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Timing breast milk feeds may help preterm babies sleep better

NCT ID NCT07645677

Symptom relief Sponsor: Shanghai Jiao Tong University School of Medicine 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 09, 2026 · Updated 6 times

Summary

This study tests whether feeding preterm infants breast milk at the same time of day it was expressed can improve their sleep in the NICU. Researchers will compare this circadian-synchronized feeding approach to routine feeding in 120 preterm infants born between 28 and 36 weeks. Sleep patterns will be measured using a wearable EEG patch and sleep mat at 37 weeks corrected age.

What this could mean

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

Active substance
Circadian-synchronized breast milk feeding (behavioral intervention)
What this could lead to
If it works, this could offer a simple, drug-free way to improve sleep and help preterm infants develop healthier sleep patterns in the NICU.
What could go wrong
This is a small, early-stage trial with only 120 infants. The feeding approach may not significantly improve sleep, and results may not apply to all preterm 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 120 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 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 days and older

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: * Preterm infants born between 28 weeks and 36 weeks plus 6 days of gestation. * Infants who have reached full enteral feeding. * Written informed consent signed by a legal guardian. Exclusion Criteria: * Need for invasive respiratory support, such as endotracheal intubation. * Use of sedatives or other medications that may affect the central nervous system or sleep rhythm. * Presence of congenital neurologic or chromosomal abnormalities. * Presence of congenital gastrointestinal malformations or anorectal malformations. * Conditions affecting digestion or absorption, such as diarrhea, intestinal obstruction, or necrotizing enterocolitis. * Critical illnesses such as patent ductus arteriosus, neonatal sepsis, neutropenia, or coagulation disorders.

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Conditions

The condition(s) this trial relates to.

Premature Birth sleep disorder

As listed by the trial registrant

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

Preterm infant Sleep

How to take part

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

  1. The places running it

    6 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 Soochow University

    Shanghai, Jiangsu, 215025, China

  • Fujian Children's Hospital

    Fuzhou, Fujian, 350014, China

  • Nantong First People's Hospital

    Nantong, Jiangsu, 226001, China

  • Nantong Maternal and Child Health Hospital

    Nantong, Jiangsu, 226018, China

  • Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200127, China

  • Zhangjiagang First People's Hospital

    Zhangjiagang, Jiangsu, 215600, China

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