Apnea of PrematurityMOCARENCT07689669
Maternal Odor as a Developmental Care Intervention for Apnea of Prematurity
A study testing Maternal odor in people with Apnea of Prematurity and Prematurity, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 28 days
- Conditions the study is for
- Apnea of Prematurity, Prematurity
- What is being tested?
- Maternal odor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Faculty of Medicine Hospital
Konya, 06370
About this study
Official title: 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.
Read the 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.
- Conditions
- Apnea of Prematurity, Prematurity
- Being tested
- Maternal odor
- Keywords
- Maternal odor, Apnea of prematurity, Preterm infant, Developmental care, Neonatal intensive care, Physiologic stability, Randomized controlled trial
- Medical subject headings
- Apnea, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal odorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Maternal odor |
| Control group | No intervention | Preterm infants received routine neonatal intensive cate without maternal odor exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily for 5 consecutive days
Secondary outcomes (6)
Heart Rate
Heart rate (beasts per minute) recorded during the study period and compared between the intervention and control groups
Measured: 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: 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: 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: 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.
Measured: 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.
Measured: Baseline and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Nov 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea of PrematurityStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689669
- Sponsor's protocol ID
- EKIZILER-002
- Acronym
- MOCARE
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRETERM YENİDOĞANLARDA ANNE KOKUSUNUN APNE GELİŞİMİNE, FİZYOLOJİK PARAMETRELERE VE KİLO ALIMINA ETKİSİ
- ClinicalTrials.gov ID
- NCT07689669
- Acronym / sponsor ID
- MOCARE / EKIZILER-002
- Conditions
- Apnea of Prematurity, Prematurity
- Keywords
- Maternal odor, Apnea of prematurity, Preterm infant, Developmental care, Neonatal intensive care, Physiologic stability, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Maternal odor group | Experimental | Other: Maternal odorPreterm 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 |
Who may qualify
- Ages
- 5 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- Endotracheal intubation, mechanical ventilation, or nasal continuous positive airway pressure
- Receiving oxygen therapy
- Congenital heart disease
- Suspected or confirmed sepsis
- Intracranial hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal odorMaternal 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. | Other | Maternal odor group |
Primary outcome
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.
6 secondary outcomes
Heart Rate
Time frame: Measured four times daily for 5 consecutive days
Peripheral Oxygen Saturation
Time frame: Measured four times daily for 5 consecutive days
Respiratory Rate
Time frame: Measured four times daily for 5 consecutive days
Body Temperature
Time frame: Measured four times daily for 5 consecutive days
Weight Gain
Time frame: Baseline and Day 5
Head Circumference Growth
Time frame: Baseline and Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Apnea of Prematurity
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Neonatal Resuscitation, Apnea Neonatal
RecruitingObservational study
Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Premature Birth, Asthma in Children
Not yet recruitingObservational study
Automated Apnoea Detection in Preterms on Non-invasive Ventilation
Apnoea, Prematurity
Not yet recruiting
MICropsampling for CAffeine in PREMature Newborns
Apnea of Prematurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal odor in people with Apnea of Prematurity and Prematurity, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Apnea Episodes (time frame: Daily for 5 consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.