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

1. juli 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Ingen indgriben: Control group
Preterm infants received routine neonatal intensive cate without maternal odor exposure

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frequency of Apnea Episodes
Tidsramme: 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.
Daily for 5 consecutive days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Heart Rate
Tidsramme: 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
Measured four times daily for 5 consecutive days
Peripheral Oxygen Saturation
Tidsramme: 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.
Measured four times daily for 5 consecutive days
Respiratory Rate
Tidsramme: 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.
Measured four times daily for 5 consecutive days
Body Temperature
Tidsramme: 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.
Measured four times daily for 5 consecutive days
Weight Gain
Tidsramme: Baseline and Day 5
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
Tidsramme: Baseline and Day 5
Change in head cincumference (cm) from baseline to Day 5 and comparison between the maternal odor and control groups.
Baseline and Day 5

Samarbejdspartnere og efterforskere

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Sponsor

Ankara Yildirim Beyazıt University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2022

Primær færdiggørelse (Faktiske)

1. juni 2023

Studieafslutning (Faktiske)

1. juni 2023

Datoer for studieregistrering

Først indsendt

1. juli 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EKIZILER-002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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.

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