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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reciprocal Scent Group | Experimental | Participants received circadian-aligned feeding combined with reciprocal maternal-infant scent intervention for 21 days. |
|
| Circadian Feeding Group | Experimental | Participants received circadian-aligned breast milk feeding based on milk expression timing for 21 days. |
|
| Control Group | Other | Participants received standard neonatal intensive care without additional sensory or circadian intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reciprocal Scent Intervention | Behavioral | Maternal-infant reciprocal scent exposure combined with circadian-aligned feeding. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ime to Weaning From Mechanical Ventilation | Duration from initiation of mechanical ventilation to successful extubation without reintubation for at least 48 hours. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Weight Gain | Change in neonatal body weight measured daily during the intervention period. | Baseline to Day 21 |
| Breast Milk Volume | Daily expressed breast milk volume produced by mothers during the intervention period. |
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Inclusion Criteria: Preterm neonates born before 37 weeks of gestation
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanliurfa Neonatal Intensive Care Unit | Sanliurfa | Turkey (Türkiye) |
Individual participant data will not be publicly available in order to protect participant confidentiality and privacy
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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.
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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.
| 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 |
|
| Weekly during 21 days |
| Hydration Status (Diaper Weight) | Neonatal hydration status assessed by diaper weight measurements during routine diaper changes. | Baseline to Day 21 |
| Edinburgh Postnatal Depression Scale (EPDS) Score | 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 |
| D000091642 | Urogenital Diseases |