Circadian Feeding and Reciprocal Scent Intervention in NICU
Babies Nourished by the Rhythm of Time: Maternal and Fetal Effects of Circadian Feeding and Reciprocal Scent Intervention in Neonatal Intensive Care
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Sanliurfa、トルコ（Türkiye）
- Sanliurfa Neonatal Intensive Care Unit
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Reciprocal Scent Group
Participants received circadian-aligned feeding combined with reciprocal maternal-infant scent intervention for 21 days.
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Maternal-infant reciprocal scent exposure combined with circadian-aligned feeding.
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実験的：Circadian Feeding Group
Participants received circadian-aligned breast milk feeding based on milk expression timing for 21 days.
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Breast milk feeding synchronized with the timing of milk expression according to circadian rhythm.
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|
他の：Control Group
Participants received standard neonatal intensive care without additional sensory or circadian intervention.
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標準治療
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ime to Weaning From Mechanical Ventilation
時間枠：21 days
|
Duration from initiation of mechanical ventilation to successful extubation without reintubation for at least 48 hours.
|
21 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Daily Weight Gain
時間枠：Baseline to Day 21
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Change in neonatal body weight measured daily during the intervention period.
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Baseline to Day 21
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Breast Milk Volume
時間枠：Weekly during 21 days
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Daily expressed breast milk volume produced by mothers during the intervention period.
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Weekly during 21 days
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Hydration Status (Diaper Weight)
時間枠：Baseline to Day 21
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Neonatal hydration status assessed by diaper weight measurements during routine diaper changes.
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Baseline to Day 21
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Edinburgh Postnatal Depression Scale (EPDS) Score
時間枠：Baseline and Day 21
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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.
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Baseline and Day 21
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2025/8378
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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