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New study tests whether gentle care cuts hospital time for tiny newborns

NCT ID NCT06515574

Disease control Sponsor: Children's Hospital of Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a developmental care program for very low birth weight infants (under 1500 grams). The program includes controlling light, noise, and sleep, plus encouraging skin-to-skin contact. Researchers want to see if it shortens hospital stays and increases family involvement. The trial will involve 1600 babies across 40 neonatal intensive care units in China.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
developmental care (behavioural intervention: managing light, noise, sleep, and promoting skin-to-skin contact)
What this could lead to
If it works, this could help very low birth weight babies go home sooner and have more skin-to-skin contact with their parents.
What could go wrong
This is a large but early-stage implementation study; results may vary across hospitals, and the care bundle may not shorten hospital stays for all infants.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,600 people

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

Started

Aug 2024

Expected to finish

Dec 2027

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

0 to 30 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 1. Birth weights less than 1500 g 2. Admitted or transported to a level III NICU within 24h of birth 3. OI\>30 Exclusion Criteria: 1. Severe congenital malformations 2. various chromosomal disorders 3. genetic metabolic diseases, 4. severe neurological disorders

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intervention

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 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

  • Children's Hospital of Fudan University

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Children's hospital of Fudan university

    RECRUITING

    Shanghai, Shanghai / 上海, 201102, China

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