Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean Section
Conditions
Brief summary
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.
Interventions
OTHERAmniotic Fluid Odor Sterile Distilled Water Odor
In 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.
Sponsors
Aydin Adnan Menderes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
38 Weeks to 42 Weeks
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * Admission to the neonatal intensive care unit during the early postnatal period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate:beats per minute | At 30 minutes after birth | 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. |
| Respiratory Rate: breaths per minute | At 30 minutes after birth | 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. |
| Peripheral Oxygen Saturation:percentage | At 30 minutes after birth | 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. |
| Body Temperature: degrees Celsius | At 30 minutes after birth | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Stress Level | 30 minutes after birth | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTfunda güler, pHd
STUDY_CHAIRzekiye karaçam, prof
Aydin Adnan Menderes University
Outcome results
None listed