Apnea of Prematurity, Prematurity
Conditions
Keywords
Maternal odor, Apnea of prematurity, Preterm infant, Developmental care, Neonatal intensive care, Physiologic stability, Randomized controlled trial
Brief summary
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.
Detailed description
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.
Interventions
OTHERMaternal odor
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.
Sponsors
Ankara Yildirim Beyazıt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blinding was not feasible because of the nature of the maternal odor intervention.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
5 Days to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Apnea Episodes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | 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 |
| Peripheral Oxygen Saturation | 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. |
| Respiratory Rate | 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. |
| Body Temperature | 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. |
| Weight Gain | Baseline and Day 5 | Change in body weight (grams) from baseline to Day 5 and comparison between the maternal odor and control groups. |
| Head Circumference Growth | Baseline and Day 5 | Change in head cincumference (cm) from baseline to Day 5 and comparison between the maternal odor and control groups. |
Countries
Turkey (Türkiye)
Outcome results
None listed