Circadian Feeding and Reciprocal Scent Intervention in NICU

NCT07622459 | Completed DMC

• 1 other identifier: 2025/8378
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prematurity; Mechanical Ventilation

Keywords

Premature Infant; Circadian Feeding; Reciprocal Scent; Breast Milk Production

Outcome Measures

Primary Outcomes (1)

• ime to Weaning From Mechanical Ventilation

  Duration from initiation of mechanical ventilation to successful extubation without reintubation for at least 48 hours.

  21 days

Secondary Outcomes (4)

• Daily Weight Gain

  Baseline to Day 21

• Breast Milk Volume

  Weekly during 21 days

• Hydration Status (Diaper Weight)

  Baseline to Day 21

• Edinburgh Postnatal Depression Scale (EPDS) Score

  Baseline and Day 21

Study Arms (3)

Reciprocal Scent Group

EXPERIMENTAL

Participants received circadian-aligned feeding combined with reciprocal maternal-infant scent intervention for 21 days.

Behavioral: Reciprocal Scent Intervention

Circadian Feeding Group

EXPERIMENTAL

Participants received circadian-aligned breast milk feeding based on milk expression timing for 21 days.

Behavioral: Circadian-Aligned Feeding

Control Group

OTHER

Participants received standard neonatal intensive care without additional sensory or circadian intervention.

Other: Standard Care (in control arm)

Interventions

Reciprocal Scent Intervention BEHAVIORAL

Maternal-infant reciprocal scent exposure combined with circadian-aligned feeding.

Reciprocal Scent Group

Circadian-Aligned Feeding BEHAVIORAL

Breast milk feeding synchronized with the timing of milk expression according to circadian rhythm.

Circadian Feeding Group

Standard Care (in control arm) OTHER

Standard Care

Control Group

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Sanliurfa Neonatal Intensive Care Unit

Sanliurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Due to the nature of the interventions, mothers and investigators could not be blinded. Premature infants were considered participant-blinded because they were unaware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 3, 2026
• Study Start: October 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: April 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)