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Apnea of prematurity is one of the most common complications in preterm infants hospitalized in neonatal intensive care units. This randomized controlled trial was conducted to evaluate the effect of maternal odor exposure as a developmental care intervention on apnea frequency, physiological parameters, and growth outcomes in preterm infants. Sixty preterm infants were randomly assigned to either a maternal odor intervention group or a routine care control group. The intervention group received maternal odor using a cotton cloth carrying the mother's natural scent for five consecutive days. The primary outcome was the daily number of apnea episodes. Secondary outcomes included oxygen saturation, heart rate, respiratory rate, body temperature, weight, and head circumference.
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 (SpOâ‚‚), 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maternal odor group | Experimental | 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. |
|
| Control group | No Intervention | Preterm infants received routine neonatal intensive cate without maternal odor exposure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maternal odor | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Apnea Episodes | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Selcuk University Faculty of Medicine Hospital | Konya | 06370 | Turkey (Türkiye) |
Individual participant data will not be made publicly available. The informed consent obtained from participants' parents/legal guardians did not include permission for sharing individual participant data with external researchers.
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| ID | Term |
|---|---|
| D001049 | Apnea |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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Participants were randomly assigned 1:1 ratio to either a maternal odor intervention group or a routine care control group. The intervention group received maternal odor exposure for five consecutive days, while the control group received routine neonatal intensive care.
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Blinding was not feasible because of the nature of the maternal odor intervention.
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|
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 | 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 | 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 | 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 | Change in head cincumference (cm) from baseline to Day 5 and comparison between the maternal odor and control groups. | Baseline and Day 5 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |