Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT04725435
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2021-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Cerebral Oxygenation Results in Premature Infant
Sponsor:
Selcuk University
Organization:
Study Overview
Official Title:
Evaluation of Cerebral Oxygenation Results in Premature Infants: Kangaroo Care and Facilitated Tucking Example
Status:
COMPLETED
Status Verified Date:
2023-04
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:
The general purpose of this project is; Evaluation of cerebral oxygenation results in premature infants.
These results will be evaluated in two different applications. The first practice and the first sub-aim of the study is to determine the effect of kangaroo care on cerebral oxygenation (rSO2) in premature infants.
The second application and purpose is to determine the effect of giving the infant the facilitated tucking position by hand and the nesting bed on the cerebral oxygenation (rSO2) of the infant during the heel blood collection process.
The study will be conducted between December 2020 and December 2021 at Level III NICU at the Medical Faculty Hospital in Konya.
These results will be evaluated in two different applications. The first practice and the first sub-aim of the study is to determine the effect of kangaroo care on cerebral oxygenation (rSO2) in premature infants.
The second application and purpose is to determine the effect of giving the infant the facilitated tucking position by hand and the nesting bed on the cerebral oxygenation (rSO2) of the infant during the heel blood collection process.
The study will be conducted between December 2020 and December 2021 at Level III NICU at the Medical Faculty Hospital in Konya.
Detailed Description:
The general purpose of this project is; To determine the effect of kangaroo care and facilitated tucking position on cerebral oxygenation (rSO2) in premature infants.
In this context, the study has two sub-objectives. First sub purpose; to determine the effect of kangaroo care application given to premature inafants hospitalized in the NICU with the mother on cerebral oxygenation (rSO2), physiological parameters (heart rate, peripheral oxygen saturation (SpO2) and respiratory rate) and comfort / comfort levels.
This study was designed as a single blind, parallel group, pre-test and post-test randomized controlled trial.
First sub purpose; total sample size was determined as 40 preterm babies (20 in each group). Block randomization was used in this study. During the data collection phase, the purpose of the study will be explained to the parents of preterm infants by the researcher, and written consent will be obtained from the parents who agree to participate in the study through the "Informed Consent Form". Introductory Information Form, Physiological Parameter and rSO2 Follow-up Chart and Neonatal Comfort Scale created by the researcher will be used.
Second sub purpose; to determine the effect of facilitated tucking position on the infant's cerebral oxygenation (rSO2), physiological parameters (heart peak beat, SpO2 and respiratory rate), pain and comfort / comfort levels during the heel stick procedure.
This study was designed as a single blind, parallel group, two intervention groups in pre-test and post-test order, and a randomized controlled control group.
Second sub purpose; the total sample size was determined as 66 (22 in each group). Block randomization was used in this study. During the data collection phase, the purpose of the study will be explained to the parents of preterm infants by the researcher, and written consent will be obtained from the parents who agree to participate in the study through the "Informed Consent Form". The Introductory Information Form, Physiological Parameters and rSO2 Tracking Chart, PIPP-R and Neonatal Comfort Scale created by the researcher will be used.
In this context, the study has two sub-objectives. First sub purpose; to determine the effect of kangaroo care application given to premature inafants hospitalized in the NICU with the mother on cerebral oxygenation (rSO2), physiological parameters (heart rate, peripheral oxygen saturation (SpO2) and respiratory rate) and comfort / comfort levels.
This study was designed as a single blind, parallel group, pre-test and post-test randomized controlled trial.
First sub purpose; total sample size was determined as 40 preterm babies (20 in each group). Block randomization was used in this study. During the data collection phase, the purpose of the study will be explained to the parents of preterm infants by the researcher, and written consent will be obtained from the parents who agree to participate in the study through the "Informed Consent Form". Introductory Information Form, Physiological Parameter and rSO2 Follow-up Chart and Neonatal Comfort Scale created by the researcher will be used.
Second sub purpose; to determine the effect of facilitated tucking position on the infant's cerebral oxygenation (rSO2), physiological parameters (heart peak beat, SpO2 and respiratory rate), pain and comfort / comfort levels during the heel stick procedure.
This study was designed as a single blind, parallel group, two intervention groups in pre-test and post-test order, and a randomized controlled control group.
Second sub purpose; the total sample size was determined as 66 (22 in each group). Block randomization was used in this study. During the data collection phase, the purpose of the study will be explained to the parents of preterm infants by the researcher, and written consent will be obtained from the parents who agree to participate in the study through the "Informed Consent Form". The Introductory Information Form, Physiological Parameters and rSO2 Tracking Chart, PIPP-R and Neonatal Comfort Scale created by the researcher will be used.
Study Oversight
Has Oversight DMC:
False
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?: