Maternal Odor as a Developmental Care Intervention for Apnea of Prematurity (MOCARE)
PRETERM YENİDOĞANLARDA ANNE KOKUSUNUN APNE GELİŞİMİNE, FİZYOLOJİK PARAMETRELERE VE KİLO ALIMINA ETKİSİ
調査の概要
詳細な説明
Apnea of prematurity is a frequent complication of preterm birth and is associated with intermittent hypoxemia and adverse clinical outcomes. Developmental care interventions that provide familiar sensory stimulation may improve physiological stability in preterm infants. Maternal odor is a natural olfactory stimulus that may support autonomic regulation and respiratory stability through early sensory recognition.
This single-center, parallel-group, randomized controlled trial evaluated the effectiveness of maternal odor exposure in preterm infants admitted to the neonatal intensive care unit. Sixty eligible preterm infants were randomly assigned in a 1:1 ratio to either a maternal odor intervention group or a routine care control group. Maternal odor was provided using a cotton cloth impregnated with the mother's natural body odor, positioned approximately 10-15 cm from the infant's head for five consecutive days and replaced every 8 hours.
The primary outcome was the daily frequency of apnea episodes. Secondary outcomes included oxygen saturation (SpO₂), heart rate, respiratory rate, body temperature, weight, and head circumference. Outcomes were compared between groups to determine whether maternal odor exposure improves respiratory stability and physiological regulation in preterm infants.
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
-
-
-
Konya、トルコ（Türkiye）、06370
- Selcuk University Faculty of Medicine Hospital
-
-
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 infants born between 26 and 37 weeks of gestation
- Birth weight between 1000 and 2500 g
- Hospitalized in the neonatal intensive care unit for at least 5 days
- Receiving oral or enteral feeding
- Written informed consent obtained from parent(s) or legal guardian(s)
Exclusion Criteria:
- Endotracheal intubation, mechanical ventilation, or nasal continuous positive airway pressure
- Receiving oxygen therapy
- Congenital heart disease
- Suspected or confirmed sepsis
- Intracranial hemorrhage
- Receiving analgesic, sedative, or muscle relaxant therapy
- Previous surgical procedure
- Development of a medical condition requiring withdrawal from the study or hospitalization for less than 5 days
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Maternal odor group
Preterm infants received maternal odor exposure using a cotton cloth carrying the mother's natural body odor placed 10-15 cm from the infant's head for five consecutive days in addition to routine neonatal intensive care.
|
Maternal odor exposure was provided using a cotton cloth carrying the mother's natural body odor.
The cloth was placed approximately 10-15 cm from the infant's head during routine care for five consecutive days.
The cloth was replaced every 8 hours to maintain the maternal odor.
|
|
介入なし：Control group
Preterm infants received routine neonatal intensive cate without maternal odor exposure
|
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 |
|---|---|---|
|
Frequency of Apnea Episodes
時間枠：Daily for 5 consecutive days
|
Number of apnea episodes experienced by preterm infants during the 5-day study period.
Apnea episodes were recorded prospectively using the Premature Observation Form.
|
Daily for 5 consecutive days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Heart Rate
時間枠：Measured four times daily for 5 consecutive days
|
Heart rate (beasts per minute) recorded during the study period and compared between the intervention and control groups
|
Measured four times daily for 5 consecutive days
|
|
Peripheral Oxygen Saturation
時間枠：Measured four times daily for 5 consecutive days
|
Peripheral Oxygen Saturation (%) measured repeatedly during the study period and compared between the maternal odor and control groups.
|
Measured four times daily for 5 consecutive days
|
|
Respiratory Rate
時間枠：Measured four times daily for 5 consecutive days
|
Respiratory rate (breaths per minute) recorded repeatedly during the study period and compared between the maternal odor and control groups.
|
Measured four times daily for 5 consecutive days
|
|
Body Temperature
時間枠：Measured four times daily for 5 consecutive days
|
Body temperature recorded repeatedly during the study period and compared between the maternal odor and control groups.
|
Measured four times daily for 5 consecutive days
|
|
Weight Gain
時間枠：Baseline and Day 5
|
Change in body weight (grams) from baseline to Day 5 and comparison between the maternal odor and control groups.
|
Baseline and Day 5
|
|
Head Circumference Growth
時間枠：Baseline and Day 5
|
Change in head cincumference (cm) from baseline to Day 5 and comparison between the maternal odor and control groups.
|
Baseline and Day 5
|
協力者と研究者
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
- EKIZILER-002
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。