Infant Sleep ProblemsNCT07533578
Chrononutrition in Preterm Infants: a Randomised Controlled Trial of Time-matched Breast Milk Feeding and Its Effects on Sleep and Circadian Development
A study testing Chronobiologically Timed Feeding of Expressed Breast Milk and Usual Feeding Practice (Untimed Expressed Breast Milk) in people with Infant Sleep Problems and Circadian Rhythm, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
This study investigates whether the timing of feeding expressed breast milk influences infant sleep and circadian (day-night) development in preterm infants. In early life, infants produce very little of the hormone melatonin, which plays a key role in regulating sleep and circadian rhythms. Read more about this study
- Who is it for?
- Ages 0 days to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Infant Sleep Problems, Circadian Rhythm, Neurodevelopment
- What is being tested?
- Chronobiologically Timed Feeding of Expressed Breast Milk and Usual Feeding Practice (Untimed Expressed Breast Milk)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2026to 30 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants born between 32+0 and 36+6 weeks' gestation
- Age ≤ 1 month at enrolment
- Infants routinely receiving expressed breast milk (fully or partially breastfed)
- Written informed consent obtained from parent(s) or legal representative(s)
- Ability of caregivers to comply with study procedures including milk labelling and feeding according to study allocation
Who cannot join
- Prenatal exposure to illicit drugs (e.g. cannabis, cocaine, heroin, opiates) or significant alcohol exposure
- Major congenital malformations or congenital infections
- Significant underlying disease (excluding transient neonatal conditions such as feeding difficulties, hyperbilirubinaemia, hypoglycaemia, anaemia, respiratory distress syndrome, or apnoea-bradycardia syndrome)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study investigates whether the timing of feeding expressed breast milk influences infant sleep and circadian (day-night) development in preterm infants.
In early life, infants produce very little of the hormone melatonin, which plays a key role in regulating sleep and circadian rhythms. Breast milk naturally contains melatonin, and its levels vary across the day, with higher concentrations at night. This variation may provide important biological signals that help infants develop healthy sleep-wake patterns.
Read more
However, expressed breast milk is often fed without considering the time it was expressed. This may disrupt the transfer of circadian signals from mother to infant.
The aim of this randomised controlled trial is to determine whether feeding expressed breast milk according to the time of expression (e.g. giving night-time milk at night) improves sleep consolidation and circadian development compared with usual feeding practices.
A total of 200 preterm infants born between 32+0 and 36+6 weeks' gestation who are receiving expressed breast milk will be enrolled and randomly assigned to one of two groups:
Intervention group: preterm infants receive expressed breast milk matched to the time of day it was expressed (day, evening or night)
Control group: preterm infants receive expressed breast milk without regard to timing (usual practice)
The main outcome is sleep consolidation at 6 months of age, measured objectively using actigraphy (a small wearable device that records sleep and activity). Additional outcomes include sleep patterns over time, circadian development, melatonin exposure, gut microbiota composition, and clinical outcomes such as infections and neurodevelopment.
The intervention does not involve any medication and uses the infant's usual nutrition. Risks are minimal and mainly relate to the additional effort required for milk labelling and timing.
This study will provide evidence on whether a simple, low-risk change in feeding practice can support infant sleep and early-life circadian development, with potential benefits for child health and family well-being.
Read the detailed description
This study investigates whether the timing of feeding expressed breast milk influences infant sleep and circadian (day-night) development in preterm infants.
In early life, infants produce very little of the hormone melatonin, which plays a key role in regulating sleep and circadian rhythms. Breast milk naturally contains melatonin, and its levels vary across the day, with higher concentrations at night. This variation may provide important biological signals that help infants develop healthy sleep-wake patterns.
However, expressed breast milk is often fed without considering the time it was expressed. This may disrupt the transfer of circadian signals from mother to infant.
The aim of this randomised controlled trial is to determine whether feeding expressed breast milk according to the time of expression (e.g. giving night-time milk at night) improves sleep consolidation and circadian development compared with usual feeding practices.
A total of 200 preterm infants born between 32+0 and 36+6 weeks' gestation who are receiving expressed breast milk will be enrolled and randomly assigned to one of two groups:
Intervention group: preterm infants receive expressed breast milk matched to the time of day it was expressed (day, evening or night) Control group: preterm infants receive expressed breast milk without regard to timing (usual practice)
The main outcome is sleep consolidation at 6 months of age, measured objectively using actigraphy (a small wearable device that records sleep and activity). Additional outcomes include sleep patterns over time, circadian development, melatonin exposure, gut microbiota composition, and clinical outcomes such as infections and neurodevelopment.
The intervention does not involve any medication and uses the infant's usual nutrition. Risks are minimal and mainly relate to the additional effort required for milk labelling and timing.
This study will provide evidence on whether a simple, low-risk change in feeding practice can support infant sleep and early-life circadian development, with potential benefits for child health and family well-being.
