Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380231
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2024-03-09
Brief Title:
Skin-to-skin Contact Between Premature Infant and Mother
Sponsor:
Istanbul Rumeli University
Organization:
Istanbul Rumeli University
Study Overview
Official Title:
a Randomized Controlled Experimental Design That Uses a Pretest-Posttest Control Group Model
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim To determine the effect of kangaroo mother care KMC on perfusion index heart rate and oxygen saturation in premature infants who were discharged early and admitted to the neonatal intensive care in the following days
Detailed Description:
METHOD Design This study has a randomized controlled experimental design and uses a pretest-posttest control group model Consolidated Standards of Reporting Trials CONSORT guidelines were followed throughout the study protocol
Experimental n 38 and control n 38 groups were assigned using the simple randomization technique at the neonatal intensive care unit NICU of private an university hospital in Istanbul Turkey Heart rate perfusion index and oxygen saturation levels of the experimental group in which KMC was applied and the control group in which KMC was not applied were compared Data were collected via the Mother and Infant Introductory Information Form Kangaroo Mother Care Preparation Checklist Kangaroo-Mother Care- Physiological Parameter Monitoring Form and Noninvasive Pulse Co-Oximetry
Setting The study was conducted on premature infants receiving incubator care in the NICU of a private university hospital in Istanbul Turkey There are 15 nurses one of whom is the charge nurse one neonatologist three assistant doctors five auxiliary staff members and one secretary working in the NICU The research nurse in this study also worked in the NICU where the study was conducted
The NICU has a bed capacity of 10 and15 and contains 20 incubators with monitors six mechanical ventilators nine vital monitoring devices one isolation one milk and formula preparation one medication preparation and one lactation station There is a special section in the breastfeeding room reserved for KMC with a fully equipped incubator and monitor The KMC room has a chair an incubator and a monitor which have noninvasive pulse co-oximetry NIS-pulse co-oximeter
KMC is a doctors order for babies hospitalized in NICU and is applied routinely If you dont mind the doctor recommends KMC to all babies twice a day It was only applied once a day during the Coronavirus-19 pandemic period
Data Collection Tools In this study three forms and noninvasive pulse co-oximetry MR NI-pulse co-oximeter were used to collect data Mother and Baby Identification Information Form MIIF includes the mothers age social security smoking and alcohol history and history gender birth birth cycle positive ventilation status postnatal APGAR score gestational age and weight This form was prepared from patient files and literature information
The Kangaroo Mother Care Preparation Checklist KMCPC is a list of mother and babys preparation for KMC The form includes information such as clothing hygiene position duration temperature protection for mother and baby and was developed in accordance with the literature
Kangaroo-Mother Care-Physiological Parameter Monitoring Form KMC-PPMF is a form in which information about the babys perfusion index heart rate and premature oxygen saturation is recorded during before and after the KMC KMC-PPMF is a form prepared and used by the Research and Application Hospital Quality Unit and the Cronbach alpha value of the form is 0777 good level
MR NIS-pulse co-oximeter has been used in all intensive care units in recent years MR NIS-pulse co-oximeter have a spectrophotometric sensor that may be an adhesive single use for continuous monitoring or a reusable finger clip sensor for spot check assessments It has been reported that noninvasive hemoglobin Hb monitoring with pulse CO-oximetry may be useful in the early detection of Hb changes in newborns MR noninvasive spectrophotometric NIS-pulse co-oximeter is a noninvasive monitoring device featuring pulse oximetry with the option to measure multiple additional parameters such as perfusion index heart rate and oxygen saturation total hemoglobin respiration rate
Mother-Infant Preparation and KMC The KMC is a separate section with an incubator inside the breastfeeding room in the NICU The space was kept at a temperature of 24 and 26C was private and had no air circulation and little noise or light The room contained a clean hospital shirt for mothers to wear when they removed their top clothes and a seat where they could sit comfortably with their infants To minimize fluctuations in KMC biorhythms measurements were recorded at the same time every 24-hour for both the experimental and control groups
All mothers were instructed to take a bath before coming to the hospital and not to wear perfume body cream accessories or makeup
Experimental Group The purpose of the study was explained to the mothers of the experimental group infants selected for the study by the researcher nurse written informed consent was obtained KMC was explained and demonstrated to the mothers and an illustrated NICU brochure was given to them for review The easiest part of this research was that the vast majority of mothers were knowledgeable about KMC because it was already practiced in the NICU The mothers only requested additional details about information related to wearing jewelry perfume or lotion
