Maternal Odor as a Developmental Care Intervention for Apnea of Prematurity (MOCARE)

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

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.

Study Overview

• Status: Completed
• Conditions: Apnea of Prematurity; Prematurity
• Intervention / Treatment: Other: Maternal odor

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Konya, Turkey (Türkiye), 06370
    • Selcuk University Faculty of Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Maternal 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.
No Intervention: Control group; Preterm infants received routine neonatal intensive cate without maternal odor exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Developmental care; Preterm infant; Neonatal intensive care; Apnea of prematurity; Maternal odor; Physiologic stability
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Premature Birth; Apnea
• Other Study ID Numbers: EKIZILER-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No