Maternal Odor as a Developmental Care Intervention for Apnea of Prematurity (MOCARE)
1. juli 2026 oppdatert av: Ankara Yildirim Beyazıt University
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Konya, Tyrkia (Türkiye), 06370
- Selcuk University Faculty of Medicine Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
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Ingen inngripen: Control group
Preterm infants received routine neonatal intensive cate without maternal odor exposure
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Frequency of Apnea Episodes
Tidsramme: Daily for 5 consecutive days
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Number of apnea episodes experienced by preterm infants during the 5-day study period.
Apnea episodes were recorded prospectively using the Premature Observation Form.
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Daily for 5 consecutive days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Heart Rate
Tidsramme: Measured four times daily for 5 consecutive days
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Heart rate (beasts per minute) recorded during the study period and compared between the intervention and control groups
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Measured four times daily for 5 consecutive days
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Peripheral Oxygen Saturation
Tidsramme: Measured four times daily for 5 consecutive days
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Peripheral Oxygen Saturation (%) measured repeatedly during the study period and compared between the maternal odor and control groups.
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Measured four times daily for 5 consecutive days
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Respiratory Rate
Tidsramme: Measured four times daily for 5 consecutive days
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Respiratory rate (breaths per minute) recorded repeatedly during the study period and compared between the maternal odor and control groups.
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Measured four times daily for 5 consecutive days
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Body Temperature
Tidsramme: Measured four times daily for 5 consecutive days
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Body temperature recorded repeatedly during the study period and compared between the maternal odor and control groups.
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Measured four times daily for 5 consecutive days
|
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Weight Gain
Tidsramme: Baseline and Day 5
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Change in body weight (grams) from baseline to Day 5 and comparison between the maternal odor and control groups.
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Baseline and Day 5
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Head Circumference Growth
Tidsramme: Baseline and Day 5
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Change in head cincumference (cm) from baseline to Day 5 and comparison between the maternal odor and control groups.
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Baseline and Day 5
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Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
1. november 2022
Primær fullføring (Faktiske)
1. juni 2023
Studiet fullført (Faktiske)
1. juni 2023
Datoer for studieregistrering
Først innsendt
1. juli 2026
Først innsendt som oppfylte QC-kriteriene
1. juli 2026
Først lagt ut (Faktiske)
8. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juli 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Obstetrisk arbeid, prematur
- Obstetriske arbeidskomplikasjoner
- Graviditetskomplikasjoner
- Sykdommer i luftveiene
- Respirasjonsforstyrrelser
- Tegn og symptomer, luftveier
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- For tidlig fødsel
- Apné
Andre studie-ID-numre
- EKIZILER-002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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Nei
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