Circadian Feeding and Reciprocal Scent Intervention in NICU

June 2, 2026 updated by: Esra SABANCI BARANSEL, Inonu University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Sanliurfa, Turkey (Türkiye)
        • Sanliurfa Neonatal Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Preterm neonates born before 37 weeks of gestation

  • Intubated neonates requiring mechanical ventilation support
  • Within the first 24 hours after birth
  • Receiving enteral feeding
  • Mothers willing to participate in the study

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reciprocal Scent Group
Participants received circadian-aligned feeding combined with reciprocal maternal-infant scent intervention for 21 days.
Behavioral: Reciprocal Scent Intervention
Maternal-infant reciprocal scent exposure combined with circadian-aligned feeding.
Experimental: Circadian Feeding Group
Participants received circadian-aligned breast milk feeding based on milk expression timing for 21 days.
Behavioral: Circadian-Aligned Feeding
Breast milk feeding synchronized with the timing of milk expression according to circadian rhythm.
Other: Control Group
Participants received standard neonatal intensive care without additional sensory or circadian intervention.
Other: Standard Care (in control arm)
Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Weight Gain
Time Frame: Baseline to Day 21
Change in neonatal body weight measured daily during the intervention period.
Baseline to Day 21
Breast Milk Volume
Time Frame: Weekly during 21 days
Daily expressed breast milk volume produced by mothers during the intervention period.
Weekly during 21 days
Hydration Status (Diaper Weight)
Time Frame: Baseline to Day 21
Neonatal hydration status assessed by diaper weight measurements during routine diaper changes.
Baseline to Day 21
Edinburgh Postnatal Depression Scale (EPDS) Score
Time Frame: Baseline and Day 21
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.
Baseline and Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/8378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly available in order to protect participant confidentiality and privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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