PrematurityNCT07622459
Circadian Feeding and Reciprocal Scent Intervention in NICU
A study testing Reciprocal Scent Intervention and Circadian-Aligned Feeding in people with Prematurity and Mechanical Ventilation, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study evaluated the effects of circadian-aligned feeding and reciprocal scent intervention on premature infants receiving mechanical ventilation and on postpartum depression levels in their mothers. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Prematurity, Mechanical Ventilation
- What is being tested?
- Reciprocal Scent Intervention and Circadian-Aligned Feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Congenital anomalies or major malformations
- Genetic syndromes or severe systemic diseases
- Contraindications to breastfeeding (e.g., maternal HIV infection or cytotoxic drug use)
- Inability of mothers to participate in study procedures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sanliurfa Neonatal Intensive Care Unit
Sanliurfa
About this study
Official title: Babies Nourished by the Rhythm of Time: Maternal and Fetal Effects of Circadian Feeding and Reciprocal Scent Intervention in Neonatal Intensive Care
Objective: This study evaluated the effects of circadian-aligned feeding and reciprocal scent intervention on premature infants receiving mechanical ventilation and on postpartum depression levels in their mothers.
Methods: In this randomized controlled trial, 75 premature infants and their mothers were assigned to reciprocal scent, circadian feeding, or control groups (n=25 each). Interventions were applied for 21 days. Outcomes included time to weaning from mechanical ventilation, weight gain, hydration status, breast milk production, and maternal Edinburgh Postnatal Depression Scale (EPDS) scores.
Read the detailed description
This randomized controlled trial is designed to evaluate the effects of circadian-aligned feeding and reciprocal scent intervention, both alone and in combination, on clinical outcomes in premature infants receiving mechanical ventilation support and on postpartum depression levels in their mothers.
A total of 75 premature infants and their mothers will be enrolled and randomly assigned to one of three groups: a reciprocal scent intervention group, a circadian-aligned feeding group, or a control group (25 infant-mother dyads per group).
The interventions will be implemented for 21 days during the infants' hospitalization period. The primary outcome measure is time to weaning from mechanical ventilation. Secondary outcome measures include daily weight gain, hydration status assessed through diaper weight, daily breast milk production, and maternal postpartum depression assessed using the Edinburgh Postnatal Depression Scale (EPDS).
The study aims to determine whether these non-pharmacological interventions are associated with improvements in neonatal clinical outcomes and maternal psychological well-being.
- Conditions
- Prematurity, Mechanical Ventilation
- Being tested
- Reciprocal Scent Intervention, Circadian-Aligned Feeding, Standard Care (in control arm)
- Keywords
- Premature Infant, Circadian Feeding, Reciprocal Scent, Breast Milk Production
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reciprocal Scent InterventionBehavioural
Maternal-infant reciprocal scent exposure combined with circadian-aligned feeding.
Circadian-Aligned FeedingBehavioural
Breast milk feeding synchronized with the timing of milk expression according to circadian rhythm.
Standard Care (in control arm)Other
Standard Care
| Study group | Role | What they receive |
|---|---|---|
| Reciprocal Scent Group | Experimental | Participants received circadian-aligned feeding combined with reciprocal maternal-infant scent intervention for 21 days. Receives: Behavioral: Reciprocal Scent Intervention |
| Circadian Feeding Group | Experimental | Participants received circadian-aligned breast milk feeding based on milk expression timing for 21 days. Receives: Behavioral: Circadian-Aligned Feeding |
| Control Group | Other | Participants received standard neonatal intensive care without additional sensory or circadian intervention. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ime to Weaning From Mechanical Ventilation
Duration from initiation of mechanical ventilation to successful extubation without reintubation for at least 48 hours.
Measured: 21 days
Secondary outcomes (4)
Daily Weight Gain
Change in neonatal body weight measured daily during the intervention period.
Measured: Baseline to Day 21
Breast Milk Volume
Daily expressed breast milk volume produced by mothers during the intervention period.
Measured: Weekly during 21 days
Hydration Status (Diaper Weight)
Neonatal hydration status assessed by diaper weight measurements during routine diaper changes.
Measured: Baseline to Day 21
Edinburgh Postnatal Depression Scale (EPDS) Score
Maternal postpartum depression symptoms assessed using the Edinburgh Postnatal Depression Scale. Edinburgh Postnatal Depression Scale (EPDS) is a validated screening tool for postpartum depressive symptoms. The total score ranges from 0 to 30, with higher scores indicating more severe depressive symptoms and a worse outcome.