- Conditions
- Infant Sleep Problems, Circadian Rhythm, Neurodevelopment
- Being tested
- Chronobiologically Timed Feeding of Expressed Breast Milk, Usual Feeding Practice (Untimed Expressed Breast Milk)
- Keywords
- Chrononutrition, Breast Milk, Circadian Rhythm, Circadian Development, Infant Sleep, Sleep Consolidation, Melatonin, Infant Microbiome, Gut Microbiota, Chronobiology, Sleep-Wake Cycle, Actigraphy, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronobiologically Timed Feeding of Expressed Breast MilkOther
Expressed breast milk is labelled at the time of expression and categorised into predefined time windows:
Day milk: 06:00-17:59 Evening milk: 18:00-21:59 Night milk: 22:00-05:59 Infants are fed milk corresponding to the appropriate time-of-day window to align feeding with circadian rhythms. Caregivers receive standardised training, and adherence is monitored using feeding logs.
Usual Feeding Practice (Untimed Expressed Breast Milk)Other
Expressed breast milk is fed without consideration of the time of expression. Milk handling, storage, and preparation follow standard procedures. No modification of milk composition or additional substances are introduced.
| Study group | Role | What they receive |
|---|---|---|
| Chronobiologically Timed Feeding of Expressed Breast Milk | Experimental | Infants receive expressed breast milk that is administered according to the time of expression (day, evening, or night), aligning feeding with circadian timing. Receives: Other: Chronobiologically Timed Feeding of Expressed Breast Milk |
| Usual Feeding Practice (Untimed Expressed Breast Milk) | Active comparator | Infants receive expressed breast milk without regard to the time of expression (standard care). Receives: Other: Usual Feeding Practice (Untimed Expressed Breast Milk) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep consolidation (longest nocturnal sleep bout)
Measured by actigraphy
Measured: At 6 months of age
Secondary outcomes (7)
Sleep fragmentation
Assessed by actigraphy and sleep-wake diaries
Measured: At 2, 4, 6, 12, and 24 months
Circadian rhythm development (day-night activity ratios and circadian function index)
Assessed by actigraphy
Measured: At 2, 4, 6, 12, and 24 months
Parent-reported sleep outcomes
Assessed using the Brief Infant Sleep Questionnaire (BISQ)
Measured: At 2, 4, 6, 12, and 24 months
Melatonin circadian profiles
In breast milk and infant stool
Measured: At 2, 4, 6, 12, and 24 months
Intestinal microbiota composition
Assessed by shotgun metagenomic sequencing
Measured: At 2, 4, 6, 12, and 24 months
Infection rates
Clinically diagnosed infections (including otitis media and lower respiratory tract infections), assessed via medical records and parental report
Measured: At 2, 4, 6, 12, and 24 months
Neurodevelopmental outcomes
Bayley Scales of Infant and Toddler Development (Bayley-III)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Sleep ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533578
- Sponsor's protocol ID
- 2026-
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised microbiome data will be made openly available in a recognised public repository (e.g. European Nucleotide Archive (ENA)).
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chrononutrition in Preterm Infants: a Randomised Controlled Trial of Time-matched Breast Milk Feeding and Its Effects on Sleep and Circadian Development
- ClinicalTrials.gov ID
- NCT07533578
- Acronym / sponsor ID
- 2026-
- Conditions
- Infant Sleep Problems, Circadian Rhythm, Neurodevelopment
- Keywords
- Chrononutrition, Breast Milk, Circadian Rhythm, Circadian Development, Infant Sleep, Sleep Consolidation, Melatonin, Infant Microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether the timing of feeding expressed breast milk influences infant sleep and circadian (day-night) development in preterm infants.
In early life, infants produce very little of the hormone melatonin, which plays a key role in regulating sleep and circadian rhythms. Breast milk naturally contains melatonin, and its levels vary across the day, with higher concentrations at night. This variation may provide important biological signals that help infants develop healthy sleep-wake patterns.
However, expressed breast milk is often fed without considering the time it was expressed. This may disrupt the transfer of circadian signals from mother to infant.
The aim of this randomised controlled trial is to determine whether feeding expressed breast milk according to the time of expression (e.g. giving night-time milk at night) improves sleep consolidation and circadian development compared with usual feeding practices.
A total of 200 preterm infants born between 32+0 and 36+6 weeks' gestation who are receiving expressed breast milk will be enrolled and randomly assigned to one of two groups:
Intervention group: preterm infants receive expressed breast milk matched to the time of day it was expressed (day, evening or night)
Control group: preterm infants receive expressed breast milk without regard to timing (usual practice)
The main outcome is sleep consolidation at 6 months of age, measured objectively using actigraphy (a small wearable device that records sleep and activity). Additional outcomes include sleep patterns over time, circadian development, melatonin exposure, gut microbiota composition, and clinical outcomes such as infections and neurodevelopment.
The intervention does not involve any medication and uses the infant's usual nutrition. Risks are minimal and mainly relate to the additional effort required for milk labelling and timing.
This study will provide evidence on whether a simple, low-risk change in feeding practice can support infant sleep and early-life circadian development, with potential benefits for child health and family well-being.
