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Completed

NCT Number: NCT07622459

Circadian Feeding and Reciprocal Scent Intervention in NICU

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.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Mechanical Ventilation Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanliurfa Neonatal Intensive Care Unit

Sanliurfa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reciprocal Scent Intervention

Behavioral

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

Circadian-Aligned Feeding

Behavioral

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

Standard Care (in control arm)

Other

Standard Care

Primary outcomes

  1. 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.

Secondary outcomes

  1. Daily Weight Gain

    Time frame: Baseline to Day 21

    Change in neonatal body weight measured daily during the intervention period.

  2. Breast Milk Volume

    Time frame: Weekly during 21 days

    Daily expressed breast milk volume produced by mothers during the intervention period.

  3. Hydration Status (Diaper Weight)

    Time frame: Baseline to Day 21

    Neonatal hydration status assessed by diaper weight measurements during routine diaper changes.

  4. 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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

Babies Nourished by the Rhythm of Time: Maternal and Fetal Effects of Circadian Feeding and Reciprocal Scent Intervention in Neonatal Intensive Care

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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