Measured: Baseline and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Oct 2025
- Primary completion1 Nov 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1:1 ratio to reciprocal scent intervention, circadian-aligned feeding, or standard care control groups. Interventions were applied in parallel for 21 days.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra SABANCI BARANSEL, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622459
- Sponsor's protocol ID
- 2025/8378
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available in order to protect participant confidentiality and privacy
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Babies Nourished by the Rhythm of Time: Maternal and Fetal Effects of Circadian Feeding and Reciprocal Scent Intervention in Neonatal Intensive Care
- ClinicalTrials.gov ID
- NCT07622459
- Acronym / sponsor ID
- 2025/8378
- Conditions
- Prematurity, Mechanical Ventilation
- Keywords
- Premature Infant, Circadian Feeding, Reciprocal Scent, Breast Milk Production
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 3 Jun 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.
Objective: This study evaluated the effects of circadian-aligned feeding and reciprocal scent intervention on premature infants receiving mechanical ventilation and on postpartum depression levels in their mothers.
Methods: In this randomized controlled trial, 75 premature infants and their mothers were assigned to reciprocal scent, circadian feeding, or control groups (n=25 each). Interventions were applied for 21 days. Outcomes included time to weaning from mechanical ventilation, weight gain, hydration status, breast milk production, and maternal Edinburgh Postnatal Depression Scale (EPDS) scores.
Detailed description
This randomized controlled trial is designed to evaluate the effects of circadian-aligned feeding and reciprocal scent intervention, both alone and in combination, on clinical outcomes in premature infants receiving mechanical ventilation support and on postpartum depression levels in their mothers.
A total of 75 premature infants and their mothers will be enrolled and randomly assigned to one of three groups: a reciprocal scent intervention group, a circadian-aligned feeding group, or a control group (25 infant-mother dyads per group).
The interventions will be implemented for 21 days during the infants' hospitalization period. The primary outcome measure is time to weaning from mechanical ventilation. Secondary outcome measures include daily weight gain, hydration status assessed through diaper weight, daily breast milk production, and maternal postpartum depression assessed using the Edinburgh Postnatal Depression Scale (EPDS).
The study aims to determine whether these non-pharmacological interventions are associated with improvements in neonatal clinical outcomes and maternal psychological well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants were randomly assigned in a 1:1:1 ratio to reciprocal scent intervention, circadian-aligned feeding, or standard care control groups. Interventions were applied in parallel for 21 days.
| Arm | Type | Receives |
|---|---|---|
| Reciprocal Scent Group | Experimental | Behavioral: Reciprocal Scent InterventionParticipants received circadian-aligned feeding combined with reciprocal maternal-infant scent intervention for 21 days. |
| Circadian Feeding Group | Experimental | Behavioral: Circadian-Aligned FeedingParticipants received circadian-aligned breast milk feeding based on milk expression timing for 21 days. |
| Control Group | Other | Other: Standard Care (in control arm)Participants received standard neonatal intensive care without additional sensory or circadian intervention. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Congenital anomalies or major malformations
- Genetic syndromes or severe systemic diseases
- Contraindications to breastfeeding (e.g., maternal HIV infection or cytotoxic drug use)
- Inability of mothers to participate in study procedures
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 |
|---|---|---|
| Reciprocal Scent InterventionMaternal-infant reciprocal scent exposure combined with circadian-aligned feeding. | Behavioural | Reciprocal Scent Group |
| Circadian-Aligned FeedingBreast milk feeding synchronized with the timing of milk expression according to circadian rhythm. | Behavioural | Circadian Feeding Group |
| Standard Care (in control arm)Standard Care | Other | Control Group |
Primary outcome
ime to Weaning From Mechanical Ventilation
Time frame: 21 days
Duration from initiation of mechanical ventilation to successful extubation without reintubation for at least 48 hours.
4 secondary outcomes
Daily Weight Gain
Time frame: Baseline to Day 21
Breast Milk Volume
Time frame: Weekly during 21 days
Hydration Status (Diaper Weight)
Time frame: Baseline to Day 21
Edinburgh Postnatal Depression Scale (EPDS) Score
Time frame: Baseline and Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available in order to protect participant confidentiality and privacy
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reciprocal Scent Intervention and Circadian-Aligned Feeding in people with Prematurity and Mechanical Ventilation, run by Inonu University at 1 site in Turkey (Türkiye).
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 0 inclusion and 4 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: finished, as of the sponsor's last update on 3 Jun 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ime to Weaning From Mechanical Ventilation (time frame: 21 days). 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 3 Jun 2026.