Can a shorter steroid course save preemie lungs?
NCT ID NCT07052201
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two different ways of giving the steroid dexamethasone to very premature babies (born before 30 weeks) who have been on a breathing machine for at least two weeks. The goal is to see which treatment better prevents a serious lung condition called bronchopulmonary dysplasia (BPD) or death. About 970 babies will be randomly assigned to either a 10-day lower-dose regimen or a 7-day higher-dose regimen, and researchers will track their breathing progress and long-term development.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 970 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 to 28 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
24 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chengdu Maternal and Children's Health Care Hospital
Chengdu, China
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Children's Hospital of Chongqing Medical University
Chongqing, China
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Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 0571, China
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First Affiliated Hospital of Kunming Medical University
Kunming, China
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First Affiliated Hospital of Xinjiang Medical University
Xinjiang, China
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Fourth Hospital of Shijiazhuang City
Shijiazhuang, China
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Guangdong Women and Children Hospital
Guangdong, China
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Guangxi Maternal and Child Health Hospital
Guangxi, China
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Guiyang Maternity and Child Health Care Hospital
Guiyang, China
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Guizhou Provincial People's Hospital
Guizhou, China
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Jiangxi Maternal and Child Health Hospital
Nanchang, China
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Nanjing Maternity and Child Health Care Hospital
Nanjing, China
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Ningbo Women & Children's Hospital
Ningbo, China
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QuanZhou Women and Children's Hospital
Quanzhou, China
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Qujing Maternal and Child Health Hospital
Qujing, China
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Shanghai Children's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
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Shengjing Hospital
Shengyang, China
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Shenzhen Maternal and Child Health Hospital
Shenzhen, China
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The First Hospital of Jilin University
Jilin City, China
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Women and Children's Hospital of Chongqing Medical University
Chongqing, China
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Xiamen Women's and Children's Hospital
Xiamen, China
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
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Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, China
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Zhengzhou Children's Hospital, China
Zhengzhou, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could a simple blood test flag lung risk in preemies?
- Gentle touch and voice may ease stress for premature babies — a pilot trial puts it to the test
- Can a steroid shot into the windpipe protect preemies' lungs?
- Gentler resuscitation may protect fragile lungs in tiniest babies
- Nasal fentanyl spray could ease painful eye exams for premature babies
- Could cameras and microphones replace wires for premature babies?