Clinical trial NCT04725435: Evaluation of Cerebral Oxygenation Results in Premature Infant
Official title: Evaluation of Cerebral Oxygenation Results in Premature Infants: Kangaroo Care and Facilitated Tucking Example
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Oxygenation
Premature
Kangaroo Care
Facilitated Tucking
Keywords: cerebral oxygenation
premature
kangaroo care
facilitated tucking
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2021-01-26
Enrollment: 106
Sex: ALL
Minimum age (years): 24
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: First sub purpose was designed as a single blind, parallel group, randomized controlled pre-test post-test order.

Second sub purpose was designed as a single blind, parallel group, two intervention groups in pre-test and post-test order, and a randomized controlled control group.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Adjusted gestational age of 28-36(+6) weeks at time of registration

Exclusion Criteria:

* Mechanical ventilation,
* Major congenital abnormalities,
* Surgical or severe medical morbidity (bronchopulmonary dysplasia, NEC, sepsis, or intraventricular bleeding)
* The mother is under 18 years of age
* The mother is not willing to do kangaroo care

Primary outcomes:
measure: The first sub-purpose Outcome: rSO2 level
timeFrame: Change from baseline and 70 min
measure: The first sub-purpose Outcome: physiological parameters of the premature infant- heart rate (min).
timeFrame: Change from baseline and 70 min
measure: The first sub-purpose Outcome: physiological parameters of the premature infant- SpO2 level
timeFrame: Change from baseline and 70 min
measure: The first sub-purpose Outcome: Neonates COMFORTneo scale
timeFrame: Change from baseline and 70 min
measure: The first sub-purpose Outcome: physiological parameters of the premature infant-respiratory rate (min)
timeFrame: Change from baseline and 70 min
Secondary outcomes:
measure: The second sub-purpose Outcome: Premature Infant Pain Profile Scale-Revised (PIPP-R)
timeFrame: Change from baseline and 70 min
measure: The second sub-purpose Outcome:Neonates The COMFORTneo Scale
timeFrame: Change from baseline and 70 min
measure: The second sub-purpose Outcome: physiological parameters of the premature infant- respiratory rate
timeFrame: Change from baseline and 70 min
measure: The second sub-purpose Outcome: physiological parameters of the premature infant- heart rate (min)
timeFrame: Change from baseline and 70 min
measure: The second sub-purpose Outcome: physiological parameters of the premature infant- oxygen saturation (%SpO2)
timeFrame: Change from baseline and 70 min
measure: The second sub-purpose Outcome: rSO2 level
timeFrame: Change from baseline and 70 min
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
affiliation: Selcuk University
name: Fatma Tas Arslan, Prof
role: STUDY_DIRECTOR
affiliation: Selcuk University
name: Sibel Kucukoglu, assoc. prof.
role: STUDY_DIRECTOR
affiliation: Selcuk University
name: Deniz Kocoglu-Tanyer, assoc. prof.
role: STUDY_CHAIR
affiliation: Selcuk University
name: Hanifi Soylu, Prof
role: STUDY_CHAIR
affiliation: Selcuk University
name: Murat Konak, assoc. prof.
role: STUDY_DIRECTOR
affiliation: Konya Ereğli State Hospital
name: Sevinc Akkoyun, Msc
role: STUDY_DIRECTOR
References: