Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563973
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
The Effect of Breast Milk Odor on Feeeding in Preterm Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Breast Milk Odor Applied Before First Oral Feeding on Feeding Performance in Preterm Infants
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was conducted as a randomized controlled experiment to assess the impact of breast milk odor applied before the first oral feeding of preterm infants transitioning to oral feeding on their feeding performance Infants in the neonatal intensive care unit who were beginning oral feeding were randomly assigned to one of two groups through computer randomization In the pacifier group infants were given a pacifier for 3 minutes one hour before feeding and again for 2 minutes 10 minutes before feeding to support oral feeding In contrast the breast milk odor and pacifier group received 2 cc of breast milk which was dripped onto a sterile sponge and placed about 3 cm from the infants nose one hour before feeding At feeding time all infants in both groups were bottle-fed by the researcher This marked their first experience with oral feeding The infants feeding skills and performance were then evaluated using the Early Feeding Skills EFS form during the feeding session
Detailed Description:
Detailed Description
Recent research has indicated that olfactory stimulation can serve as an effective nonpharmacological method for enhancing feeding outcomes Using breast milk for olfactory stimulation is both a cost-efficient and noninvasive approach that may speed up the process of oral feeding and lead to better feeding results This study aimed to assess the impact of breast milk odor applied before the first oral feeding of preterm infants transitioning to oral feeding on their feeding performance The sample size was calculated using power analysis based on data from similar studies As per the analysis the study intended to include a total of 50 preterm infants with at least 25 infants in each group Following verbal and written consent from the families of eligible infants the study proceeded with those mothers and infants who agreed to participate
Before Feeding A pulse oximeter was attached to the feet of all infants to monitor their heart rate and oxygen saturation levels The researcher filled out the Preterm Infant Identification Form Nurses caring for the infants included in the study were briefed and care was provided for 60 minutes before feeding and 10 minutes after feeding to ensure the babies could rest No painful or stressful procedures were conducted during this period All interventions were carried out by the researcher in a quiet and calm environment within the incubator to minimize the impact of external factors Sixty minutes before feeding all infants were positioned in a semi-elevated side-lying position
Pacifier Group To support oral feeding a pacifier was provided for 3 minutes one hour before feeding time and again for 2 minutes 10 minutes before feeding Heart rate and oxygen saturation levels were recorded 10 minutes before feeding
Breast Milk Scent and Pacifier Group Similar to the pacifier group infants in this group received a pacifier for 3 minutes one hour before feeding and for 2 minutes 10 minutes before feeding Additionally 2 cc of breast milk was dripped onto a sterile sponge and placed inside the incubator approximately 3 cm from the infants nose Heart rate and oxygen saturation levels were also recorded 10 minutes before feeding
During Feeding
Once all pre-feeding procedures were completed and documented the infants position remained unchanged by the researcher The bottle was introduced near the infants mouth while they were in a semi-raised side-lying position The stopwatch was activated as soon as the infant began sucking To avoid tiring the infant feeding was limited to 30 minutes Throughout this period heart rate HR and oxygen saturation SpO2 were continuously monitored The infants feeding skills were assessed using the Early Feeding Skills EFS form by an observer nurse who was not involved in the study
A slow-flow soft nipple bottle with a smaller hole was used for feeding To encourage feeding the researcher gently touched the infants lips with the bottle nipple Once the infants mouth opened the nipple was placed inside carefully lowering the tongue During feeding any stimulating actions such as moving or rotating the bottle in the mouth were avoided
The infants were closely monitored for signs of fatigue eg reduced sucking milk leakage difficulty maintaining posture and symptoms of physiological or behavioral stress eg pulling the head back trying to turn away coughing grimacing aspiration desaturation apnea bradycardia tachycardia If any stress or fatigue signs were observed feeding was paused to allow the infant to rest Feeding resumed once the infant was physiologically stable HR 120-160min SpO2 90 and behaviorally ready
After Feeding
To avoid influencing physiological measurements no interventions were made for 10 minutes post-feeding The infants HR SpO2 values feeding duration and the amount of milk consumed during feeding were recorded on the data form
Recent research has indicated that olfactory stimulation can serve as an effective nonpharmacological method for enhancing feeding outcomes Using breast milk for olfactory stimulation is both a cost-efficient and noninvasive approach that may speed up the process of oral feeding and lead to better feeding results This study aimed to assess the impact of breast milk odor applied before the first oral feeding of preterm infants transitioning to oral feeding on their feeding performance The sample size was calculated using power analysis based on data from similar studies As per the analysis the study intended to include a total of 50 preterm infants with at least 25 infants in each group Following verbal and written consent from the families of eligible infants the study proceeded with those mothers and infants who agreed to participate
Before Feeding A pulse oximeter was attached to the feet of all infants to monitor their heart rate and oxygen saturation levels The researcher filled out the Preterm Infant Identification Form Nurses caring for the infants included in the study were briefed and care was provided for 60 minutes before feeding and 10 minutes after feeding to ensure the babies could rest No painful or stressful procedures were conducted during this period All interventions were carried out by the researcher in a quiet and calm environment within the incubator to minimize the impact of external factors Sixty minutes before feeding all infants were positioned in a semi-elevated side-lying position
Pacifier Group To support oral feeding a pacifier was provided for 3 minutes one hour before feeding time and again for 2 minutes 10 minutes before feeding Heart rate and oxygen saturation levels were recorded 10 minutes before feeding
Breast Milk Scent and Pacifier Group Similar to the pacifier group infants in this group received a pacifier for 3 minutes one hour before feeding and for 2 minutes 10 minutes before feeding Additionally 2 cc of breast milk was dripped onto a sterile sponge and placed inside the incubator approximately 3 cm from the infants nose Heart rate and oxygen saturation levels were also recorded 10 minutes before feeding
During Feeding
Once all pre-feeding procedures were completed and documented the infants position remained unchanged by the researcher The bottle was introduced near the infants mouth while they were in a semi-raised side-lying position The stopwatch was activated as soon as the infant began sucking To avoid tiring the infant feeding was limited to 30 minutes Throughout this period heart rate HR and oxygen saturation SpO2 were continuously monitored The infants feeding skills were assessed using the Early Feeding Skills EFS form by an observer nurse who was not involved in the study
A slow-flow soft nipple bottle with a smaller hole was used for feeding To encourage feeding the researcher gently touched the infants lips with the bottle nipple Once the infants mouth opened the nipple was placed inside carefully lowering the tongue During feeding any stimulating actions such as moving or rotating the bottle in the mouth were avoided
The infants were closely monitored for signs of fatigue eg reduced sucking milk leakage difficulty maintaining posture and symptoms of physiological or behavioral stress eg pulling the head back trying to turn away coughing grimacing aspiration desaturation apnea bradycardia tachycardia If any stress or fatigue signs were observed feeding was paused to allow the infant to rest Feeding resumed once the infant was physiologically stable HR 120-160min SpO2 90 and behaviorally ready
After Feeding
To avoid influencing physiological measurements no interventions were made for 10 minutes post-feeding The infants HR SpO2 values feeding duration and the amount of milk consumed during feeding were recorded on the data form
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None