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Can a shorter steroid course save preemie lungs?

NCT ID NCT07052201

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 970 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

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

14 to 28 days

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Chengdu Maternal and Children's Health Care Hospital

    Chengdu, China

  • Children's Hospital of Chongqing Medical University

    Chongqing, China

  • Children's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 0571, China

  • First Affiliated Hospital of Kunming Medical University

    Kunming, China

  • First Affiliated Hospital of Xinjiang Medical University

    Xinjiang, China

  • Fourth Hospital of Shijiazhuang City

    Shijiazhuang, 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

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, China

  • Nanjing Maternity and Child Health Care Hospital

    Nanjing, China

  • Ningbo Women & Children's Hospital

    Ningbo, China

  • QuanZhou Women and Children's Hospital

    Quanzhou, China

  • Qujing Maternal and Child Health Hospital

    Qujing, China

  • Shanghai Children's Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, China

  • Shengjing Hospital

    Shengyang, China

  • Shenzhen Maternal and Child Health Hospital

    Shenzhen, China

  • The First Hospital of Jilin University

    Jilin City, China

  • Women and Children's Hospital of Chongqing Medical University

    Chongqing, China

  • Xiamen Women's and Children's Hospital

    Xiamen, China

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, China

  • Zhangzhou Affiliated Hospital of Fujian Medical University

    Zhangzhou, China

  • Zhengzhou Children's Hospital, China

    Zhengzhou, China

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Other studies related to the condition(s) this trial covers.