On the day of KMC the experimental group mother was taken to the KMC room her upper garment was removed and a clean front-opening hospital shirt was put on The hands abdomen and breasts of the mothers were cleaned with 04 chlorhexidine and the mothers were seated in the KMC chair All infants were fed and their diapers changed one hour before being handed over to their mothers The mothers were made to warm their hands by rubbing them before holding the infant in their hands
The Control Group The control group dont received KMC
Statistical Analysis To examine the distribution of the data skewness and kurtosis values were examined with the Shapiro-Wilk-Kolmogorov-Smirnov test p0005 According to the Kolmogorov-Smirnov test the data were normally or nearly normally distributed between -22 p0005 While Pearson correlation coefficient r was used to analyze the relationships between normal data frequency and percentage N and mean and standard deviation Mean SD Chi-square test χ2 Fisher exact test and independent sample t-test were used in the analysis of qualitative and quantitative variable data The Statistical Package for Social Sciences version 220 software IBM Corp Armonk New York USA was used The p-values lower than 005 were considered statistically significant
The data on the physiological parameters perfusion index heart rate and oxygen saturation of experimental and control group babies were in vivo measurements The deviations of these data from the arithmetic mean were shown as mean and standard deviation Statistics of these data were performed with the independent sample t-test Pearsons chi-square test was used to determine the relationship between categorical data such as mode of delivery status of receiving positive pressure ventilation and reason for NICU admission were analysed using Since the expected values related to mode of delivery and gender were low Fishers Exact test was used
Random Block Scheme Although the homogeneity of the groups was tried to be preserved in the study with sampling criteria and unbiased assignment the similarity and effects of the variables cannot be guaranteed In this case the random block order was important The block design could be applied to the control group After collecting the data of the control group babies the researcher performed KMC on these babies upon the doctors request within two hours and recorded the physiological parameters Under these conditions the effect of KMC was similar in both the experimental and the control group where the random block was applied and the difference was statistically insignificant Significance values of 0 15 th 30 th and 45 th minutes regarding perfusion index peak heart rate and oxygen saturation of the experimental and control groups in a random block scheme Equal variances assumed p 0328 p 0058 p 0132 for 0 th minutes p 094 p 0091 p 0292 for 15 th minutes p 0064 p 0108 p 0060 for 30 th minutes p 0066 p 0202 p 0245 for 45 th minutes The experimental and control groups are homogeneous and have similar results during KMC
Experimental n 38 and control n 38 groups were assigned using the simple randomization technique at the neonatal intensive care unit NICU of private an university hospital in Istanbul Turkey Heart rate perfusion index and oxygen saturation levels of the experimental group in which KMC was applied and the control group in which KMC was not applied were compared Data were collected via the Mother and Infant Introductory Information Form Kangaroo Mother Care Preparation Checklist Kangaroo-Mother Care- Physiological Parameter Monitoring Form and Noninvasive Pulse Co-Oximetry
Setting The study was conducted on premature infants receiving incubator care in the NICU of a private university hospital in Istanbul Turkey There are 15 nurses one of whom is the charge nurse one neonatologist three assistant doctors five auxiliary staff members and one secretary working in the NICU The research nurse in this study also worked in the NICU where the study was conducted
The NICU has a bed capacity of 10 and15 and contains 20 incubators with monitors six mechanical ventilators nine vital monitoring devices one isolation one milk and formula preparation one medication preparation and one lactation station There is a special section in the breastfeeding room reserved for KMC with a fully equipped incubator and monitor The KMC room has a chair an incubator and a monitor which have noninvasive pulse co-oximetry NIS-pulse co-oximeter
KMC is a doctors order for babies hospitalized in NICU and is applied routinely If you dont mind the doctor recommends KMC to all babies twice a day It was only applied once a day during the Coronavirus-19 pandemic period
Data Collection Tools In this study three forms and noninvasive pulse co-oximetry MR NI-pulse co-oximeter were used to collect data Mother and Baby Identification Information Form MIIF includes the mothers age social security smoking and alcohol history and history gender birth birth cycle positive ventilation status postnatal APGAR score gestational age and weight This form was prepared from patient files and literature information
The Kangaroo Mother Care Preparation Checklist KMCPC is a list of mother and babys preparation for KMC The form includes information such as clothing hygiene position duration temperature protection for mother and baby and was developed in accordance with the literature
