Mechanical Ventilation, Prematurity
Conditions
Keywords
Premature Infant, Circadian Feeding, Reciprocal Scent, Breast Milk Production
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.
Interventions
BEHAVIORALReciprocal Scent Intervention
Maternal-infant reciprocal scent exposure combined with circadian-aligned feeding.
BEHAVIORALCircadian-Aligned Feeding
Breast milk feeding synchronized with the timing of milk expression according to circadian rhythm.
OTHERStandard Care (in control arm)
Standard Care
Sponsors
Inonu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ime to Weaning From Mechanical Ventilation | 21 days | Duration from initiation of mechanical ventilation to successful extubation without reintubation for at least 48 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Weight Gain | Baseline to Day 21 | Change in neonatal body weight measured daily during the intervention period. |
| Breast Milk Volume | Weekly during 21 days | Daily expressed breast milk volume produced by mothers during the intervention period. |
| Hydration Status (Diaper Weight) | Baseline to Day 21 | Neonatal hydration status assessed by diaper weight measurements during routine diaper changes. |
| Edinburgh Postnatal Depression Scale (EPDS) Score | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed