Babies Nourished by the Rhythm of Time: Maternal and Fetal Effects of Circadian Feeding and Reciprocal Scent Intervention in Neonatal Intensive Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Inonu University
- Enrollment
- 150
- Locations
- 1
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
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.
Eligibility Criteria
- Ages
- — to 1 Year (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
Esra SABANCI BARANSEL
Associate professor
Inonu University