Maternal Odor as a Developmental Care Intervention for Apnea of Prematurity

NCT07689669 | Completed

• 1 other identifier: EKIZILER-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity; Apnea of Prematurity

Keywords

Maternal odor; Apnea of prematurity; Preterm infant; Developmental care; Neonatal intensive care; Physiologic stability; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Heart Rate

  Measured four times daily for 5 consecutive days

• Peripheral Oxygen Saturation

  Measured four times daily for 5 consecutive days

• Respiratory Rate

  Measured four times daily for 5 consecutive days

• Body Temperature

  Measured four times daily for 5 consecutive days

• Weight Gain

  Baseline and Day 5

Study Arms (2)

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.

Other: Maternal odor

Control group

NO INTERVENTION

Preterm infants received routine neonatal intensive cate without maternal odor exposure

Interventions

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.

Maternal odor group

Eligibility Criteria

• Age: 5 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Selcuk University Faculty of Medicine Hospital

Konya, 06370, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Apnea; Premature Birth

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding was not feasible because of the nature of the maternal odor intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: November 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)