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NCT Number: NCT07689669

Maternal Odor as a Developmental Care Intervention for Apnea of Prematurity

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.

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Key information

Conditions

Apnea of Prematurity Apnea Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Prematurity Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Age range

5 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University Faculty of Medicine Hospital

Konya, 06370, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Frequency of Apnea Episodes

    Time frame: 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 outcomes

  1. Heart Rate

    Time frame: 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

  2. Peripheral Oxygen Saturation

    Time frame: 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.

  3. Respiratory Rate

    Time frame: 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.

  4. Body Temperature

    Time frame: 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.

  5. Weight Gain

    Time frame: Baseline and Day 5

    Change in body weight (grams) from baseline to Day 5 and comparison between the maternal odor and control groups.

  6. Head Circumference Growth

    Time frame: Baseline and Day 5

    Change in head cincumference (cm) from baseline to Day 5 and comparison between the maternal odor and control groups.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

PRETERM YENİDOĞANLARDA ANNE KOKUSUNUN APNE GELİŞİMİNE, FİZYOLOJİK PARAMETRELERE VE KİLO ALIMINA ETKİSİ

Acronym: MOCARE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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