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New sleep program aims to improve health of preterm infants and reduce caregiver stress

NCT ID NCT04932044

Symptom relief Sponsor: National Defense Medical Center, Taiwan 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested an early sleep facilitation program for preterm infants and their caregivers. The program includes sleep training in the hospital and guidance for caregivers after discharge. Researchers measured infant sleep, health, and caregiver stress, sleep, quality of life, and attachment. The study involved 86 preterm infants and their main caregivers.

What this could mean

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

Active substance
Early Sleep Facilitation Program (behavioral intervention)
What this could lead to
If it works, this program could help preterm infants sleep better and improve their health, while also reducing stress and improving quality of life for their caregivers.
What could go wrong
This is a small, completed study with 86 participants, so results may not apply to all preterm infants. The program is behavioral, so effects may vary and are not a medical treatment.

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

86 people

The number who actually took part.

Started

Dec 2020

Finished

Nov 2023

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

28 to 37 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Preterm infants gestational age (GA) \> 28 weeks and \< 37 weeks, and birth weight less than 2200 grams; 2. The main caregiver of the preterm infants can communicate in Mandarin and Taiwanese; 3. The parents of the preterm infants and their main caregivers agrees to participate in this research and signs the research consent form Exclusion Criteria: 1. Premature infant is diagnosed with limb dysfunction or brain neuropathy, such as: third or fourth degree intraventricular hemorrhage or peripheral ventricular leukomalacia; 2. Other diseases that affect sleep, such as: congenital nerve development Abnormalities, epilepsy; 3. Those who need to take muscle relaxants, sedatives or bronchodilators

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Conditions

The condition(s) this trial relates to.

sleep disorder

As listed by the trial registrant

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

Preterm infants Quality of life Sleep

Contacts and locations

Locations

  • National defense medical center

    Taipei, Taiwan

More trials for these conditions

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