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NICU study: does more time with parents help preterm babies thrive?

NCT ID NCT04761419

Knowledge-focused Sponsor: Nagano Children's Hospital Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 90 premature babies born at 34 weeks or earlier in a Japanese NICU. Researchers track how much time parents spend with their infants, including skin-to-skin contact and care participation. The goal is to see if more parent presence lowers depression risk, improves bonding, shortens hospital stays, and boosts growth and development. No treatment is given—this is purely observational.

What this could mean

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

What this could lead to
If the findings show clear benefits, hospitals may adopt policies that encourage parents to spend more time with their premature babies in the NICU.
What could go wrong
This is an observational study, not a controlled experiment. It cannot prove cause and effect, and results may not apply to other hospitals or countries.

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.

Participants

90 people

The number who actually took part.

Started

Feb 2021

Expected to finish

Nov 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.

Who is studied

A level IV NICU in Japan

Ages

Up to 7 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: * Born at 34 weeks of gestation or earlier in Nagano Children's Hospital and need admission into NICU in the same hospital Exclusion Criteria: * Having any major anomalies including suspicion of chromosomal disorder on admission * At least one parent is Not Japanese * The consent is not obtained by day 7 * Do not survive until discharge home

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As listed by the trial registrant

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

Family-centered care

Contacts and locations

Locations

  • Nagano Children's Hospital

    Azumino, Nagano, 399-8288, Japan

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