Effect of Amniotic Fluid Odor on Newborn Adaptation and Stress (AFO-NAS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age38-42
SponsorAydin Adnan Menderes University
About this trial
This study aims to determine whether exposure to the odor of a newborn's own amniotic fluid affects postnatal adaptation and stress in healthy newborns born by cesarean section. Newborns will be randomly assigned to either an intervention group or a control group. Newborns in the intervention group will be exposed to a sterile material moistened with their own amniotic fluid, while newborns in the control group will be exposed to a sterile material moistened with distilled water. Postnatal adaptation, physiological responses, and stress levels will be evaluated at predetermined time points.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Newborns delivered by cesarean section at 38-42 weeks of gestation
Absence of a maternal history of high-risk pregnancy, including eclampsia, preeclampsia, or gestational diabetes
Disqualifiers
Birth weight below 2,500 g
Birth weight of 4,000 g or above
Apgar score below 7 at either 1 or 5 minutes after birth
Presence of a congenital anomaly
Trial design
Design model
Parallel
Treatments tested in this trial
Amniotic Fluid Odor Sterile Distilled Water Odor
Other interventionIn the intervention group, healthy newborns born by cesarean section will be exposed to the odor of their own amniotic fluid shortly after birth. Amniotic fluid collected during delivery will be applied to a sterile material and positioned near the newborn's nose without direct contact with the skin or airway. The intervention will be administered according to a standardized study protocol. The newborns' postnatal adaptation, physiological parameters, and stress responses will be assessed at predetermined time points.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Amniotic Fluid Odor GroupExperimental treatment 1 intervention
Group B: Distilled Water Odor ExposurePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Heart Rate:beats per minute
The newborn's heart rate will be measured using a pulse oximeter and recorded as beats per minute. Heart rate values will be compared between the amniotic fluid odor group and the sterile distilled water odor group.
Time frame
At 30 minutes after birth2
Respiratory Rate: breaths per minute
The newborn's respiratory rate will be assessed by counting respiratory movements for one minute and recorded as breaths per minute. Respiratory rate values will be compared between the study groups.
Time frame
At 30 minutes after birth3
Peripheral Oxygen Saturation:percentage
The newborn's peripheral oxygen saturation will be measured using a pulse oximeter and recorded as a percentage. Oxygen saturation values will be compared between the study groups.
Time frame
At 30 minutes after birth4
Body Temperature: degrees Celsius
The newborn's body temperature will be measured using a digital thermometer and recorded in degrees Celsius. Body temperature values will be compared between the study groups.
Time frame
At 30 minutes after birthSecondary outcomes
1
Neonatal Stress Level
Neonatal stress will be assessed using the Neonatal Stress Scale developed by Ceylan and Bolışık. The scale consists of eight subgroups: facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture. Each subgroup is scored from 0 to 2, resulting in a total score ranging from 0 to 16. A score of 0 indicates no stress, and higher scores indicate a higher level of neonatal stress and therefore a worse outcome.
Time frame
30 minutes after birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov