Dexamethasone Regimens for BPD Prevention in Preterm Infants
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age14-28
SponsorThe Children's Hospital of Zhejiang University School of Medicine
About this 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.
Participants will:
Inclusion Criteria (Must meet ALL of the following)
1. 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. 2. FiO₂ \> 40% and MAP \> 8 cmH₂O (maintained for at least 24 hours prior to enrollment). 3. Parent/Legal guardian has provided signed informed consent. 4. No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria.
2\. Exclusion Criteria (Will be excluded if they meet ANY of the following)
1. Presence of ventilator-associated pneumonia at the time of enrollment. 2. Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency. 3. Suffering from other severe life-threatening illnesses with a short-expected survival time. 4. Parent/Legal guardian refuses to participate in the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone. Dart
DrugDART 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. Medium
DrugMedium-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.
Treatment groups
970 Participants
are divided into 2 treatment groupsGroup A: DART regimenExperimental treatment 1 intervention
Group B: Medium-dose tapering regimenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
36 weeks PMASecondary outcomes
1
Extubation Rate (72 hours)
Weaning from the ventilator for more than 72 hours after the first course of dexamethasone
Time frame
72 hours2
Extubation Rate (7 days)
Weaning from the ventilator for more than 7 days after the first course of dexamethasone.
Time frame
7 days3
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.
Time frame
Within 72 hours and 7 days after dexamethasone administration4
Oxygenation index
OI= (MAP × FiO₂ ×100 / PaO₂)
Time frame
Baseline (Day 0) and on Days 3, 7, 10, 14, 28 Following Dexamethasone TherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
The Children's Hospital of Zhejiang University School of Medicine
Lead sponsor
Children's Hospital of Chongqing Medical University
Collaborator
Source ClinicalTrials.gov
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