Kangaroo-Mother Care-Physiological Parameter Monitoring Form KMC-PPMF is a form in which information about the babys perfusion index heart rate and premature oxygen saturation is recorded during before and after the KMC KMC-PPMF is a form prepared and used by the Research and Application Hospital Quality Unit and the Cronbach alpha value of the form is 0777 good level
MR NIS-pulse co-oximeter has been used in all intensive care units in recent years MR NIS-pulse co-oximeter have a spectrophotometric sensor that may be an adhesive single use for continuous monitoring or a reusable finger clip sensor for spot check assessments It has been reported that noninvasive hemoglobin Hb monitoring with pulse CO-oximetry may be useful in the early detection of Hb changes in newborns MR noninvasive spectrophotometric NIS-pulse co-oximeter is a noninvasive monitoring device featuring pulse oximetry with the option to measure multiple additional parameters such as perfusion index heart rate and oxygen saturation total hemoglobin respiration rate
Mother-Infant Preparation and KMC The KMC is a separate section with an incubator inside the breastfeeding room in the NICU The space was kept at a temperature of 24 and 26C was private and had no air circulation and little noise or light The room contained a clean hospital shirt for mothers to wear when they removed their top clothes and a seat where they could sit comfortably with their infants To minimize fluctuations in KMC biorhythms measurements were recorded at the same time every 24-hour for both the experimental and control groups
All mothers were instructed to take a bath before coming to the hospital and not to wear perfume body cream accessories or makeup
Experimental Group The purpose of the study was explained to the mothers of the experimental group infants selected for the study by the researcher nurse written informed consent was obtained KMC was explained and demonstrated to the mothers and an illustrated NICU brochure was given to them for review The easiest part of this research was that the vast majority of mothers were knowledgeable about KMC because it was already practiced in the NICU The mothers only requested additional details about information related to wearing jewelry perfume or lotion
On the day of KMC the experimental group mother was taken to the KMC room her upper garment was removed and a clean front-opening hospital shirt was put on The hands abdomen and breasts of the mothers were cleaned with 04 chlorhexidine and the mothers were seated in the KMC chair All infants were fed and their diapers changed one hour before being handed over to their mothers The mothers were made to warm their hands by rubbing them before holding the infant in their hands
The Control Group The control group dont received KMC
Statistical Analysis To examine the distribution of the data skewness and kurtosis values were examined with the Shapiro-Wilk-Kolmogorov-Smirnov test p0005 According to the Kolmogorov-Smirnov test the data were normally or nearly normally distributed between -22 p0005 While Pearson correlation coefficient r was used to analyze the relationships between normal data frequency and percentage N and mean and standard deviation Mean SD Chi-square test χ2 Fisher exact test and independent sample t-test were used in the analysis of qualitative and quantitative variable data The Statistical Package for Social Sciences version 220 software IBM Corp Armonk New York USA was used The p-values lower than 005 were considered statistically significant
The data on the physiological parameters perfusion index heart rate and oxygen saturation of experimental and control group babies were in vivo measurements The deviations of these data from the arithmetic mean were shown as mean and standard deviation Statistics of these data were performed with the independent sample t-test Pearsons chi-square test was used to determine the relationship between categorical data such as mode of delivery status of receiving positive pressure ventilation and reason for NICU admission were analysed using Since the expected values related to mode of delivery and gender were low Fishers Exact test was used
Random Block Scheme Although the homogeneity of the groups was tried to be preserved in the study with sampling criteria and unbiased assignment the similarity and effects of the variables cannot be guaranteed In this case the random block order was important The block design could be applied to the control group After collecting the data of the control group babies the researcher performed KMC on these babies upon the doctors request within two hours and recorded the physiological parameters Under these conditions the effect of KMC was similar in both the experimental and the control group where the random block was applied and the difference was statistically insignificant Significance values of 0 15 th 30 th and 45 th minutes regarding perfusion index peak heart rate and oxygen saturation of the experimental and control groups in a random block scheme Equal variances assumed p 0328 p 0058 p 0132 for 0 th minutes p 094 p 0091 p 0292 for 15 th minutes p 0064 p 0108 p 0060 for 30 th minutes p 0066 p 0202 p 0245 for 45 th minutes The experimental and control groups are homogeneous and have similar results during KMC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None