Detailed description
This study investigates whether the timing of feeding expressed breast milk influences infant sleep and circadian (day-night) development in preterm infants.
In early life, infants produce very little of the hormone melatonin, which plays a key role in regulating sleep and circadian rhythms. Breast milk naturally contains melatonin, and its levels vary across the day, with higher concentrations at night. This variation may provide important biological signals that help infants develop healthy sleep-wake patterns.
However, expressed breast milk is often fed without considering the time it was expressed. This may disrupt the transfer of circadian signals from mother to infant.
The aim of this randomised controlled trial is to determine whether feeding expressed breast milk according to the time of expression (e.g. giving night-time milk at night) improves sleep consolidation and circadian development compared with usual feeding practices.
A total of 200 preterm infants born between 32+0 and 36+6 weeks' gestation who are receiving expressed breast milk will be enrolled and randomly assigned to one of two groups:
Intervention group: preterm infants receive expressed breast milk matched to the time of day it was expressed (day, evening or night) Control group: preterm infants receive expressed breast milk without regard to timing (usual practice)
The main outcome is sleep consolidation at 6 months of age, measured objectively using actigraphy (a small wearable device that records sleep and activity). Additional outcomes include sleep patterns over time, circadian development, melatonin exposure, gut microbiota composition, and clinical outcomes such as infections and neurodevelopment.
The intervention does not involve any medication and uses the infant's usual nutrition. Risks are minimal and mainly relate to the additional effort required for milk labelling and timing.
This study will provide evidence on whether a simple, low-risk change in feeding practice can support infant sleep and early-life circadian development, with potential benefits for child health and family well-being.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronobiologically Timed Feeding of Expressed Breast Milk | Experimental | Other: Chronobiologically Timed Feeding of Expressed Breast MilkInfants receive expressed breast milk that is administered according to the time of expression (day, evening, or night), aligning feeding with circadian timing. |
| Usual Feeding Practice (Untimed Expressed Breast Milk) | Active comparator | Other: Usual Feeding Practice (Untimed Expressed Breast Milk)Infants receive expressed breast milk without regard to the time of expression (standard care). |
Who may qualify
- Ages
- 0 days to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm infants born between 32+0 and 36+6 weeks' gestation
- Age ≤ 1 month at enrolment
- Infants routinely receiving expressed breast milk (fully or partially breastfed)
- Written informed consent obtained from parent(s) or legal representative(s)
- Ability of caregivers to comply with study procedures including milk labelling and feeding according to study allocation
Key exclusion criteria (3 listed)
- Prenatal exposure to illicit drugs (e.g. cannabis, cocaine, heroin, opiates) or significant alcohol exposure
- Major congenital malformations or congenital infections
- Significant underlying disease (excluding transient neonatal conditions such as feeding difficulties, hyperbilirubinaemia, hypoglycaemia, anaemia, respiratory distress syndrome, or apnoea-bradycardia syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronobiologically Timed Feeding of Expressed Breast MilkExpressed breast milk is labelled at the time of expression and categorised into predefined time windows: Day milk: 06:00-17:59 Evening milk: 18:00-21:59 Night milk: 22:00-05:59 Infants are fed milk corresponding to the appropriate time-of-day window to align feeding with circadian rhythms. Caregivers receive standardised training, and adherence is monitored using feeding logs. | Other | Chronobiologically Timed Feeding of Expressed Breast Milk |
| Usual Feeding Practice (Untimed Expressed Breast Milk)Expressed breast milk is fed without consideration of the time of expression. Milk handling, storage, and preparation follow standard procedures. No modification of milk composition or additional substances are introduced. | Other | Usual Feeding Practice (Untimed Expressed Breast Milk) |
Primary outcome
Sleep consolidation (longest nocturnal sleep bout)
Time frame: At 6 months of age
Measured by actigraphy
7 secondary outcomes
Sleep fragmentation
Time frame: At 2, 4, 6, 12, and 24 months
Circadian rhythm development (day-night activity ratios and circadian function index)
Time frame: At 2, 4, 6, 12, and 24 months
Parent-reported sleep outcomes
Time frame: At 2, 4, 6, 12, and 24 months
Melatonin circadian profiles
Time frame: At 2, 4, 6, 12, and 24 months
Intestinal microbiota composition
Time frame: At 2, 4, 6, 12, and 24 months
Infection rates
Time frame: At 2, 4, 6, 12, and 24 months
Neurodevelopmental outcomes
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Yes. Anonymised microbiome data will be made openly available in a recognised public repository (e.g. European Nucleotide Archive (ENA)).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronobiologically Timed Feeding of Expressed Breast Milk and Usual Feeding Practice (Untimed Expressed Breast Milk) in people with Infant Sleep Problems and Circadian Rhythm, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Zimmermann, MD, PhD (+4141 205 82 69, petra.zimmermann@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep consolidation (longest nocturnal sleep bout) (time frame: At 6 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.