Dexamethasone Regimens for BPD Prevention in Preterm Infants

Not Applicable

Not yet recruiting

• Conditions: Infant, Premature; Bronchopulmonary Dysplasia (BPD)
• Interventions: Drug: Dexamethasone; Drug: Dexametasone

• Registration Number: NCT07052201
• Lead Sponsor: The Children's Hospital of Zhejiang University School of Medicine

Brief Summary

The goal of this clinical trial is to compare the effectiveness and safety of three different dexamethasone treatment regimens (DART regimen, low-dose tapering regimen, and medium-dose tapering regimen) in improving extubation success rates in preterm infants who require prolonged invasive mechanical ventilation. The main questions it aims to answer are:

What is the extubation success rate (defined as no reintubation within 72 hours and 7 days) after the first course of treatment in each group? How do the three regimens differ in terms of safety, including the incidence of short-term and long-term complications? Researchers will compare the DART regimen, low-dose tapering regimen, and medium-dose tapering regimen to see if any regimen leads to higher extubation success rates and fewer adverse outcomes.

Participants will:

Be randomized 1:1:1 to receive one of the three dexamethasone regimens via intravenous injection.

Receive standard respiratory and medical management in addition to the study drug.

Undergo regular assessments of oxygenation index (OI) at days 0, 3, 7, 10, 14, and 28 of treatment.

Be monitored for adverse events such as gastrointestinal bleeding, hyperglycemia, and hypertension.

Be followed until hospital discharge for outcomes including BPD severity, complications (e.g., ROP, IVH, NEC), and total duration of ventilation and hospitalization.

Undergo neurodevelopmental follow-up at 18-24 months corrected age using Bayley-III or Griffiths developmental scales.

Participants are preterm infants born between 24 and 29+6 weeks of gestation who require invasive ventilation for at least 8 days and meet strict oxygen and pressure criteria before enrollment. Infants with major congenital anomalies, immunodeficiencies, or life-threatening conditions will be excluded.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-26
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Posted: 2025-07-04
• Last Update Submitted: 2025-07-04
• Last Update Posted: 2025-07-09
• Primary Completion: 2028-01-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1212

Inclusion Criteria

• Gestational age between 24 weeks 0 days and 29 weeks 6 days
• Requires invasive mechanical ventilation for ≥8 days postnatally
• First dose of study medication administered between 8 and 28 days of life
• FiO₂ > 40% and Mean Airway Pressure (MAP) > 8 cmH₂O, maintained for at least 24 hours prior to enrollment
• Signed informed consent form from parent(s) or legal guardian(s)
• No prior use of systemic steroid medications before enrollment

Exclusion Criteria

• Presence of ventilator-associated pneumonia at the time of enrollment
• Presence of severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia)
• Known immunodeficiency
• Presence of other life-threatening conditions with limited life expectancy
• Parental or guardian refusal to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose tapering regimen	Dexamethasone	Low-dose tapering regimen group (cumulative dose 0.45 mg/kg over 3 days)
DART regimen	Dexamethasone	DART regimen group (cumulative dose 0.89 mg/kg over 10 days)
Medium-dose tapering regimen	Dexametasone	Medium-dose tapering regimen group (cumulative dose 2.35 mg/kg over 7 days)

Primary Outcome Measures

Name	Time	Method
Extubation Rate (72 hours)	72 hours	Weaning from the ventilator for more than 72 hours after the first course of dexamethasone
Extubation Rate (7 days)	7 days	Weaning from the ventilator for more than 7 days after the first course of dexamethasone.

Secondary Outcome Measures

Name	Time	Method
Oxygenation index	Baseline (Day 0) and on Days 3, 7, 10, 14, 28 Following Dexamethasone Therapy	OI= (MAP × FiO₂ ×100 / PaO₂)
Incidence of Adverse Events Including Intestinal Perforation, Hyperglycemia, Hypertension, Infection, and Gastrointestinal Bleeding Following Dexamethasone Administration	Within 72 hours and 7 days after 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.
Incidence and Severity of Bronchopulmonary Dysplasia (BPD) at 36 Weeks Postmenstrual Age (PMA), Classified Using the Jensen Criteria	36 weeks PMA	BPD severity will be assessed at 36 weeks 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., CPAP), or noninvasive intermittent positive pressure ventilation (NIPPV) Grade 3: Invasive mechanical ventilation Higher grades represent worse outcomes (i.e., more severe BPD).
Incidence of Neonatal Complications Including ROP, IVH, Hemodynamically Significant PDA, Late-Onset Sepsis, PVL, NEC, SIP, Short Bowel Syndrome, and Pulmonary Hypertension	From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)	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.
Total Duration of Invasive Mechanical Ventilation During Initial Hospitalization	From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)	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.
Total Length of Initial Hospitalization (Days from Birth to Discharge)	From birth until hospital discharge (up to approximately 44 weeks postmenstrual age )	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.
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) - Cognitive Composite Score (MDI)	At 18 to 24 months corrected age	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.
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) - Motor Composite Score (PDI)	At 18 to 24 months corrected age	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
Griffiths Mental Development Scales - General Development Score	At 18 to 24 months corrected age	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

Trial Locations

Locations (22)

Children's Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Chengdu Maternal and Children's Health Care Hospital; 🇨🇳 Chengdu, China

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China

Guangdong Women and Children Hospital; 🇨🇳 Guangdong, China

Guangxi Maternal and Child Health Hospital; 🇨🇳 Guangxi, China

Guiyang Maternity and Child Health Care Hospital; 🇨🇳 Guiyang, China

Guizhou Provincial People's Hospital; 🇨🇳 Guizhou, China

The First Hospital of Jilin University; 🇨🇳 Jilin, China

First Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, China

Jiangxi Maternal and Child Health Hospital; 🇨🇳 Nanchang, China

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