is not successful more than or equal to 2 weeks after completing the treatment, the regimen may be repeated. | Drug | DART regimen |
| Dexametasone. MediumMedium-dose tapering regimen group (cumulative dose 2.35 mg/kg over 7 days): intravenous dexamethasone administered as follows: 0.5 mg/kg/d for 3 days 0.25 mg/kg/d for 3 days 0.1 mg/kg/d for 1 day If extubation is not successful more than or equal to 2 weeks after completing the treatment, the regimen may be repeated. | Drug | Medium-dose tapering regimen |
Primary outcome
Incidence of Bronchopulmonary dysplasia (BPD) and/or death at 36 weeks corrected age
Time frame: 36 weeks PMA
Two different dexamethasone treatment regimens (DART regimen and moderate-dose tapering regimen) on the incidence of Bronchopulmonary dysplasia (BPD) and/or death at 36 weeks corrected age in preterm infants meeting inclusion criteria BPD severity will be assessed at 36 weeks postmenstrual age (PMA) using the Jensen Criteria for BPD Severity, a categorical classification system. The Jensen Criteria define BPD severity based on the mode of respiratory support required at 36 weeks PMA: Grade 0: No BPD (no respiratory support) Grade 1: Nasal cannula ≤2 L/min Grade 2: Nasal cannula >2 L/min or non-invasive positive airway pressure (e.g., continuous positive airway pressure (CPAP)), or noninvasive intermittent positive pressure ventilation (NIPPV) Grade 3: Invasive mechanical ventilation Higher grades represent worse outcomes (i.e., more severe BPD).
10 secondary outcomes
Extubation Rate (72 hours)
Time frame: 72 hours
Extubation Rate (7 days)
Time frame: 7 days
Incidence of Adverse Events Including Intestinal Perforation, Hyperglycemia, Hypertension, Infection, and Gastrointestinal Bleeding Following Dexamethasone Administration
Time frame: Within 72 hours and 7 days after dexamethasone administration
Oxygenation index
Time frame: Baseline (Day 0) and on Days 3, 7, 10, 14, 28 Following Dexamethasone Therapy
Total Duration of Invasive Mechanical Ventilation During Initial Hospitalization
Time frame: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Total Length of Initial Hospitalization (Days from Birth to Discharge)
Time frame: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age )
Incidence of Neonatal Complications Including ROP, IVH, Hemodynamically Significant PDA, Late-Onset Sepsis, PVL, NEC, SIP, Short Bowel Syndrome, and Pulmonary Hypertension
Time frame: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) - Cognitive Composite Score (MDI)
Time frame: At 18 to 24 months corrected age
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) - Motor Composite Score (PDI)
Time frame: At 18 to 24 months corrected age
Griffiths Mental Development Scales - General Development Score
Time frame: At 18 to 24 months corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided. After the article was published
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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.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone. Dart and Dexametasone. Medium in people with Infant, Premature and Bronchopulmonary Dysplasia (BPD), run by The Children's Hospital of Zhejiang University School of Medicine at 24 sites in China.
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 0 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: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Chen (8613857151000, chenz@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Bronchopulmonary dysplasia (BPD) and/or death at 36 weeks corrected age (time frame: 36 weeks PMA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2025.