Effect of Intranasal Breast Milk Administration in Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-37
SponsorSelcuk University
About this trial
The aim of the study was to investigate the effect of intranasal breast milk administration on cerebral oxygenation level, vital signs and time to full oral feeding in preterm infants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Birth weight >1000 gr,
APGAR score >7 at 5 minutes after birth,
Availability of breast milk,
No medical diagnosis affecting cerebral oxygenation (intraventricular hemorrhage, cardiovascular and neurological disorders, anemia),
Disqualifiers
Being able to feed orally in all feedings
Being fed entirely on formula milk,
Administration of medication via the nasal route,
Being intubated or receiving continuous positive air pressure (CPAP) support,
Trial design
Design model
Parallel
Treatments tested in this trial
Intranasal human breast milk
Other interventionThe information in the "Physiologic Parameter Follow-up Form" will be recorded by the investigator just 5 minutes before the intervention. The researcher will drip 0.2 ml of breast milk at room temperature (approximately 22 °C) into the nose of the infant lying in the supine position, 0.1 ml in the right nose-0.1 ml in the left nose. 5 minutes after the intervention (T1), 15 minutes after the intervention (T2) and 30 minutes after the intervention (T3), the data in the "Physiologic Parameter Follow-up Form" will be recorded by the researcher. After intranasal breast milk administration, the baby will be fed by the neonatal nurse as in routine practice. The implementation of the intervention in the study will last for three days and this process will be repeated three times every day (09.00, 12.00 and 15.00).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Intranasal Breast Milk GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Infant Information Form
The form developed by the researchers in line with the literature includes the identifying information of the preterm infant (gender, date of birth, gestational week at birth, mode of delivery, APGAR score, birth weight, postmenstrual age)
Time frame
First measurement-First day of hospitalization2
Physiologic Parameter Follow-up Form-Cerebral rSO2
Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Time frame
First measurement- 5 minutes before the intervention (T0)3
Physiologic Parameter Follow-up Form-Oxygen saturation (sPO2)
Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Time frame
First measurement- 5 minutes before the intervention (T0)4
Physiologic Parameter Follow-up Form-Heart Rate (HR)
Heart rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Time frame
First measurement- 5 minutes before the intervention (T0)Secondary outcomes
1
Physiologic Parameter Follow-up Form -Cerebral rSO2
Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.
Time frame
Second measurement- 5. minutes after the intervention (T1)2
Physiologic Parameter Follow-up Form -Cerebral rSO2
Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.
Time frame
Second measurement- 15. minutes after the intervention (T1)3
Physiologic Parameter Follow-up Form -Cerebral rSO2
Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.
Time frame
Second measurement- 30. minutes after the intervention (T1)4
Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)
Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.
Time frame
Second measurement- 5. minutes after the intervention (T1)Sponsors and contacts
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Source ClinicalTrials.gov