Maternal Odor as a Developmental Care Intervention for Apnea of Prematurity (MOCARE)
PRETERM YENİDOĞANLARDA ANNE KOKUSUNUN APNE GELİŞİMİNE, FİZYOLOJİK PARAMETRELERE VE KİLO ALIMINA ETKİSİ
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Konya, 터키 (Türkiye), 06370
- Selcuk University Faculty of Medicine Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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간섭 없음: Control group
Preterm infants received routine neonatal intensive cate without maternal odor exposure
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of Apnea Episodes
기간: Daily for 5 consecutive days
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Number of apnea episodes experienced by preterm infants during the 5-day study period.
Apnea episodes were recorded prospectively using the Premature Observation Form.
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Daily for 5 consecutive days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Heart Rate
기간: Measured four times daily for 5 consecutive days
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Heart rate (beasts per minute) recorded during the study period and compared between the intervention and control groups
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Measured four times daily for 5 consecutive days
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Peripheral Oxygen Saturation
기간: Measured four times daily for 5 consecutive days
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Peripheral Oxygen Saturation (%) measured repeatedly during the study period and compared between the maternal odor and control groups.
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Measured four times daily for 5 consecutive days
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Respiratory Rate
기간: Measured four times daily for 5 consecutive days
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Respiratory rate (breaths per minute) recorded repeatedly during the study period and compared between the maternal odor and control groups.
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Measured four times daily for 5 consecutive days
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Body Temperature
기간: Measured four times daily for 5 consecutive days
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Body temperature recorded repeatedly during the study period and compared between the maternal odor and control groups.
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Measured four times daily for 5 consecutive days
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Weight Gain
기간: Baseline and Day 5
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Change in body weight (grams) from baseline to Day 5 and comparison between the maternal odor and control groups.
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Baseline and Day 5
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Head Circumference Growth
기간: Baseline and Day 5
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Change in head cincumference (cm) from baseline to Day 5 and comparison between the maternal odor and control groups.
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Baseline and Day 5
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EKIZILER-002
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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